E Liberate 2

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Editors
Pat Posa, RN, BSN, MSA, CCRN-K, FAAN
Quality and Patient Safety Program Manager
Michigan Medicine
Ann Arbor, Michigan, USA
No disclosures
Jaspal Singh, MD, MHA, MHS, FCCM

Medical Director Critical Care Education and Practice
Atrium Health
Critical Care Network
Charlotte, North Carolina, USA
Honoraria from Somnoware™ Sleep Solutions and Medtronic™ Global Lung Health Solutions.
Joanna L. Stollings, PharmD, FCCM, FCCP

MICU Clinical Pharmacy Specialist
Critical Illness Brain Dysfunction Survivorship Center
Vanderbilt University Medical Center
Nashville, Tennessee, USA
No disclosures
Contributors
Carmen Mabel Arroyo-Novoa, RN, PhD, FCCM
Associate Professor
University of Puerto Rico
San Juan, Puerto Rico
Puerto Rico Society of Critical, Intensive, and Coronary Care Medicine: Advisor to Board of
Directors, Member of Scientific Committee
Yasaman O. Back, MS
Health Services Researcher, Critical Care
Information and Analytic Services
Clinical Analytics
Atrium Health
No disclosures
Michele C. Balas, PhD, RN, CCRN-K, FCCM, FAAN

Associate Professor
Center for Healthy Aging, Self-Management, and Complex Care
College of Nursing
The Ohio State University
Columbus, Ohio, USA
Research support by the NIH under grant number 1R01HL146781-01 and the American Association
of Critical Care Nurses. Past honoraria from the Society of Critical Care Medicine for activities
related to its ICU Liberation campaign
Mary Ann Barnes-Daly, MS, RN, CCRN-K, DC

Clinical Performance Improvement Consultant
Sutter Health Systems
Sacramento, California, USA
No disclosures
Juliana Barr, MD, FCCM

Associate Professor of Anesthesiology, Perioperative and Pain Medicine
VA Palo Alto
Palo Alto, California, USA
No disclosures
Mélanie Bérubé, PhD, RN

Ingram School of Nursing
McGill University
Montréal, Quebec, CAN
Research Center
Trauma, Emergency and Critical Care Medicine Department
CHU de Quebec of Laval University
Quebec City, Quebec, CAN
No disclosures
Nathan E. Brummel, MD, MSCI

Associate Professor of Medicine
Division of Pulmonary, Critical Care, and Sleep Medicine
Department of Internal Medicine
The Ohio State University Wexner Medical Center
Columbus, Ohio, USA
Supported by the NIH under award K76AG054864. Performed advisory board activities for Arjo and
Merck.
Judy E. Davidson, DNP, RN, MCCM, FCCM

Nurse Scientist
University of California San Diego Health
Scientist
Department of Psychiatry
School of Medicine
University of California San Diego
San Diego, California, USA
No disclosures
John W. Devlin, PharmD, FCCM

Professor
Northeastern University
Boston, Massachusetts, USA
No disclosures
Paige Donahue
BSN Student
College of Nursing
The Ohio State University
Columbus, Ohio, USA
No disclosures
E. Wesley Ely, MD, MPH

Tennessee Valley Health System
Nashville Veterans Affairs Hospital Geriatric Research, Education, and Clinical Center (GRECC)
Division of Allergy, Pulmonary, and Critical Care Medicine
Department of Medicine
Vanderbilt University Center
Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center
Conducted CME activities at international meetings at which his honorarium was sponsored by
Pfizer, Orion, or Abbott and has received grant support from Pfizer and Masimo Inc.
Heidi Engel, PT, DPT

Critical Care Clinical Specialist
University of California San Francisco
San Francisco, California, USA
No disclosures
Alix Fitzgerald, CCLS

Child Life Services
Cleveland Clinic Children’s Hospital
Cleveland, Ohio, USA
No disclosures
Erika Gabbard, DNP, RN, CCNS, CCRN-K

Director of Advanced Practice Clinical Services
Atrium Health
No disclosures
Celine Gélinas, PhD, RN

Ingram School of Nursing
McGill University
Centre for Nursing Research and Lady Davis Institute
Jewish General Hospital
No disclosures
Timothy D. Girard, MD, MSCI

Clinical Research, Investigation, and System Modeling of Acute Illness (CRISMA) Center
Department of Critical Care
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, USA
No disclosures
Brent A. Hall, PharmD

Department of Pharmacy
University of California
Davis Children’s Hospital
Sacramento, California, USA
No disclosures
Ken D. Hargett, MHA, RRT, FAARC, FCCM

Former Director, Respiratory Care Services
Houston Methodist Hospital
Houston, Texas, USA
No disclosures
Christina Hayhurst, MD
Assistant Professor
Division of Anesthesiology Critical Care Medicine
No disclosures
Ramona O. Hopkins, PhD

Pulmonary and Critical Care Medicine
Intermountain Medical Center
Murray, Utah, USA
Center for Humanizing Critical Care
Intermountain Health Care
Murray, Utah, USA
Psychology Department and Neuroscience Center
Brigham Young University
Provo, Utah, USA
No disclosures
James C. Jackson, PsyD

No disclosures
Ruth Kleinpell, PhD, RN, FCCM

Past President, Society of Critical
Care Medicine
Independence Foundation Professor of
Nursing Education
Assistant Dean for Clinical Scholarship,
Professor of Nursing
Vanderbilt University School of Nursing
Board member, American Nurses Credentialing Center; board member, World Federation of
Intensive and Critical Care, board member, Tennessee Nurses Association Political Action
Campaign; annual faculty speaker, American Association of Nurse Practitioners; annual faculty
speaker, American Association of Critical Care Nurses National Teaching Institute
Caroline L. Lassen-Green, PhD, MS

Tennessee Valley Health System
Nashville Veterans Affairs Hospital Geriatric Research, Education, and Clinical Center (GRECC)
No disclosures
John C. Lin, MD
Division of Critical Care Medicine
Department of Pediatrics
Washington University School of Medicine
St. Louis, Missouri, USA
No disclosures
Geraldine Martorella, PhD, RN

College of Nursing
Florida State University
Tallahassee, Florida, USA
No disclosures
Matthew F. Mart, MD
No disclosures
Mark E. Mikkelsen, MD, MSCE

Perelman School of Medicine
University of Pennsylvania
Philadelphia, Pennsylvania, USA
No disclosures
Giora Netzer, MD, MSCE

Associate Professor of Medicine and Epidemiology
University of Maryland School of Medicine
Vice President, Patient Experience
University of Maryland Medical Center
Baltimore, Maryland, USA
No disclosures
Pratik Pandharipande, MD, MSc

Professor
Division of Anesthesiology Critical Care Medicine
Research Grant Pfizer (previously Hospira) Inc.
Brenda Pun, DNP, RN, FCCM

Director of Data Quality
No disclosures
Kathleen Puntillo, PhD

School of Nursing
University of California San Francisco
San Francisco, California, USA
No disclosures
George E. Ross, MBA, HCM, CPHQ

Director, Quality Performance Improvement
Atrium Health
No disclosures
Carla M. Sevin, MD
No disclosures
Yoanna Skrobik, MD
Clinician Scientist
McGill University
Montreal, Quebec, CAN
No disclosures
Paul M. Szumita, PharmD, FCCM

Clinical Pharmacy Practice Manager
Brigham and Women’s Hospital
Boston. Massachusetts, USA
No disclosures
Hector R. Valdivia, ARNP

Pediatric Intensive Care Unit and Clinical Effectiveness
Seattle Children’s Hospital
Seattle, Washington, USA
No disclosures
Kathleen Vollman, MSN, RN, CCNS, FCNS, FCCM, FAAN

Clinical Nurse Specialist/Consultant
Advancing Nursing LCC
Northville, Michigan, USA
Sage Products, a business unit of Stryker.
Gerald Weinhouse, MD
Medical Director, Respiratory Care Services
Brigham and Women’s Hospital
Boston, Massachusetts, USA
No disclosures
Chris Winkelman, PhD, ACNP, CCRN, CNE, FCCM, FAANP

Associate Professor
Frances Payne Bolton School of Nursing Care
Western Reserve University
Cleveland, Ohio, USA
Stryker. I am developing of a survey related to the RN use of Lift and Sling Devices. The survey does
not specifically address products manufactured or distributed by Stryker, but I will receive a fee for
this effort from Stryker.
Jerry Zimmerman, MD, PhD, FCCM

Past President, Society of Critical Care
Medicine
Faculty, Pediatric Critical Care Medicine
Seattle Children’s Hospital, Harborview
Medical Center
University of Washington, School of
Medicine
Seattle, Washington, USA
No disclosures
Contents
Foreword
Ruth Kleinpell, PhD, RN, FCCM, and Jerry Zimmerman, MD, PhD, FCCM
Chapter 1: Introduction to the Bundle

Patricia Posa, RN, BSN, MSA, CCRN-K, FAAN, Jaspal Singh, MD, MHA, MHS, FCCM, and
Joanna Stollings, PharmD, FCCM, FCCP
Chapter 2: Assessment, Prevention, and Management of Pain

Céline Gélinas, RN, PhD, Geraldine Martorella, RN, PhD, Carmen Mabel Arroyo-Novoa, RN,
PhD, FCCM, Mélanie Bérubé, RN, PhD, and Kathleen A. Puntillo, RN, PhD, FAAN, FCCM
Chapter 3: Spontaneous Awakening and Breathing Trials

Timothy D. Girard, MD, MSCI, Ken D. Hargett, MHA, RRT, FAARC, FCCM, and Jaspal Singh,
MD, MHS, MHA, FCCM
Chapter 4: Choice of Analgesia and Sedation

Joanna L. Stollings, PharmD, FCCM, Paul M. Szumita, PharmD, FCCM, and John W. Devlin,
PharmD, MCCM
Chapter 5: Delirium Assessment, Prevention, and Management

Christina J. Hayhurst, MD, and Pratik Pandharipande, MD MSc
Chapter 6: Early Mobility

Chris Winkelman, PhD, ACNP, CCRN, CNE, FCCM, FAANP, Kathleen Vollman, MSN, RN, CCNS,
FCNS, FCCM, FAAN, and Heidi Engel, PT, DPT
Chapter 7: Family Engagement and Empowerment

Giora Netzer, MD, MSCE, and Judy E. Davidson, DNP, RN, MCCM, FCCM
Chapter 8: The Importance of Good Sleep for Recovery From Critical Illness
Gerald Weinhouse, MD, and Yoanna Skrobik, MD
Chapter 9: Strategies to Facilitate Effective Adoption of the ICU Liberation Bundle,

Measurement of Outcomes, and Integration Into Clinical Practice
Michele C. Balas, PhD, RN, CCRN-K, FCCM, FAAN, Paige Donahue, and Nathan E. Brummel,
MD, MSCI
Chapter 10: Post-Intensive Care Syndrome (PICS) and Strategies to Mitigate PICS
Mark E. Mikkelsen, MD, MSCE, Ramona O. Hopkins, PhD, and Carla M. Sevin, MD
Chapter 11: Use of an Interprofessional Team Model in the ICU to Facilitate Performance of
the ICU Liberation Bundle
Mary Ann Barnes-Daly, MS, RN, CCRN-K, DC, and Juliana Barr, MD, FCCM
Chapter 12: Implementation of the ICU Liberation Bundle: Collecting and Using Data for
Quality and Performance Improvement
Brenda Pun, DNP, RN, FCCM, and Pat Posa, RN, BSN, MSA, CCRN-K, FAAN
Chapter 13: Administrators’ Perspective on the ICU Liberation Bundle

Jaspal Singh, MD, MHA, MHS, FCCM, Erika Gabbard, DNP, RN, CCNS, CCRN-K, Yasaman O.
Back, MS, and George E. Ross, MBA, HCM, CPHQ
Chapter 14: ICU Liberation in the Pediatric ICU: Bringing the ICU Liberation Bundle to the
Bedside of the Critically Ill Child
Hector R. Valdivia, ARNP, Brent A. Hall, PharmD, Alix Fitzgerald, CCLS, and John C. Lin, MD
Chapter 15: Future Directions for ICU Liberation

Caroline L. Lassen-Greene, PhD, MS, Matthew F. Mart, MD, James C. Jackson, PsyD, and E.
Wesley Ely, MD, MPH
Foreword
It is with great pleasure that we acknowledge the significant work of the

editors and chapter authors and coauthors of this second edition of ICU
Liberation. It is well recognized that the science behind ICU Liberation
continues to grow as it relates to the benefits of improving care in the ICU
by focusing on adequate pain management, sedation, delirium assessment
and management, early mobility, family engagement, and the importance of
sleep for promoting recovery from critical illness.
Since its inception, the Society of Critical Care Medicine has highlighted
the value of team-based care in the ICU. In recognition of the importance
that ICU teams can collectively achieve, SCCM launched the ICU
Liberation Collaborative with the intent of studying the impact of
recommended best care practices for critically ill patients. The ICU
Liberation Collaborative was a 20-month, nationwide quality improvement
initiative that focused on dissemination and implementation strategies and
tracked key performance metrics to overcome barriers to ABCDEF bundle
adoption. The ICU Liberation Collaborative included more than 15,000
critically ill patients from 68 participating sites and demonstrated
significant (large effect sizes) and dose-related improvements in survival,
duration of mechanical ventilation, neurological organ dysfunction (ie,
delirium and coma), physical restraint use, ICU readmission rates, and
hospital discharge disposition of ICU survivors. At the same time, the
literature documents the challenges of promoting effective adoption and
integration of the ICU Liberation Bundle into usual clinical practice.
Chapters in this second edition of ICU Liberation provide updates on each
of the bundle components and highlight strategies for promoting application
of the bundle components into care, along with emphasis on the importance
of an interprofessional team model to facilitate bundle implementation.
Additional chapters integrate new knowledge related to the prevention of
post–intensive care syndrome (PICS) and strategies to mitigate this key
long-term morbidity among ICU survivors; provide administrative
perspectives underlying the ICU Liberation Bundle; and offer advice for
implementing the ICU Liberation Bundle in pediatric ICU settings.
This second edition of ICU Liberation contains a wealth of knowledge from
experienced clinicians, researchers, and educators who are recognized
experts in ICU care, many of whom were lead faculty for the ICU
Liberation Collaborative. Additionally, the chapter authors and coauthors
are national leaders and experts in the ICU Liberation Bundle. They
represent the various interprofessional members of the ICU team who, on a
daily basis, work to improve care practices for critically ill patients in the
ICU, not only treatment of the primary illness or injury but also delivery of
“usual care” (ICU Liberation elements) to critically ill patients.
This second edition of ICU Liberation highlights that implementation of the
ICU Liberation Bundle alone is not sufficient to improve care for ICU
patients. Rather, continuing to monitor performance of the bundle
components is essential, along with ongoing data collection and review for
iterative quality improvement and performance improvement.
Along with the 2018 SCCM Clinical Practice Guidelines for the Prevention
and Management of Pain, Agitation/Sedation, Delirium, Immobility, and
Sleep Disruption in Adult Patients in the ICU, a similar document about to
be released addressing critically ill children, and the results and lessons
learned from the ICU Liberation Collaborative, this second edition of ICU
Liberation represents a rich resource for ICU clinicians worldwide.
As past presidents of SCCM, we hope that all ICUs adopt the ICU
Liberation Bundle and that future directions for ICU Liberation continue to
inform, guide, support, and champion continued change in ICU practices to
promote optimal outcomes for critically ill patients globally.
Ruth Kleinpell, PhD, RN, FCCM
Jerry Zimmerman, MD, PhD, FCCM
Introduction to the Bundle
Patricia Posa, RN, BSN, MSA, CCRN-K, FAAN, Jaspal Singh, MD, MHA, MHS,
FCCM, and Joanna Stollings, PharmD, FCCM, FCCP
The Society of Critical Care Medicine (SCCM) has endorsed and published
the 2013 Pain, Agitation, and Delirium (PAD) guidelines and the 2018 Pain,
Agitation, Sedation, Delirium, Immobility, and Sleep Disruption (PADIS)
guidelines, which outline the best evidence available for addressing pain,
agitation, delirium, early mobility, and sleep. Many ICUs have found
adoption of the PAD and PADIS guidelines difficult in practice, either as
individual components or when integrated with other aspects of patient
care. Because of the difficulties found with implementation of the
guidelines, an evidence-based, bundled approach was developed to aid in
the clinical application of the PAD and PADIS guidelines, called the ICU
Liberation Bundle. This bundle was formerly referred to as ABCDEF, a
mnemonic representing the key bundle elements: A for Assessment,
prevention, and management of pain; B for Both spontaneous awakening
trials and spontaneous breathing trials; C for Choice of sedation and
analgesia; D for Delirium assessment, prevention, and management; E for
Early mobility and exercise; and F for Family engagement and
empowerment. The ICU Liberation Bundle has been studied in more than
20,000 patients, demonstrating a reduction in ICU days, hospital days, next-
day mechanical ventilation, coma, delirium, hospital mortality, use of
physical restraints, ICU readmissions, transfer to a facility, and healthcare
costs. Despite several studies demonstrating the benefit of compliance with
the ICU Liberation Bundle, global implementation within the ICU has not
yet been established.
The purpose of this book is to provide practical application strategies to
help frontline teams implement the ICU Liberation Bundle. We not only
cover the science behind each bundle element, as delineated in the 2018
PADIS guidelines by SCCM, but also provide practical recommendations to
aid in implementation. The authors of the individual chapters were urged to
share real-world implementation approaches using the evidence as well as
expert opinion. Discussion of common challenges related to implementation
and tactics to overcome barriers are an essential component of each chapter
related to the bundle elements. The book offers strategies for effective
interprofessional team-based care in the ICU, performance improvement
methods, and the use of data to drive implementation of the bundle; in our
experience, attention to all these factors is essential to drive unit and
institutional culture. Stories and examples are used to highlight resources
and financial strategies needed to support and sustain the program.
This book provides a wealth of information, encompassing a broad array of
topics related to ICU Liberation. Leading authors address each element of
the bundle, integrating updates and key evidence as well as lessons learned
since the first edition. The current edition also clarifies the role that sleep
plays in recovery from critical illness, emphasizing that approaching this
topic often requires reengineering of our ICU daily work. We discuss
aspects related to managing team-based interactions, examine updated data
collection methods, and provide insight into patient and family challenges
beyond the ICU [as in post–intensive care syndrome (PICS)]. This edition
provides a dedicated chapter on implementation of ICU Liberation in the
pediatric population and offers insight into how administrators may
approach ICU Liberation.
We hope you enjoy the individual chapters and the updates provided in this
edition. Notably, we designed this book to accompany a simulation training
course for the ICU Liberation Bundle, and we encourage you and your
teams to attend the live courses as well. Regardless, we hope you and your
teams can use the information to catalyze efforts for your own patients and
populations.
Assessment, Prevention, and Management of Pain
Céline Gélinas, RN, PhD, Geraldine Martorella, RN, PhD, Carmen Mabel Arroyo-
Novoa, RN, PhD, FCCM, Mélanie Bérubé, RN, PhD, and Kathleen A. Puntillo, RN,
PhD, FAAN, FCCM
Objectives
Describe appropriate pain assessment strategies for use in

critically ill patients.
Review strategies to prevent and treat pain in critically ill
patients.
Discuss common challenges associated with pain management
in critically ill patients and appropriate strategies.
Key words: pain, pain assessment, pain management, practice

guidelines, critically ill adult
Pain management remains a major issue in intensive care practice, which

may be related to the complexity of pain and the numerous related
challenges. In the 2018 PADIS (Pain, Agitation, Delirium, Immobility, and
Sleep Disruption) clinical practice guidelines of the Society of Critical Care
Medicine (SCCM),1 a total of 25 recommendations and statements are
related to pain management, representing more than 33% of the guideline
content. The first step of the ICU Liberation Bundle addresses the
assessment, prevention, and management of pain.2 Assessing and treating
pain adequately in the acute phase of critical illness are necessary to
optimize recovery and reduce risks for the development of short-term and
long-term problems. Therefore, applying best pain management practice
guidelines from admission throughout the entire ICU stay is the
responsibility of all members of the care team in order to ensure optimal
patient outcomes.
ASSESSMENT OF PAIN
Pain must be monitored in all critically ill adults.1,3 Pain is subjective and
multidimensional; it is construed as a distressing experience associated with
actual or potential tissue damage, with sensory, emotional, cognitive, and
social/behavioral components.4 Therefore, pain is best described by the
individual experiencing it, and the patient’s self-report, which should be
obtained as often as possible, is the gold standard measure of pain.
However, due to their critical conditions, many ICU patients are unable to
communicate about their pain issues. Factors such as endotracheal
intubation, ongoing mechanical ventilation (20%-40% of ICU patients),5
administration of sedatives, and altered consciousness from acute illness
can affect the patient’s perception and communication of pain. The
International Association for the Study of Pain (IASP) has acknowledged
that “the inability to communicate verbally does not negate the possibility
that an individual is experiencing pain and is in need of appropriate pain-
relieving treatment.”6 Other key professional associations such as the
American Society for Pain Management Nursing (ASPMN) and the
American Association of Critical-Care Nurses (AACN) have published a
position statement7 and a practice alert8 addressing pain assessment in the
patient unable to self-report. In alignment with these position papers and the
PADIS guidelines,1 pain assessment methods must be adapted to the
patient’s cognitive capacities and clinical conditions. Behavioral scales are
alternative measures to use in those unable to self-report. Pain should be
monitored and documented on a regular basis both when the patient is at
rest and during activities or procedures. Moreover, responses to medications
are best assessed when pain is monitored prior to administration as well as
at the peak effect of an analgesic.8 Such a practice allows the nurse and care
team to plan for appropriate pain management and preventive measures and
to determine the effectiveness of pain treatment therapies. In this section,
we address the essential steps in pain assessment and highlight the best
tools to use.
Attempt Self-Report
Whenever possible, the patient’s self-report of pain should be obtained. At
ICU admission, a comprehensive assessment of pain can be sought using
the mnemonic technique PQRSTUV (Table 1). Afterward, during the ICU
stay, the patient’s pain intensity should be monitored using the 0 (no pain)
to 10 (worst possible pain) Numeric Rating Scale (NRS) administered
either verbally or visually, as it is a valid and feasible pain scale.1,9,10 Either
a horizontal or a vertical format can be used (Figure 1)9,10; older adults
usually prefer a vertical format because it resembles a thermometer.11
Patients should be taught how to use the NRS and should be encouraged to
point to a visual format of the scale or to answer by signs (eg, head
nodding) when mechanically ventilated.9,10 Pain scores greater than 3 of 10
are described as indicating significant pain3; scores of 1 to 3 indicate mild
pain; scores of 4 to 6 indicate moderate pain; and scores of 7 or higher
indicate severe pain.12-15 A simple yes or no to acknowledge the presence
versus absence of pain also provides useful information when
communication of other information is limited.16
Table 1. PQRSTUV Mnemonic Technique
Component Description Link With Pain Descriptors

P Provocative/palliative factors Pain cause; pain-relieving strategies
Q Quality Pain sensation
R Region Pain location
S Severity Pain intensity
T Time Pain duration (eg, constant, intermittent)
U Understand Previous pain experience and known problems
V Values Values and preferences for pain treatment
Figure 1. Visual formats of the 0- to 10-point numeric rating scale

Figure 1B reproduced with permission. Copyright © 2007 Celine Gélinas, RN, PhD.
When Self-Report Is Not Possible, Use a Standardized Behavioral

Pain Scale
When the patient’s self-report is impossible to obtain, behavioral scales are
alternative measures to use. The Critical-Care Pain Observation Tool
(CPOT)17 and the Behavioral Pain Scale (BPS)18 and its version for the
nonintubated patient (BPS-NI)19 are recommended scales1 as they have
shown the most robust psychometric properties for use in critically ill
adults.20 The established cut-point score for significant pain is greater than
2 for the CPOT (scale of 0-8) and greater than 5 for the BPS or BPS-NI
(scale of 3-12). Behavioral scores and pain intensity scores cannot be used
interchangeably. Although both scores are positively correlated, their values
are not equivalent. Behavioral scales are mainly used to detect the presence
of pain, and it is known (for the CPOT) that the cut-point score is more
effective to identify pain when it is reported as moderate to severe by
patients.21 A CPOT reduction of 2 points or more is used to indicate the
effectiveness of analgesia.22
Consult Family Members About the Patient’s Common Behaviors

Regarding Pain
In addition to the use of a behavioral scale and when the patient is unable to
self-report, the family can be involved in the patient’s pain assessment if
they feel comfortable doing so.1,7,8 For instance, family members could
assist the nurse in identifying less obvious behaviors by the patient that may
be indicative of pain.23-25 This information can be combined with other
evidence including the use of a validated behavioral scale and the presence
of conditions that are known to be painful.16
Vital Signs Are Not Valid Indicators for ICU Pain Assessment
Although vital signs are easily accessible through continuous monitoring in
the ICU, they are not valid indicators of pain and should be used only as
cues to begin further assessment of pain with valid methods.1,7,8,16 Indeed,
the validity of vital signs for pain assessment in the ICU is not supported
due to their various responses to painful stimuli.26 However, changes in
vital signs could be considered as pain-related adverse events27 and should
prompt the nurse to initiate appropriate pain assessment with valid methods
(ie, obtaining the patient’s self-report of pain if able to communicate, and if
the patient is unable to self-report, using a behavioral scale such as the
CPOT or the BPS/BPS-NI).
PREVENTION AND TREATMENT OF PAIN
Pharmacological Therapies
Analgesic pharmacological therapies are described in detail in Chapter 4.
A multimodal analgesic approach is preferable to achieve optimal pain
management; often, lower doses of different analgesic agents are used to
mitigate the risk of adverse effects.1 The use of an assessment-driven,
protocol-based, stepwise approach for pain and sedation management in
critically ill adults is also highly suggested by the PADIS guidelines.1
We developed an algorithm using a 0- to 10-point NRS and the CPOT
(Figure 2) to guide ICU teams in pain management decision making based
on routine pain assessments and interpretation of pain scores. The algorithm
includes regular assessment of pain when the patient is at rest and during
standard care procedures (eg, turning, endotracheal suctioning).28 When
significant pain is detected (ie, NRS > 3 or CPOT > 2), the algorithm
recommends an appropriate multimodal intervention such as the use of
nonpharmacological therapies and the administration of opioid and/or
opioid analgesic administration of a nonopioid and/or opioid analgesic
coupled with subsequent reassessment of pain to determine the
effectiveness of analgesia. Pain assessment scores before and within 1 hour
after opioid administration that show a reduction of more than 2 points on
the NRS29 or more than 2 points on the CPOT22 are considered to be
clinically significant and support the effectiveness of analgesia.
Figure 2. Pain management algorithm
Abbreviations: CPOT, Critical-Care Pain Observation Tool; NRS, Numeric Rating Scale; PRN, as
needed.
Reproduced with permission. Copyright © 2016 Celine Gélinas, RN, PhD.
A systematic, standardized, interprofessional approach to pain management

can improve the assessment and treatment of pain and support quality
initiatives regarding pain management.30 Pain assessment findings and the
pain management plan should be discussed during nursing handoffs and
multidisciplinary rounds or when a change in clinical status occurs which
may require adjustment in the treatment plan. All ICU care team members
should be trained in pain assessment methods and interpretation of pain
scores.8,20
Nonpharmacological Therapies
Given the numerous possible sources of acute pain in the ICU, optimizing
pain management is crucial to relieve pain and prevent chronic pain31,32 as
well as to prevent the development of post–intensive care syndrome.33 The
importance of using nonpharmacological therapies emerged in the previous
guideline version3 and is even more clearly highlighted in the 2018 PADIS
guidelines given that a greater number of studies were conducted on the
topic in the past decade.34 Integrating those therapies is in line with the
recommendation of implementing a multimodal approach to pain
management.1,35 Moreover, those therapies can decrease the use of
analgesic pharmacological therapies, namely opioids, that are known to
generate several side effects and complications in this vulnerable patient
population.36,37 Four therapies—massage, music, cold, and relaxation—
have been studied the most and are suggested for pain management in the
ICU. None of these have thus far been associated with adverse events.1
These therapies may be implemented soon after ICU admission, and
patients’ preferences should be considered whenever possible. Patients (or
family members) can continue to use some of these therapies once the
patient’s medical condition allows or once the patient is discharged from the
ICU. A summary of the characteristics of these therapies and
implementation strategies is provided in Table 2.
Table 2. Description of Nonpharmacological Therapies
Intervention Schedule or Dosage Pain Implementation Other Comments

Management Strategies
Massage 20 minutes Nonprocedural Training Hand or foot area commonly
used
Minimum of 2 massages Cream or lotion
within a 24-hour period Patient’s preference of body
Massage followed area should be considered
by a rest period
Calm
environment
Music and 20-30 minutes Procedural Training Music preferences

sounds
Single or multiple doses Nonprocedural Headsets Familiar sounds
Cold therapy 10-20 minutes Procedural Ice packs

Storage
Relaxation Before a procedure Procedural No material Deep breathing techniques

required
Twice a day Nonprocedural Guided imagery
Self-
administration or
with coaching
Massage Therapies
Massage therapy includes different techniques such as the use of pressure,
rubbing, and manipulation of the muscles and other soft tissues of the body.
Commonly used massage techniques in the ICU include Swedish massage,
effleurage, petrissage, and the application of moderate pressure over
different body areas, including the feet, back, and hands.38
Although the quality of evidence is low due to risk of bias and imprecision,
massage therapy is suggested for nonprocedural pain management in the
ICU.1 Pooled analysis of massage studies has highlighted a decrease of 1
point on a 0- to 10-point NRS or visual analog scale (VAS) after the first
massage and a decrease of up to 2 points after repeated massages.1
Moreover, results from a recent randomized controlled trial (n = 60) showed
a 2-point decrease in pain intensity and pain unpleasantness on a 0- to 10-
point NRS with repetitive massage administration.39 The use of massage in
conjunction with analgesics helps to reduce pain intensity.38 Massage is
safe when performed on the back, feet, and hands or only hands unless a
medical condition interferes with these areas.1 Although pressure is not
always specified in studies, we recommend applying a light pressure as
opposed to moderate pressure unless the provider has received specialized
training.40 For the best response, a minimum of 2 massages of 20 minutes
duration in 24 hours is suggested.1,39 Patients’ preferences of body area
should be ascertained. When possible, this type of intervention can be
followed by a rest period of the same duration as massage. Implementation
barriers commonly encountered are environmental noise and interruptions
from medical visits in the ICU.41 Diminishing sound and light exposure
with simple measures such as dimming lights; reducing alarms volume42;
using earplugs, eye mask, or both43; or care clustering can help maximise
the potential efficacy of massage.44
Diluted lavender oil or lavender aromatherapy has been used during a
massage intervention according to patients’ preferences.45 There are
different types and concentrations of lavender46 and several interactions
exist that critically ill patients may be at higher risk for.41 Hence, at this
time, we do not suggest the use of aromatherapy or essential oil for massage
in the ICU.1
Although previous studies demonstrated that massage could be
administered by nurses following minimal training and resources (cream or
lotion), feasibility studies of its implementation in ICU practice are
lacking.39 Family members could play a role in massage delivery as
explored in previous studies with coaching from nurses.40,43
Music and Sound Therapies

Most of these interventions consist of music listening; when possible, music
preferences of patients should be taken into account. Natural sounds are
also an option, and patients respond to their individual sound
preferences.47,48 Music has been shown to be potentially beneficial for
procedural and nonprocedural pain management in the ICU.1 Pooled
analysis of ICU studies conducted with patients able to self-report showed a
decrease of 0.5 points on a 0- to 10-point NRS for procedural pain and a
decrease of 0.7 points for nonprocedural pain.1 Although these differences
have not yet shown clinical significance, we believe this intervention
deserves consideration given its feasibility, the potential benefits, and the
absence of harmful effects. Two recent randomized controlled trials of
music in mechanically ventilated patients (n = 9049; n = 6050) reported
significant differences in nonprocedural and procedural pain scores (BPS or
CPOT) when compared with standard care49 or noise reduction,50 with a
mean difference ranging from 0.6 to 2.6 points. This intervention can be
implemented with analgesics or alone when pain is mild.51,52 Duration of
music interventions was highly variable across studies but on average
entailed 20 to 30 minutes, with longer durations for nonprocedural pain
management.34 Single doses can be administered and repeated daily. Most
of these interventions require the use of headsets, which may pose a
challenge with infection prevention and control guidelines. Live music
(harpist)53 and singing54 have also been studied. However, depending on
the ICU environment, these options may present some implementation
barriers. Although not extensively studied, an interesting and simple
approach is to use familiar sounds.55 A calming voice has been used during
painful procedures for critically ill patients.56 Family members could be
involved in music delivery. Family members may also provide a calming
voice, and in cases where a family member is not present, the recorded
voice of a significant other is a feasible alternative.
Cold Therapy
Cold therapy may be performed in different ways. In studies that were
analyzed in the PADIS guidelines, cold therapy included the use of ice
packs wrapped in dressing gauze and applied for a specific duration of time
(usually 10 to 20 minutes) on a specific body area.1 Cold therapy has been
used for procedural pain management in the ICU.1 Pooled analysis has
highlighted clinically meaningful pain reductions from cold therapy: up to 2
points on a 0- to 10-point NRS.1 Cold therapy is commonly used in
conjunction with analgesics but has also been shown effective in patients
not receiving any form of analgesic pharmacological therapy.57-60 For
instance, in a recent randomized controlled trial (n = 90),59 a decrease of 1
point on a 0- to 10-point VAS was recorded during chest tube removal
(CTR). Of note, the effects were not maintained 15 minutes after the
procedure. This intervention consists of applying gauze-covered ice packs
(usually at a temperature of 0°C [32°F]) for 10 to 20 minutes before a
procedure until the skin reaches 13°C (55.4°F). Cold therapy can be safely
combined with music (listening to music 15 minutes before and 15 minutes
after the procedure).61,62 Although this combination may reduce anxiety, it
has not been shown to be superior to cold therapy alone regarding a
decrease in pain intensity. Cold therapy is implementable by nurses, and the
material resources are inexpensive. A protocol would be required to provide
a guideline in terms of storage, temperature, application, and removal.
Relaxation
Relaxation techniques refer to various practices such as progressive
relaxation, guided imagery, biofeedback, self-hypnosis, and deep breathing
exercises. The goal is to produce the body’s natural relaxation response,
characterized by slower breathing, lower blood pressure, and a feeling of
increased well-being.63
Relaxation therapy has been performed for procedural and nonprocedural
pain management in the ICU.1 Despite small samples and quasi-
experimental designs,34 pooled analysis has shown clinically significant
reductions of pain intensity—2.5 points on a 0- to 10-point VAS.1
Relaxation therapies can be used twice a day or administered 5 minutes
before chest tube removal or other procedures.45,58,64-66
Guided imagery and deep breathing are the most frequently used relaxation
therapies in critically ill patients.34,56,67 For guided imagery, audiotapes and
headsets are used, which will require the staff to follow an infection
prevention and control protocol. In guided imagery, attention is directed
away from unpleasant sensations to peaceful scenarios using positive
suggestions, imagination, and visualization, allowing the participant to enter
a relaxed state.68 Symbolic images are considered powerful healing images
because patients draw such images from their individual beliefs and
culture.69 Regarding deep breathing, different techniques have been tested.
Nurses usually are the providers who will give patients instructions on deep
breathing. For example, when deep breathing is used to ease chest tube
removal, patients are asked to inhale, hold their breath, breathe out, go limp,
and start yawning (the chest tube is removed at the end of the yawn).65 As
another example, patients are told to inhale slowly through the nose and
exhale slowly through pursed lips with eyes closed or focusing on an
object.66
Relaxation therapies are relatively simple to implement, can be self-
administered by patients, and do not require expensive material resources.
No adverse events related to these therapies have been reported. Brochures
can be provided to remind patients of the techniques and encourage their
use for other care procedures or situations.
Bundled Interventions
Bundling of interventions has emerged as an interesting multimodal
approach.34 Bundles include a combination of interventions recommended
in the guidelines.1 Interventions included guided imagery with music,54,70,71
and two studies added gentle touch or massage provided concomitantly for
a total of 3 modalities.70,71 A randomized controlled trial testing 3
modalities in cardiac surgery patients (n = 104) reported pain reduction
ranging between 1.5 and 2.5 points on a 0- to 10-point NRS.70 A second
randomized controlled trial testing 3 modalities in critically ill patients with
various conditions (n = 60) reported a reduction of 1 point on the CPOT and
1.4 points on a 0- to 10-point NRS on day 1 of the intervention, with the
experimental group having a mild level of pain intensity and the control
group maintaining a moderate level of pain intensity.71 Bundled
interventions follow the same type of schedule and require the same
resources as single interventions.
CHALLENGES IN PAIN MANAGEMENT AND

STRATEGIES
“The very first requirement in a hospital is that it should do the sick
no harm.”
—Florence Nightingale,
Notes on Nursing: What It Is, and What It Is Not
Avoiding Opioid-Related Iatrogenic Withdrawal Syndrome

Many situations may predispose ICU patients to the development of opioid-
associated iatrogenic withdrawal syndrome (IWS). Withdrawal syndrome is
a set of signs and symptoms that may occur when a drug is discontinued, or
the dose of a drug is reduced.72 In this case, we are referring to opioids.
IWS can occur when providers do not recognize patients at risk of
withdrawal syndrome (WS) or do not implement measures to prevent it.73
Patients admitted to the ICU might be current opioid users (illicit or
prescribed) or, alternately, might be opioid-naïve (never used or not used in
the previous 6 months) but are exposed to these drugs during a prolonged
ICU stay.73 Whether current or new users, patients with opioid
dependencies are at risk for IWS. A limited number of studies have reported
an ICU IWS prevalence that ranges from 17% to 100%.74-81 However,
because ICU patients often receive opioids and benzodiazepines
concurrently, it can be difficult to determine which medication is the
predominant contributor to IWS.
The scant literature about IWS in adults reports the following risks or
associated factors (in addition to the high or prolonged use of opioids): slow
weaning from infused opioids, diagnosis of adult respiratory distress
syndrome or septic shock, extended propofol therapy, young age, high body
mass index, history of a drug use disorder, and alcoholism.74-78,80 Providers
should continuously assess for these risk factors as well as for the signs and
symptoms that characterize IWS.
The primary signs and symptoms of IWS are central nervous system
irritability (eg, restlessness, irritability, dysphoria, insomnia),
gastrointestinal dysfunction (eg, diarrhea, nausea, vomiting), and
sympathetic nervous system activation (eg, fever, high blood pressure,
lacrimation, tachypnea, yawning, piloerection, sweating, mydriasis).72,74,81-
82 Unfortunately, no reliable and validated tool is available for measuring
IWS in critically ill adults. Moreover, many of the signs and symptoms of
IWS occur in several common ICU conditions, making identification of
IWS challenging. The criteria established by the Diagnostic and Statistical
Manual of Mental Disorders (Fifth Edition) for identifying WS have been
used in some studies: (a) discontinuation or reduction of opioid doses after
high or prolonged use, (b) development of 3 or more signs or symptoms of
WS opioids, and (c) determination that the signs or symptoms are not
related to another clinical condition.72
The algorithm depicted in Figure 3 suggests a clinical approach that might
be applicable to IWS prevention and treatment. Providers should assess the
patient’s history of opioid exposure and determine the substance that may
have been used and the quantity and frequency of that use. Then, if
pertinent, the providers should integrate strategies to prevent or treat IWS,
according to the exposure history.
Figure 3. Algorithm for prevention and treatment of iatrogenic withdrawal syndrome (IWS)
Abbreviations: D/C, discontinue; DEX, dexmedetomidine; NSAID, nonsteroidal anti-inflammatory
drug; OIH, opioid-induced hyperalgesia; OP, opioid; Pt, patient.
Modified with permission from Arroyo-Novoa CM, Figueroa-Ramos MI, Puntillo KA. Opioid and
benzodiazepine iatrogenic withdrawal syndrome in patients in the intensive care unit. AACN Adv Crit
Care. 2019;30:353-364. ©2019 by AACN. All rights reserved.
To prevent development of IWS, the target is to minimize the use of

opioids. PADIS guidelines promote the use of nonpharmacological
therapies (eg, massage, music therapy, relaxation techniques) and
multimodal analgesics.1 Acetaminophen IV, low-dose ketamine, and
neuropathic pain medications, among others, are recommended because
they can have an additive or a synergistic effect with opioids or with each
other.1 Although some studies have reported both reduced opioid
consumption and lower pain-intensity scores with the use of these agents,
other studies have shown inconsistent results.1,83
For patients who are current opioid users (and who may be both tolerant
and dependent), prevention might be more challenging than it would be for
naïve patients, for multiple reasons. Current opioid users require higher
doses of opioids to achieve analgesia.84 Those who use illicit drugs,
especially, might be subject to social prejudice and might suffer the
consequences of their healthcare providers’ lack of knowledge about
dependence.85 In addition, patients might hide their dependence to avoid
being judged or because they fear that opioids might be withheld,85 putting
these patients at risk for inadequate pain treatment with insufficient doses of
opioids, which could trigger IWS. To prevent such an occurrence, sufficient
doses of opioids should be given, or a substitute therapy such as methadone
might be considered. The studies on methadone have been inconsistent in
their findings regarding IWS prevention. However, the times needed to
wean off both infused opioids86 and mechanical ventilation87 have been
reduced with the use of methadone. Low-dose ketamine can also be
beneficial to opioid-dependent patients, due to its ability to reverse
tolerance.88 However, studies with a high level of evidence should be
undertaken to allow stronger or definitive recommendations. Another
strategy is to avoid rapid opioid discontinuation; this applies to both naïve
patients enduring high or prolonged opioid use in the ICU and chronic
opioid users. Also challenging is when tolerance is confused with opioid-
induced hyperalgesia, a condition that provokes an exaggerated pain
response89 and for which treatment may include discontinuation of
opioids.73
Should IWS occur despite the implementation of prevention strategies, the
opioid infusion can be reestablished at its previous level and tapered slowly
to the lowest effective dose. The intensity of signs and symptoms may
affect the pace and the success of this approach. In addition, switching to
long-acting agents such as methadone might be considered, a
recommendation based on the principles of its use in opioid withdrawal
treatment in other non-ICU populations.90 Clonidine and dexmedetomidine,
respectively, were used to decrease IWS symptoms in mechanically
ventilated patients after sedation interruption and in 2 ICU patients with
drug use disorder.91,92 Finally, for patients who cannot be weaned from
opioids or mechanical ventilation, a consultation with a psychiatrist or
addiction-medicine specialist may be needed.
As noted, the algorithm is based on the limited theoretical and empirical
evidence available in both ICU and non-ICU literature, so it should be used
with caution. Rigorous studies with larger samples size are needed to
validate this algorithm and make stronger recommendations, and individual
patient variability can alter the application of such algorithms.
Avoiding Transition to Chronic Pain

Cohort studies conducted in ICU survivors have shown that 30% to 50% of
survivors experience moderate to high degrees of chronic pain 6 months to
1 year after their ICU stay.93-97 Shoulders have been among the pain sites
most often identified in patients with chronic post–intensive care pain
(CPIP).94-96 Battle et al94 formulated several hypotheses to explain shoulder
pain, including the invasive equipment applied to this area of the body
during ICU hospitalization (central lines, ventilator, tubing), joint
immobility for days or weeks, and the undue strain put on shoulders when
patients change position in bed. Other frequently reported CPIP sites
include the lower limbs and lumbar or cervical spine.94-97 These pain sites
could be related to a return to daily living activities while patients are
recovering from the post–intensive care syndrome,98 often experienced by
survivors of critical illness.
Chronic pain can restrict mobility and daily activities and decrease
psychological well-being and the patient’s overall health status.99
Consequently, the per-person cost to manage chronic pain was recently
reported to be more than 50% higher than the cost for a comparable patient
without chronic pain in the United States.100 These consequences are
particularly true for high-impact chronic pain, defined as persistent pain that
substantially limits life or work activities.101,102 Compared with individuals
who have low-impact chronic pain, those with high-impact chronic pain
reported greater pain-related interference with activities, lower quality of
life, and more frequent use of healthcare services for pain.103 A few studies
have documented the impact of CPIP. Baumbach et al95 showed that 58% of
patients who were hospitalized in the ICU for sepsis or septic shock
reported a moderate to severe limitation in daily activities related to pain at
6 months after discharge. Hayhurst et al97 demonstrated that 22% of ICU
medical and surgical patients still suffered from moderate to severe pain
interference with activities at 12 months after discharge. Moreover, patients
with CPIP obtained physical and mental quality of life scores below
country-specific norms.93,104,105 A negative impact on employment (ie,
becoming unemployed, switching to part-time work, or taking long-term
sick leave) was reported in 28% of patients who reported high-intensity
CPIP at 1 year after ICU discharge.105 Similarly, a quarter of patients with
CPIP needed help with daily living activities at the same follow-up time
point.105
Risk Factors for CPIP
Several interrelated risk factors for chronic pain have been identified. These
risk factors are not mutually exclusive and have not been studied in ICU
patients solely. These risk factors can be classified as genetic,
sociodemographic, clinical, and psychosocial (Table 3). Intense acute pain
has been the most frequently acknowledged risk factor in various
populations.106-109 Hence, poor pain management in the ICU may place
patients at risk for CPIP.
Table 3. Risk Factors for Chronic Post–Intensive Care Pain
Genetic Sociodemographic Clinical Psychosocial

Genes and heritability112 Transformations in Female sex104 Surgical procedure113,114 Anxiety
gene expression (epigenetics) caused by
environmental stressors115,116 Age—younger or Inflammation95,104 Depression104
older94,104
Intense acute pain106-109
Evidence-Based Strategies for the Prevention of CPIP

Little is known about the prevention of acute to chronic pain transition
through use of pharmacological therapies in the ICU. Nonetheless,
evidence-based practice guidelines on the management of acute pain can
provide relevant information considering that acute pain has been identified
as an important risk factor for chronic pain. In this regard, recent guidelines
for the prevention and management of pain in the ICU report moderate
quality of evidence for the use of neuropathic pain medication as an adjunct
to opioids in patients presenting with neuropathic pain and for the lowest
effective opioid dose in patients undergoing a painful procedure.1
Recommendations with very low evidence were provided for the use of
acetaminophen, ketamine, and nefopam. Moreover, the routine use of
NSAIDs and lidocaine were not recommended, given their small beneficial
effects versus the serious potential safety concerns they raise.
In addition to the nonpharmacological therapies described earlier in this
chapter, early mobilization and rehabilitation during and after the ICU stay
have been proposed to prevent the development of chronic pain.1,94,96 Early
mobilization of critically ill people looks promising and was shown to be
safe in patients with cardiovascular, respiratory, and neurological stability.1
Post-ICU rehabilitation is defined as a structured rehabilitation exercise
program or training, provided on the general ward or in the community, and
lasting up to 12 weeks.110 However, evidence to support the effectiveness of
follow-up and rehabilitation services after ICU discharge to improve long-
term pain-related outcomes is still insufficient, and future research is sorely
needed.111
Chronic pain is a prevalent issue in ICU survivors, and many adverse
consequences have been associated with this disorder. Some risk factors for
CPIP have been identified, which might guide critical care clinicians in the
timely implementation of interventions to prevent the development of
chronic pain. Increasing interest has turned to the development and
evaluation of these interventions in the last decade. However, more research
is needed to define the role of preventive pharmacological,
nonpharmacological, and rehabilitation interventions in the prevention of
CPIP.
SUMMARY
Successful pain management requires adequate pain assessment using
appropriate methods based on the patient’s capacity to communicate.
Family members should be consulted regarding behaviors indicative of pain
in patients unable to self-report. Training in pain assessment methods
should be offered to all members of the multidisciplinary team to optimize
communication and clinical decisions for pain management. Assessment-
driven pain management protocols should include validated tools and a
multimodal analgesic approach to optimize clinical practices and patient
outcomes. Attention should be paid to the possibility of adverse outcomes
of pain management such as development of IWS in those receiving opioids
and the transition from acute to chronic pain.
KEY POINTS
Pain should be monitored in all critically ill adults through the use of
appropriate and valid assessment methods.
Pain assessment should be used to guide clinical decisions for pain
management, and pain reassessment is key to determine the
effectiveness of analgesia.
A multimodal analgesic approach including pharmacological and
nonpharmacological therapies must be promoted to achieve effective
analgesia while reducing the risk of adverse events.
Iatrogenic withdrawal syndrome may be present in ICU patients
receiving prolonged opioids in the ICU or those who were tolerant of
or dependent on opioids before ICU admission.
There are several reasons why ICU patients with acute pain may
transition to the development of chronic pain. Appropriate attention to
their pain management may help to prevent this debilitating condition.
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Spontaneous Awakening
and Breathing Trials
Timothy D. Girard, MD, MSCI, Ken D. Hargett, MHA, RRT, FAARC, FCCM, and
Jaspal Singh, MD, MHS, MHA, FCCM
Objectives
Review the rationales supporting spontaneous awakening and

breathing trials in the ICU.
Describe practical considerations in the approach to conducting
spontaneous awakening and breathing trials in the ICU.
Highlight issues and considerations in the coordination of
spontaneous awakening and breathing trials.
Key words: sedation, mechanical ventilation, safety, protocol
The coordination of awakening and breathing trials is one of the

cornerstones of liberation from mechanical ventilation. To begin, we define
spontaneous awakening trial (SAT) as a period during which sedating
medications that are being used to treat an ICU patient are held in order to
determine whether the patient requires ongoing sedation or can be managed
without sedatives for the near future. Likewise, we define spontaneous
breathing trial (SBT) as a period during which mechanical ventilation to
treat an ICU patient is held (or decreased to provide only minimal support)
to determine whether the patient requires ongoing mechanical ventilation or
can possibly breathe successfully without the assistance of a ventilator for
the near future.
In critical care, a major paradigm shift has evolved over the last several
decades regarding the use of SATs and SBTs. The previous norm was the
gradual reduction of sedation and ventilator support (ie, “weaning”), an
approach that has been rightfully challenged based on results of randomized
clinical trials. Today, ICU care is more focused on “liberation”—the
removal of sedation and mechanical respiratory support at the earliest
opportune time. This is not to say that some patients do not benefit from the
weaning process, but rather that the general focus on liberation likely better
serves the critically ill population. Indeed, operationalizing the SAT and the
SBT to examine different aspects of a patient’s condition—the former
neurological function, the latter respiratory function—has been pivotal in
this paradigm shift in critical care.
The SAT and SBT share some important principles:
Both the SAT and SBT help to determine a patient’s need (or lack
thereof) for ongoing intensive care with sedatives and/or mechanical
ventilation.
Both the SAT and SBT rely on the patient’s spontaneous trial—(ie,
“occurring without apparent external influence, force, cause, or
treatment”1).
Both more reliably predict a patient’s ongoing needs than does
clinician judgment, which is often overly conservative.
Both require careful coordination and communication by the care
team, specifically highlighting the roles of interprofessional team
members in a team approach to the care of an ICU patient.
This paradigm shift has been met with skepticism over the years and has
entailed many operational hurdles to facilitation of safe and effective SATs
and SBTs. Since then, substantial data have demonstrated that (1) these
trials, when conducted as described in this chapter, are safe, (2) often lead
to improved clinical outcomes, and (3) can improve operational efficiency.
Thus, the SAT-SBT combination is at the heart of the ICU Liberation
Bundle, with both initiatives being sequenced and coupled. This chapter
expands on the history, the evidence, and the pragmatic approach to the
SAT-SBT in today’s critical care environment.
THE SPONTANEOUS AWAKENING TRIAL (SAT)
The SAT is designed to assess whether a patient who is being sedated
(whether by continuous infusion or frequent boluses of a sedative) requires
ongoing sedation or can be managed without sedatives for the near future.
Moving from gradual reduction of sedating medications to rapid
discontinuation has evolved substantially over the years and will continue
to do so as practices, assessment instruments, and therapies evolve. Kress
and colleagues2 labeled their approach “daily interruption of sedatives”
when used in their seminal randomized trial, which first demonstrated the
safety and efficacy of spontaneous awakening trials, but we now prefer the
phrase “spontaneous awakening trial”3 because (1) it emphasizes the patient
(who ideally is awake and comfortable during intensive care) rather than the
treatment and (2) it calls to mind the close relationship that this approach to
managing sedatives has with the SBT, its close correlate.
The main principle underlying the SAT is that the patient provides the safest
and most accurate source of information about his or her need for ongoing
treatment with sedatives. We as clinicians often believe that we can predict
a patient’s ongoing need for sedation and other treatments in the ICU, but
studies show we are often mistaken, perhaps because we are overly
cautious. In one of the earliest and most important trials of ventilator
weaning, for example, Esteban and coworkers4 found that 76% of the
mechanically ventilated patients enrolled in their trial met objective criteria
for liberation from the ventilator at the time of study entry (and nearly 90%
of these were immediately extubated!). Physicians managing these patients
had presumably assumed that mechanical ventilation was still required and
therefore had not proceeded toward extubation. Similarly, in the Awakening
and Breathing Controlled (ABC) Trial,3 patients in the intervention arm
successfully passed 94% of 895 SATs conducted during the trial. In
contrast, clinicians managing sedation in the control group believed that
discontinuation of sedatives was warranted before an SBT in only 31% of
patients.
Multiple lines of evidence have demonstrated that clinicians often
underappreciate the ability of patients to undergo safe discontinuation of
sedation. The dramatic results highlighted above, however, were met with
much skepticism about patient safety, operations, and existing practice
standards. Nonetheless, the evidence supports broad adoption of an SAT
approach in critical care units. Later in the chapter we provide some advice
regarding successful SAT practices.
THE SPONTANEOUS BREATHING TRIAL (SBT)

Mechanical ventilation, despite being a tremendous medical advancement
and lifesaving measure, is also associated with many complications. Thus,
discontinuation of mechanical ventilation at the earliest opportune time is
an important goal and often a measure of institutional performance. The
SBT is designed to assess whether the patient’s respiratory mechanics are
favorable enough to consider liberation from mechanical ventilation.
Weaning is generally considered to entail the gradual reduction of
mechanical support, including the reduction of Fio2 and ventilator
parameters such as positive end-expiratory pressure (PEEP) and mechanical
rate. Weaning may also include changing from nonconventional respiratory
support (eg, airway pressure-release ventilation) to those modes that
promote patient triggering and/or more spontaneous breathing. The
spontaneous breathing component is often assessed through use of pressure
support ventilation modes while the underlying condition that required
mechanical ventilation improves. When the patient meets specific safety
parameters, daily SBTs are used to determine the patient’s ability to sustain
respirations with little to no ventilatory support.
The SBT has been shown to be a safe and effective method of determining a
patient’s ability to maintain adequate oxygenation and ventilation without
mechanical ventilator support. Early work by Esteban et al4 and Ely et al5
demonstrated the benefits of allowing patients to breath spontaneously and
establishing a process for daily assessment for liberation from the ventilator.
In 2001, a collective task force of the American College of Chest
Physicians, American Association for Respiratory Care, and American
College of Critical Care Medicine formally recommended daily SBTs
instead of gradual reduction of ventilator support to promote early
discontinuation of ventilation.7 In 2008, Girard et al3 highlighted the
benefits of pairing the SBT with the SAT.
THE EVIDENCE
Although a detailed discussion of the randomized trials supporting SATs
and SBTs is beyond the scope of this chapter and is available elsewhere,8
several recent investigations documenting the effects of real-world
implementation of spontaneous awakening warrant highlighting. In light of
the robust evidence from early trials2 showing that SATs improve outcomes
of mechanically ventilated ICU patients, and per the recommendations of
authoritative clinical practice guidelines,8,10,11 a growing number of
institutions across the United States and worldwide have implemented these
practices in their ICUs. Published reports of these experiences are
beginning to emerge in the literature.
In a single-center project, Balas and colleagues12 implemented an ABCDE
bundle that included awakening and breathing trial coordination, delirium
monitoring/management, and early exercise/mobility in 5 ICUs at the
Nebraska Medical Center; the investigators compared the management and
outcomes of 93 mechanically ventilated patients treated during the 8
months prior to ABCDE implementation versus 94 mechanically ventilated
patients treated during the 7 months after implementation. Although
compliance with SATs and SBTs did not approach 100%, patients managed
with the ABCDE bundle were significantly more likely to undergo an SAT
(53% vs 71.2%; P = 0.04) and an SBT (70.7% vs 84%; P = 0.03) and
experienced a significant increase in days breathing without mechanical
assistance (median [interquartile range] ventilator-free days, 24 [7-26] vs 21
[0-25]; P = 0.04). Additionally, across the entire ICU cohort studied (187
ventilated patients and 113 nonventilated patients), those managed with the
ABCDE bundle were less likely to develop delirium, even after adjustment
for potential confounders (odds ratio [OR] for delirium, 0.55; 95%
confidence interval [CI], 0.33-0.93; P = 0.03).
In a large, multicenter, quality improvement collaborative carried out by the
Centers for Disease Control and Prevention, Klompas and coworkers13
implemented coordinated SATs and SBTs in 12 ICUs (accounting for 5,164
consecutive episodes of mechanical ventilation) using an opt-out model
wherein nurses and respiratory therapists were responsible for conducting
daily coordinated awakening and breathing trials as long as safety criteria
were met. The project resulted in dramatic increases in the frequency of
both SATs and SBTs (Table 1), which translated to significant
improvements in several outcomes. After adjustment for changes in case-
mix, the rate of ventilator-associated events per episode of mechanical
ventilation was reduced with implementation of SATs and SBTs (OR, 0.63;
95% CI, 0.42-0.97), duration of mechanical ventilation was shortened by
2.4 days (95% CI, 1.7-3.1 days), and lengths of stay in the ICU and hospital
were shortened by 3.0 days (95% CI, 1.6-4.3 days) and 6.3 days (95% CI,
4.0-8.6 days), respectively.
Table 1. Frequency of SATs and SBTs Before and After the CDC Prevention Epicenters Wake Up and Breathe
Collaborative
Procedure Beforea Afterb P Value

SATs performed, % of days SAT indicated 14 (7.1-26) 77 (61-87) <0.0001
SBTs performed, % of days SBT indicated 49 (35-63) 75 (64-84) <0.0001
SBTs performed with sedatives off, % of all SBTs 6.1 (3.9-9.4) 87 (81-92) <0.0001
Abbreviations: SAT, spontaneous awakening trial; SBT, spontaneous breathing trial.
aDuring first month of data collection.
bDuring last month of data collection.
Data from Klompas et al.13 Data in parentheses are ranges.
Most recently, Pun and coworkers14 conducted the SCCM ICU Liberation
Collaborative, a nationwide quality improvement initiative that
implemented the ICU Liberation Bundle in 68 academic, community, and
federal ICUs. In a project that involved 15,226 patients, Pun et al found that
complete performance of the ICU Liberation Bundle was associated with
improvements in numerous outcomes, including next-day mechanical
ventilation (adjusted odds ratio [AOR], 0.28; 95% CI, 0.22-0.36), coma
(AOR, 0.35; 95% CI, 0.22-0.56), delirium (AOR, 0.60; 95% CI, 0.49-0.72),
use of physical restraint (AOR, 0.37; 95% CI, 0.30-0.46), ICU readmission
(AOR, 0.54; 95% CI, 0.37-0.79), and hospital death within 7 days (adjusted
hazard ratio, 0.32; 95% CI, 0.17-0.62).
One recent, negative randomized trial of SATs was instructive regarding the
mechanism of benefit when implementing SATs. The SLEAP
Investigators15 conducted a multicenter randomized trial comparing
protocolized sedation alone versus protocolized sedation plus daily SATs
and found no difference in outcomes. But, unlike the awakening trials
conducted by Kress et al2 or those conducted in the ABC Trial,3 which both
markedly reduced exposure to sedatives, the awakening trials conducted in
the SLEAP trial had the opposite effect: Compared with patients managed
without sedation interruption, the patients managed with SATs received
significantly more benzodiazepines and opioids in terms of overall dose (P
= 0.04 for benzodiazepine equivalents, P < 0.001 for fentanyl equivalents)
and dose via intravenous boluses (P = 0.007 for benzodiazepine
equivalents, P < 0.001 for fentanyl equivalents). These differences suggest
that during the SLEAP trial, SATs (which occurred on 72% of eligible study
days) were likely brief and often accompanied by additional bolus doses of
sedatives. When these results are interpreted in the context of investigations
showing that SATs resulted in reduced sedation and improved alertness, the
message is that the mechanism of benefit for SATs is primarily avoidance of
unnecessary sedation. Thus, awakening trials that are followed by (or
concurrent with) additional sedation via intravenous boluses are likely to be
of less benefit than those that result in discontinuation of sedatives.
In aggregate, these studies support that the SAT and SBT are of paramount
importance in most ICUs. Additional evidence is accumulating that
supports the use of SATs and SBTs in surgical, pediatric, neurological /-
neurosurgical, and cardiovascular / cardiothoracic critical care units and is
constantly being updated on the Society of Critical Care Medicine’s
resource page
(https://www.sccm.org/ICULiberation/Resource-Library).
APPROACHING SPONTANEOUS AWAKENING TRIALS
Eligibility, Safety Screen of the SAT

Every SAT should begin with a safety screen (Figure 1). This step is
essential because on any given day in the ICU, each patient is unique not
only compared with other patients but also compared with his or her own
state on previous days. For example, it may have been unsafe to interrupt a
patient’s sedation during the first day in the ICU when he or she was having
ongoing agitation, but an SAT may be safe today if the patient’s agitation
has resolved. The safety screen gives the provider who is managing
sedation, typically the bedside nurse, objective criteria by which to
determine whether an SAT should be conducted on a given day.
Figure 1. Wake up and breathe protocol flowchart
Abbreviations: PEEP, positive end-expiratory pressure; Spo2, oxygen saturation.
© 2008 Vanderbilt University. All rights reserved.

During the ABC Trial,3 spontaneous safety screen criteria were
operationalized. Seizures or alcohol withdrawals were considered “active”
if a sedative infusion was currently being used by the ICU team to
specifically treat one of these conditions. Thus, any uncertainty about the
indication for a sedative infusion should be resolved via communication
between the bedside nurse and the treating physician. Agitation was
considered present if sedative doses had been escalated (via either infusion
or bolus dosing) during the 6 to 8 hours before assessment with the safety
screen. Paralytics resulted in failure of the safety screen if they were still
being administered or if their effect had not yet worn off, according to the
bedside nurse. Myocardial ischemia was considered active if, in the
previous 24 hours, cardiac enzymes had increased, or changes indicative of
ischemia were noted on electrocardiography. Finally, intracranial pressure
(ICP) was considered elevated if ICP elevation was noted by the treating
ICU team. As shown in Table 2, agitation requiring escalating sedatives
doses accounted for 75% of SAT safety screen failures; all other criteria
were rarely observed. It should be noted, however, that the frequencies of
these conditions will vary depending on the patient population being
managed.
Table 2. Reasons for SAT Safety Screen Failure During the Awakening and Breathing Controlled Trial
Criteria SAT Safety Screens, n (%)
(N = 1,140)
Sedative infusion for seizures or alcohol withdrawal 11 (1)
Agitation requiring escalating sedative doses 151 (13)
Paralytics 26 (2)
Active myocardial infarction 18 (2)
Elevated intracranial pressure 3 (0.3)
Abbreviation: SAT, spontaneous awakening trial.
Previously unpublished data from the Awakening and Breathing Controlled Trial.3
When designing the ABC Trial protocol3 and developing the safety criteria
shown in Figure 1, the investigators targeted the medical ICU patient
population. Some conditions or circumstances that could make an SAT
unsafe are not listed in the figure because they are typically encountered
only in the care of surgical patients. However, the ICU Liberation
Collaborative featured many institutions with successful SAT-SBT
experience in surgical patients and those patients in specialized critical care
units such as cardiovascular/cardiothoracic and neurological/neurosurgical
units. The ICU Liberation website provides many resources for these
specialized units (https://sccm.org/Education-Center/Clinical-
Resources/ICU-Liberation).
Before implementing an SAT protocol in an ICU or institution where SATs
are not regularly conducted, local stakeholders should consider the
conditions in their patient population that could make an SAT unsafe and
modify the safety criteria accordingly. Prior to implementing SATs
throughout the ICUs at Vanderbilt University Medical Center (VUMC), for
example, representatives from all of the institution’s ICUs jointly developed
a safety screen considered appropriate for the patient population at VUMC,
which includes medical, surgical, cardiac, neurological, and burn ICU
patients. This process resulted in the addition of several additional safety
screen criteria, including absence of open abdomen/chest, unsecured
cerebral aneurysm, unstable spine, difficult airway, volumetric diffusive
ventilation, surgical procedures requiring immobilization, or comfort care
orders. Similar experiences were noted in other ICU Liberation
Collaborative institutions whereby local units and leadership defined their
criteria collectively.
Daily, any eligible ICU patient receiving sedating medications is assessed
with the SAT safety screen. This applies to patients being sedated via
continuous infusion and those receiving intermittent boluses. A common
misconception is that SATs are indicated only in the setting of continuous
sedative infusions. SATs can and should be conducted for patients receiving
intermittent boluses of sedating medications, in which case the trial
involves delaying (or never giving) the next scheduled bolus. The timing of
the safety screen and the SAT itself should be determined by local
stakeholders, who can best identify the schedule that will be most beneficial
to patients and most practical for providers. Because many institutions are
in the habit of conducting SBTs in the morning before rounds, we
recommend scheduling SATs in the morning prior to SBTs. If local
practices make this time of day an inopportune time for awakening trials,
other options may be appropriate.
Upon passing the safety screen, a patient should undergo the SAT, which
consists of discontinuing medications given for sedation. Sedative infusions
should be held, as should any scheduled boluses, so that the patient’s ability
to tolerate being off sedation can be determined during the trial. Analgesics
that are being used for sedation (eg, fentanyl infusions) should be held as
well. Although some commonly used sedatives (eg, propofol or
dexmedetomidine) have short elimination half-lives, the pharmacokinetics
of these drugs are often altered during critical illness16 such that
discontinuing them abruptly during an SAT does not equate to a sudden
decrease in plasma concentrations. For this reason, we do not recommend
gradually lowering the dose (eg, by 50%) before proceeding to hold the
sedative, an approach that will delay the SAT.
Once sedatives are held, the SAT continues until the trial fails (the patient
demonstrates symptoms or signs indicating that sedatives should be
restarted) (Figure 1) or succeeds (the patient opens his or her eyes to verbal
stimuli or tolerates sedative interruption for ≥4 hours without exhibiting
failure criteria). In the ABC trial,3 837 (94%) of 895 SATs were passed, a
very high percentage attributed to the ability of the safety screen to identify
circumstances in which sedatives should not be held. Of the 58 (7%) trials
that failed, most ended with the patient exhibiting signs of anxiety,
agitation, or pain, which were promptly treated by restarting sedation.
Importantly, when sedatives are restarted after an SAT, half the previous
dose (whether via infusion or bolus) should be used initially since patients
often do not need as much sedative as they were previously receiving.
Subsequent Steps: Pass, Fail, or Repeat

The next steps taken after an SAT are no less important to improving
outcomes than the trial itself. As previously mentioned, patients for whom
the trial fails should have sedatives restarted at half their previous dose.
Then, the sedative doses should be adjusted as needed to achieve the
desired level of sedation ordered by the ICU team. As noted in multiple
clinical practice guidelines,8,17,18 light levels of sedation are associated with
better outcomes than moderate to deep sedation, and the Richmond
Agitation-Sedation Scale19 or the Sedation-Agitation Scale21 should be
used to monitor level of sedation. Pain should be adequately treated before
sedation is used, and nonbenzodiazepine sedatives (either propofol or
dexmedetomidine) should be used rather than benzodiazepines for general
sedation (with benzodiazepines being reserved for specific medical
indications, such as seizures). A detailed description of the evidence
supporting these recommendations is available elsewhere.8,17,18 Patients for
whom an SAT fails on one day should not be assumed to have the same
need for sedation on the following day; they should be reassessed with the
safety screen and, if they pass the safety screen, should undergo another
SAT, every day until sedation is successfully discontinued.
When a patient passes the SAT, two steps should be implemented. First, an
SBT safety screen should be used to determine whether an SBT can be
safety conducted. Second, patient management without sedatives should
continue until a provider notes signs or symptoms suggesting that sedatives
should be restarted. A common misunderstanding about SATs is that the
trial should be time limited, that is, that sedatives should be restarted once a
patient has become alert. To the contrary, the goal is not to temporarily
discontinue sedatives but rather to determine whether the patient can be
managed without the use of sedatives. If adequate analgesia is provided, a
majority of mechanically ventilated ICU patients can be successfully
managed without sedatives, as shown by Strom and colleagues22 in a
randomized trial where less than 20% of mechanically ventilated patients
managed with a “no sedation” protocol required continuous sedation (Table
3).
Table 3. Management and Outcomes of Patients in a Randomized Trial of a “No Sedation” Protocol
Variable No Sedationa
Controlb
P Value
(n = 55) (n = 58)
Received continuous sedation, n (%) 10 (18) 58 (100) 0.0001
Sedative doses, mg/kg
Propofol, per hour of infusion 0 [0-0.52] 0.77 [0.15-1.65] 0.0001
Midazolam, per hour of infusion 0 [0-0] 0 [0-0.02] <0.0001
Ventilator-free days, intubation to day 28 18.0 [0-24.1] 6.9 [0-20.5] 0.02
Hospital length of stay, days 34 [17-65] 58 [33-85] 0.004

aBoluses of intravenous morphine were given for pain, and intravenous haloperidol was given for
agitated delirium. If discomfort persisted despite these medications and nonpharmacological efforts
to address discomfort, continuous propofol was used for sedation.
bIn addition to boluses of intravenous morphine for pain, continuous propofol was used for sedation
for up to 48 hours, after which continuous midazolam was used. Spontaneous awakening trials were
performed daily, but sedatives were restarted after successful trials.
Data from Strom et al.22 Values are expressed as median [interquartile range] unless otherwise noted.
APPROACHING SPONTANEOUS BREATHING TRIALS
Eligibility, Safety Screen of the SBT

Any patient receiving mechanical ventilation can be screened and assessed
with the SBT safety screen. Generally, patients ventilated for more than 24
hours should be evaluated at least daily. Like the SAT, the SBT has two
phases. Every patient being considered for the SBT should be screened for
eligibility. Table 4 shows the components of the SBT safety screen. Review
of these safety screen components reduces the likelihood that the patient
will not tolerate the SBT. Although the components are straightforward,
providers might need to consider a patient’s underlying condition. For
example, the SBT might be performed at a higher Fio2 if the patient has a
chronic oxygenation disorder, such as underlying pulmonary fibrosis.
Although reduction in sedation is ideal, patients may still be considered for
SBTs while receiving drugs such as dexmedetomidine or anxiolytics.
Additionally, comatose patients with intact spontaneous breathing can
undergo the SBT.
Table 4. Criteria for a Spontaneous Breathing Trial
Safety Screen Eligibility Criteria

No airway pressure-release ventilation or high-frequency oscillatory ventilation
Capable of spontaneous breathing
Respiratory condition stable or improving
Fio2 ≤0.5 cm H2O
Positive end-expiratory pressure ≤8 cm H2O
Oxygen saturation >88
No arrythmia, no tachycardia
No agitation
Respiratory rate <35 breaths/min
Minute volume <5 L/min
No or minimal vasopressor use
Mean arterial pressure >60 mm Hg
Stable intracranial pressure in neurology patients
Failure Criteria
Respiratory rate >35 breaths/min for 5 minutes or <6 breaths/minute
Tidal volume <325 mL
Oxygen saturation <88% for 5 minutes
Heart rate >140 beats/min or increase 25% above baseline
Heart rate <60 beats/min
Acute arrhythmia
Systolic blood pressure increase 40 mm Hg above baseline
Sustained anxiety or agitation
Change in mental status
Change in intracranial pressure in neurology patients
The stability of the underlying respiratory problem is somewhat ambiguous.

Generally, if the patient is improving physiologically, then the patient’s
condition is resolving. If the patient reaches the thresholds of Fio2 less than
0.6 and PEEP less than 8 cm H2O, the condition may warrant an SBT.
Original work with SBTs used a T tube with the patient off the ventilator.4
Studies conducted since 2000 have used the ventilator to perform the SBT.
Using the ventilator has the advantages of enhanced monitoring of
parameters, adjustable alarms, and back-up mode in the event of prolonged
or frequent apneas. In 2017, the American Thoracic Society (ATS) and the
American College of Chest Physicians (ACCP) provided guidance in their
clinical practice guidelines.17 The guidelines recommended that for patients
ventilated more than 24 hours, the initial SBT should be performed with
inspiratory pressure augmentation of 5 to 8 cm H2O rather than a T tube.
Most institutions use 5 cm H2O PEEP and 5 cm H2O pressure support at the
same Fio2 that the patient is currently receiving or a slightly elevated Fio2.
The rationale for this practice is the concept that the endotracheal tube
poses additional resistance to airflow, and pressure support helps to
overcome that resistance. The smaller the endotracheal tube and the higher
the patient’s minute volume, the more resistance becomes a factor.
In 1991, Brochard et al23 demonstrated that pressure support reduces the
work of breathing significantly over a T tube and provides more
comfortable breaths. The added comfort may help reduce anxiety and
reduce the need for sedation. This is accomplished by allowing the patient
to have more control over the breath characteristics such as flow rate,
inspiratory time, and inspiration endpoint. For SBTs, a pressure support of 5
to 8 cm H2O is generally used.
Tubing compensation (TC) is used at some institutions to automatically

decrease pressure support, but data are still accumulating as to the overall
utility of TC. TC is also called automatic tubing compensation and tubing
resistance compensation depending on the ventilator manufacturer. This
feature is a type of automatic pressure that self-adjusts the amount of
physiological support throughout the respiratory cycle based on predefined
goals and machine algorithms. The ventilator uses the patient effort, internal
diameter, and type of tube (endotracheal or tracheostomy) to calculate the
pressure necessary to overcome resistance at the continually varying
flowrate. TC works on mandatory breaths as well as spontaneous breaths
and the expiratory phase as well as the inspiratory phase. During the
expiratory phase, TC allows pressure to decrease to the baseline more
rapidly by manipulating the active exhalation valve. TC is mostly used
during routine ventilation and weaning. The amount of the compensation
can be adjusted with the ventilator settings to make the work of breathing
easier or harder. This adds complexity to the use of TC. Several studies
have used TC instead of pressure support during the SBT.24 In a vigorously
breathing patient, TC will generate inspiratory pressures above 10 cm H2O.
Cohen et al26 compared TC versus continuous positive airway pressure
alone and found a tendency for more patients to pass the SBT with TC.
Other studies27 have found equal results for TC and pressure support or no
superiority of using TC over pressure support for SBTs. Although
performance of an SBT with PEEP and pressure augmentation (pressure
support or TC) is the recommended method by guidelines,17 these settings
make it easier for a patient to breathe and will mask a small number of
issues that could cause a patient to experience failure after extubation.
These settings do not replicate what the patient will experience after
removal of the tube.
Regardless of an institution’s definition of “minimal support” and the
method used, for some patients, the SBT safety screen may not reflect
underlying physiological derangements.
Logistics of the SBT

Ideally, the SBT is performed in conjunction and coordination with the
daily SAT. The ICU Liberation Collaborative highlighted the benefits of
ICU Liberation with both daily SATs and daily SBTs (the B element of
ABCDE). This element focuses on setting a time each day to stop sedative
medications, orient the patient to time and day, and conduct an SBT in an-
effort to liberate the patient from the ventilator. During the ICU Liberation
Collaborative, a common concern was whether the responsibility for
conducting the SAT-SBT would belong to the daytime or nighttime staff.
Many factors at each institution naturally affect the timing and performance
of the SAT-SBT. Workloads, nursing and respiratory staff, patient
availability, and access to the decision-maker for extubation all influence
the best timing of SAT-SBT.
Communication and coordination between caregivers are essential. All
caregivers involved (nurses, respiratory therapists, pharmacists, advanced
practice providers, and physicians) should be knowledgeable about patient
eligibility and the timing of the SAT-SBT. At the beginning of the shift a
discussion needs to be coordinated between nursing and respiratory care as
to when the SAT is scheduled followed by the SBT. In large ICUs with
multiple patients receiving ventilation, SAT and SBTs may not be able to be
performed on all patients at the same time. Coordination is essential to
manage the workloads. Institutions that have a clinical pharmacist available
have successfully used the pharmacist to assist in coordination of SBTs.29
SBTs are generally done once per day but can be performed on the same
patient multiple times if clinical conditions change. Patients who are out of
the unit for procedures may miss the standard time for an SBT. For
example, for a patient who receives dialysis in the morning, the SBT may
be performed later in the day.
Subsequent Steps: Pass, Fail, or Repeat

Assessing success of the SBT is important; criteria that define success or
failure (Table 4) should be readily available and understood by the staff.
Patients in whom the SBT fails generally resume ventilation at the settings
they had prior to the SBT. Some have argued that alternative modes such as
pressure support should be used instead of returning a patient to full
support; however, evidence is currently inconsistent. Providers should
investigate the reason for failure of the SBT and implement treatments to
improve the patient’s condition.
Patients who pass the SBT should be extubated as soon as possible. Patients
should be assessed for their ability to adequately cough and handle
secretions. Patients with excessive secretions and those who have required
suctioning more than every hour require caution. The ATS/ACCP
guidelines recommend that a cuff leak evaluation only be performed for
high-risk patients because false positive results are common and should not
delay extubation for low-risk patients.17 High-risk patients with no cuff leak
or insufficient cuff leak (<10%-15% or <115-130 mL) may be at risk for
postintubation stridor and reintubation, the ATS/ACCP recommendation is
that high-risk patients with an insufficient cuff leak be treated with steroids.
The ATS/ACCP guidelines also recommend that patients at high risk for
reintubation be considered for noninvasive ventilation. “At risk” includes
patients with congestive heart failure, chronic obstructive pulmonary
disease, identified or previous difficult intubation, and hypercapnia. Most
modern ventilators are equipped with a noninvasive mode that simply
requires the application of a mask to the existing tubing circuit, thus
eliminating the cost of a separate device.
SUMMARY
It has taken some time for institutions to broadly adopt the principles of the
ICU Liberation Bundle, but the process seems to be accelerating. Daily
assessments for awakening and breathing trials in mechanically ventilated
patients lie at the forefront of the bundle. Evidence is accumulating
regarding the overall impact of SATs and SBTs on important outcomes such
as duration of mechanical ventilation, ICU and hospital length of stay, and
costs. We expect this evidence to expand over the coming years as we learn
more about how the SAT and SBT work best in specialized units, general
units, different patient demographics, and different populations and health
systems across the globe. We will also continue to learn more through the
development of sedation strategies and medications as well as alternatives
to invasive mechanical ventilation for respiratory support.
REFERENCES
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sedative infusions in critically ill patients undergoing mechanical
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3. Girard TD, Kress JP, Fuchs BD, et al. Efficacy and safety of a paired
sedation and ventilator weaning protocol for mechanically ventilated
patients in intensive care (Awakening and Breathing Controlled trial):
a randomised controlled trial. Lancet. 2008;371:126-134.
4. Esteban A, Frutos F, Tobin MJ, et al. A comparison of four methods of
weaning patients from mechanical ventilation. Spanish Lung Failure
Collaborative Group. N Engl J Med. 1995;332:345-350.
5. Ely EW, Baker AM, Dunagan DP, et al. Effect on the duration of
mechanical ventilation on identifying patients capable of breathing
spontaneously. N Engl Med. 1996;335:1864-1869.
6. Ely EW, Bennett PA, Bowton DL, et al. Large scale implementation of
a respiratory therapist-driven protocol for ventilator weaning. Am J
Respir Crit Care Med. 1999;159:439-446.
7. MacIntyre NR, Cook DJ, Ely EW, et al. Evidence-based guidelines for
weaning and discontinuing ventilatory support: a collective task force
facilitated by the American College of Chest Physicians; the American
Association for Respiratory Care; and the American College of Critical
Care Medicine. Chest. 2001;120:375S-395S.
9. Hughes CG, Girard TD, Pandharipande PP. Daily sedation interruption
versus targeted light sedation strategies in ICU patients. Crit Care
Med. 2013;41:S39-S45.
10. Schmidt GA, Girard TD, Kress JP, et al. Liberation from mechanical
ventilation in critically ill adults: executive summary of an official
American College of Chest Physicians/American Thoracic Society
clinical practice guideline. Chest. 2017;151:160-165.
11. Ouellette DR, Patel S, Girard TD, et al. Liberation from mechanical
ventilation in critically ill adults: an official American College of
Chest Physicians/American Thoracic Society clinical practice
guideline: inspiratory pressure augmentation during spontaneous
breathing trials, protocols minimizing sedation, and noninvasive
ventilation immediately after extubation. Chest. 2017;151:166-180.
12. Balas MC, Vasilevskis EE, Olsen KM, et al. Effectiveness and safety
of the awakening and breathing coordination, delirium
monitoring/management, and early exercise/mobility bundle. Crit Care
Med. 2014;42:1024-1036.
13. Klompas M, Anderson D, Trick W, et al. The preventability of
ventilator-associated events: the CDC Prevention Epicenters Wake Up
and Breathe Collaborative. Am J Respir Crit Care Med. 2015;191:292-
301.
patients with the ABCDEF bundle: results of the ICU Liberation
Collaborative in over 15,000 adults. Crit Care Med. 2019;47:3-14.
15. Mehta S, Burry L, Cook D, et al. Daily sedation interruption in
mechanically ventilated critically ill patients cared for with a sedation
protocol: a randomized controlled trial. JAMA. 2012;308:1985-1992.
16. Masica AL, Girard TD, Wilkinson GR, et al. Clinical sedation scores
as indicators of sedative and analgesic drug exposure in intensive care
unit patients. Am J Geriatr Pharmacother. 2007;5:218-231.
17. Schmidt GA, Girard TD, Kress JP, et al. Official executive summary of
an American Thoracic Society/American College of Chest Physicians
clinical practice guideline: liberation from mechanical ventilation in
critically ill adults. Am J Respir Crit Care Med. 2017;195:115-119.
18. Devlin JW, Skrobik Y, Gelinas C, et al. Clinical practice guidelines for
Med. 2018;46:e825-e873.
19. Ely EW, Truman B, Shintani A, et al. Monitoring sedation status over
time in ICU patients: reliability and validity of the Richmond
Agitation-Sedation Scale (RASS). JAMA. 2003;289:2983-2991.
20. Sessler CN, Gosnell MS, Grap MJ, et al. The Richmond Agitation-
Sedation Scale: validity and reliability in adult intensive care unit
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21. Riker RR, Picard JT, Fraser GL. Prospective evaluation of the
Sedation-Agitation Scale for adult critically ill patients. Crit Care
Med. 1999;27:1325-1329.
22. Strom T, Martinussen T, Toft P. A protocol of no sedation for critically
ill patients receiving mechanical ventilation: a randomised trial.
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23. Brochard L, Rua F, Lorino H, et al. Inspiratory pressure support
compensates for the additional work of breathing caused by the
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24. Haberthur C, Mols G, Elsasser S, et al. Extubation after breathing trials
with automatic tube compensation, T-tube or pressure support
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25. Figueroa-Casas JB, Montoya R, Arzabala A, et al. Comparison
between automatic tube compensation and continuous positive airway
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26. Cohen JD, Shapiro M, Grozovski E. Extubation outcome following a
spontaneous breathing trial with automatic tube compensation versus
continuous positive airway pressure. Crit Care Med. 2006;34:682-686
27. Esteban A, Alia I, Tobin M, et al. Effect of spontaneous breathing trial
duration on outcome of attempts to discontinue mechanical ventilation.
Am J Resp Crit Care Med. 1999;159:512-518.
28. Figueroa-Casas JB, Connery SM, Montoya R. Changes in breathing
variables during a 30-minute spontaneous breathing trial. Respir Care.
2015;60:155-161.
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quality improvement: coordinating spontaneous awakening and
breathing trials. Ann Pharmacother. 2015;49:883-891.
Choice of Analgesia and Sedation
Joanna L. Stollings, PharmD, FCCM, Paul M. Szumita, PharmD, FCCM,
and John W. Devlin, PharmD, MCCM
Objectives
Understand the importance of using a pain-first, assessment-driven

management approach.
Apply a multimodal analgesia strategy to improve pain control and
reduce opioid use, particularly in surgical patients.
Individualize analgesic management plans in different adult ICU
subpopulations.
Consistently apply the Richmond Agitation-Sedation Scale and Sedation-
Agitation Scale to evaluate level of arousal and maintain sedation at the
desired goal.
Construct an analgesia and sedation strategy for mechanically ventilated
adults consistent with 2018 PADIS recommendations.
Apply strategies to reduce opioid and sedative use during post-ICU
transitions of care.
Key words: pain, sedation, assessment, opioids, acetaminophen, ketamine,

gabapentin, pregabalin, dexmedetomidine, lorazepam, midazolam, propofol
Maintaining patients in a comfortable and calm state is an important goal of ICU care,
and analgesics and sedatives are often effective in reaching these goals. However,
these same medications are also associated with important safety concerns, particularly
when their use leads to excessive sedation or unexpected adverse effects, especially
when the medications may no longer be clinically necessary. Inappropriate analgesic
and sedative use can hinder patient communication, pain and delirium assessment,
ventilator liberation, and mobility efforts. This chapter focuses on recommendations
from the 2018 Society of Critical Care Medicine (SCCM) PADIS (Pain,
Agitation/Sedation, Delirium, Immobility, and Sleep Disruption) guidelines and
evidence from current literature to provide ICU clinicians with strategies to optimize
the choice of analgesics and sedatives in critically ill adults.
ANALGESIA
Assessment-Driven Protocols
As outlined in Chapter 2, all critically ill adults should be routinely evaluated for
pain, and analgesia should be considered when pain is identified. The 2018 SCCM
PADIS guidelines specifically note that “management of pain for adult intensive care
unit (ICU) patients should be guided by routine pain assessment and pain should be
treated before a sedative agent is considered.”1 The PADIS guidelines also
conditionally recommend the use of an assessment-driven, protocol-based, stepwise
approach for pain management in critically ill adults given that this practice will
improve pain scores, reduce sedative use, improve time spent at the target sedation
goal, allow earlier liberation from mechanical ventilation, reduce ICU and hospital
length of stay, and decrease mortality rates. This approach places increased emphasis
on intravenous (IV) bolus therapy and decreased use of continuous infusions.
Importantly, such an approach did not result in increased opioid-related adverse drug
effects (ORADE) nor in overall opioid consumption.2-6 Pain associated with patient
activity and procedures known to cause pain should likewise be assessed and treated
through targeted, preemptive analgesic administration.1
Analgosedation
Analgosedation is defined as either analgesia-first sedation (ie, an analgesic, usually an
opioid, is used before a sedative to reach the sedation goal) or analgesia-based sedation
(ie, an analgesic, usually an opioid, is used instead of a sedative to reach the sedative
goal).8-11 Analgesia-based sedation takes advantage of the sedative properties of
opioids to optimize mechanical ventilation. Until recently, analgesia-based sedation
had been evaluated in a controlled fashion in European ICUs only, where ICU
practices may be different than in the United States and where remifentanil (an ultra-
short-acting opioid) use is prevalent.12 A recent randomized controlled trial (RCT) in
the United States found that although analgesia-based sedation using fentanyl
(compared with continuous gabaminergic sedation, such as benzodiazepines or
propofol) achieved pain and sedation goals equally, it increased bedside nursing
workload and did not reduce days on mechanical ventilation or days without
delirium.12 Although not well-evaluated in RCTs, concerns exist that analgesia-based
sedation may accentuate ORADEs. Analgesia-based sedation may be better suited for
surgical patients than medical patients; it should be used with caution in patients
requiring continuous gabaminergic sedation (eg, those with acute alcohol withdrawal,
neuromuscular blockade, status epilepticus, or refractory elevated intracranial
pressure).
Although important questions remain about the role for analgesia-based sedation, ICU
clinicians should consider using a protocolized, analgesia-first approach on a routine
basis in their patients. Efforts should be made at the local level (ie, individual ICU or
hospital) to ensure that pain is routinely assessed in both communicative and
noncommunicative patients by using the appropriate validated tool, that all
assessments are documented, and that pain is treated before sedative administration is
considered. Potential barriers to this practice should be considered.1
Opioid Choice, Route of Administration, and Dosing

Recommendations for opioid choice, route of administration, and dosing have not
changed from the 2013 SCCM Pain, Agitation, and Delirium (PAD) guidelines.1
Opioid regimens should be individualized to patients; a number of different factors
need to be considered (Table 1). The pharmacokinetic and pharmacodynamic (PK/PD)
properties of opioids differ among the opioids most commonly administered in the
ICU (ie, fentanyl, hydromorphone, morphine, and remifentanil). Fentanyl is highly
distributed to fat, and thus its administration often results in unpredictable serum
concentration; its clearance is lower in patients with severe liver disease or congestive
heart failure.13 In patients with renal dysfunction, morphine’s active morphine 6-
glucuronide metabolite will accumulate, increasing the risk for seizures and
myoclonus.15 Although remifentanil has a short half-life and thus is more easily
titrated, the tachyphylaxis and hyperalgesia associated with prolonged infusions limit
the use of remifentanil in the ICU to only short durations.16
Table 1. Comparison of Opioids
Medication Time Half- Prolonged Clinical Primary Prolonged Practical Considerations

to life Effect Due to Metabolic Clinical Effect
Onset, Context-Sensitive Pathway Due to Organ
min Half-life Failure
Fentanyl 1 2- Yes: significant N-dealkylation Hepatic Requires phase 1
4 h CYP450 3A4/5 metabolism; therefore, a
prolonged clinical effect
with inhibitors of CYP450
3A4/5
Accumulation risk in
obese patients
Rare, potentially life-
threatening increased risk
of serotonin syndrome and
chest wall rigidity
Hydromorphone 5-10 2-3 Not applicable Glucuronidation Hepatic Therapeutic substitute for
h fentanyl or morphine in
patients with hepatic or
renal dysfunction
Morphine 5-10 3-4 Not applicable Glucuronidation Renal and Histamine release—
h hepatic leading to hypotension
Metabolite accumulation in
renal dysfunction leading
to central nervous system
toxicity
Cholecystitis
Remifentanil 1-3 3-10 Yes: minor Hydrolysis by Renal: minimal High risk of opioid-induced
min plasma and tachyphylaxis
tissue High risk of opioid-induced
esterases hyperalgesia
May increase ammonia
levels
Accumulation in obese
patients, suggest ideal
body weight dosing
Clinicians might consider rotating opioids for ICU patients who require prolonged
infusions, in an effort to reduce accumulation and toxicity and optimize response.18
The conversion from continuous fentanyl to continuous hydromorphone in one
critically ill cohort led to improved ventilatory compliance, reduced sedative exposure,
and favorable PK/PD properties, although a prospective analysis is needed to evaluate
clinical outcomes.19 Prolonged exposure to opioids in the ICU setting may lead to
tolerance, dependence, and/or withdrawal.20 Fentanyl patches, patient-controlled
analgesia, and enteral methadone have each been shown to effectively wean critically
ill adults off opioid infusions by maintaining pain control and minimizing withdrawal
effects.21-24
The approach to pain management in ICU patients with opioid use disorder, including
patients managed with methadone or buprenorphine, is complex given that these
patients may be more susceptible to pain but also have a higher tolerance to opioid
therapy.25 Management strategies may include using nonopioid analgesics like
ketamine in a multimodal approach; these strategies include targeting opioid analgesics
for only short periods when acute pain is present, using methadone for chronic ICU
pain, and ensuring that partial opioid antagonists like buprenorphine are restarted when
opioid therapy is stopped.26 For opioid-abstinent patients with opioid use disorder who
do not want to receive opioid therapy during their ICU stay, the increasing literature
focused on opioid-sparing or opioid-free pain management after surgery should be
considered.27
Multimodal Analgesia
The goal of multimodal analgesia, defined as the combined use of analgesics working
by different mechanisms and at different nervous system sites, is to produce a degree
of analgesia that is greater than that which can be achieved with a single analgesic
(usually an opioid). Given that many post-analgesic safety concerns are dose-related,
the administration of lower analgesic dose may reduce analgesic-associated adverse
events. A multimodal analgesic approach is increasingly being used in the
perioperative setting (eg, as part of Enhanced Recovery after Surgery [ERAS]
protocols) and was rigorously evaluated in the PADIS guidelines.1 In an era of ever-
increasing concern about the overuse of opioids during acute hospitalization and their
potential role in escalating posthospital opioid use disorder, multimodal analgesic
efforts in the ICU have been focused on reducing opioid exposure.
Among the 6 agents or classes of nonopioid analgesics evaluated in the PADIS
guidelines as adjuvants for opioids when treating pain, only 4 agents were
recommended (acetaminophen, ketamine, neuropathic agents, and nefopam).1
Nefopam, which received a conditional recommendation in PADIS as an adjuvant for
opioids, is widely used in Europe. However, nefopam is not currently available in the
United States and is not discussed further in this chapter.
The conditional recommendation to use acetaminophen is based on 2 small surgical
trials that collectively showed a reduction in pain and a reduction in the amount of
opioids needed.33 A recent randomized controlled trial entitled, Effect of Intravenous
Acetaminophen Vs Placebo Combined with Propofol or Dexmedetomidine on
Postoperative Delirium Among Older Patients Following Cardiac Surgery
(DEXACET) showed that the administration of scheduled IV acetaminophen (vs
placebo) in patients undergoing cardiac surgery was associated with reduced delirium,
a shorter length of ICU stay, and less breakthrough opioid use.35 The route of
administration (eg, IV, liquid, tablet, or rectal) should be based on individualized
patient assessment and formulary status. Acetaminophen should be used with caution
in patients with hepatic dysfunction and may be associated with hepatic toxicities if
given at higher than recommended dosing. The IV or rectal route may be optimal in a
patient who does not have reliable oral or enteral access or is vomiting. The IV
formulation has been associated with hypotension and thus should be used with care in
patients who are hemodynamically unstable.36 IV acetaminophen is not available in all
countries and has a high acquisition cost in some countries, often limiting its formulary
status.
Although ketamine is widely used in non-ICU perioperative settings as a multimodal
analgesic based on the results of several controlled studies,38 only a conditional
recommendation was made in 2018 PADIS to use ketamine in postsurgical adults in
the ICU given that only 1 small RCT has evaluated its use in this setting.40
Importantly, the recommendation limited the use of ketamine to low doses. Although
an increasing number of observational trials have evaluated ketamine as an adjunct
sedative in the ICU, its role as an analgesic requires additional research.41
Hallucinations, tachycardia, and emergence delirium are common dose-related safety
concerns.
The PADIS guidelines make 2 recommendations for the use of adjunctive neuropathic
analgesics (eg, gabapentin, carbamazepine, and pregabalin): (1) a strong
recommendation to use neuropathic pain medication with opioids for neuropathic pain
management in critically ill adults and (2) a conditional recommendation to use these
medications with opioids for pain management in ICU adults after cardiovascular-
surgery.1 These post–cardiovascular surgery trials demonstrated a reduction in opioid
consumption with pregabalin use but reported no other differences.43 Safety concerns
with these medications include oversedation, and their use in patients with liver and
renal disease.
Regional analgesia, such as neuraxial analgesia, nerve blocks, epidural blocks, and
peripheral nerve blocks, is routinely used in the non-ICU perioperative setting. These
techniques, although not formally evaluated in PADIS, likely have a place in ICU
practice when multimodal analgesic approaches are being constructed despite the
current limited evidence supporting their use in the ICU.
The PADIS guidelines conditionally recommend against the use of IV lidocaine
infusions, given that neurological, hemorrhagic, nephrotoxic, and cardiac safety
concerns associated with its use may be greater in the critically ill. The routine use of
nonsteroidal anti-inflammatory drugs (NSAIDS) are also not recommended in
critically ill adults given concerns about renal toxicity and bleeding. These safety
concerns are magnified with increasing dose frequency, and given overall lack of
evidence supporting clinical efficacy, we do not recommend the routine use of these
medications at this time.1,45,46
Procedural Pain
Procedural pain is common in critically ill adults.47 Table 2 highlights the
pharmacological interventions considered in 2018 PADIS. When opioids are used for
procedural pain, the lowest, most effective dose should be administered given that
most opioid safety concerns are dose-related. The administration of a single IV,
enteral, or oral dose of an NSAID before an ICU procedure is conditionally
recommended. Opioid or NSAID administration should be timed so that maximum
serum drug concentration is achieved just before the procedure occurs. Conditional
recommendations against the use of local and inhaled anesthetics were made given a
current lack of evidence demonstrating efficacy and concerns about safety. The use of
nonpharmacological interventions, such as massage, music, cold therapy, and
relaxation techniques, before procedures is supported by PADIS conditional
recommendations; these techniques are discussed in Chapter 2.
Table 2. Nonopioid Analgesics Evaluated in the PADIS Guidelines as an Analgesic Adjunct to Opioids for Treatment of Pain or
to Prevent Procedural Pain
Medication/Medication 2018 PADIS

Primary Efficacy Clinically Relevant Practical
Class Recommendation Results From

Safety Concerns
Considerations
ICU Trials in the ICU
Recommended for the Treatment of Pain
Acetaminophen Suggest using as an Decrease in Liver toxicity May be given by
adjunct to an opioid to pain intensity Nausea and enteral, rectal, or IV
decrease pain intensity Decrease in vomiting route.
and opioid consumption opioid Hypotension
for pain management in consumption (IV)
critically ill adults
(conditional
recommendation, very
low quality of evidence).
Ketamine Suggest using low-dose Decrease in opioid Nausea Use with caution
ketamine (0.5 mg/kg IV consumption Delirium in patients with
push × 1 followed by 1- Hallucinations hypertension.
to 2-μg/kg/min infusion) Pruritus Monitor for
as an adjunct to opioid Sedation emergence
therapy when seeking to Tachycardia delirium.
reduce opioid Hypertension Monitor for
consumption in Hypotension excess
postsurgical adults Respiratory secretions.
admitted to the ICU depression (high Has direct
(conditional dose) negative cardiac
recommendation, very Increase in inotropic effect,
low quality of evidence). salivary and typically masked
tracheobronchial by direct
mucus stimulation of
production the central
nervous system.
Critically ill
patients who are
catecholamine
depleted may
experience
hypotension and
decreased
cardiac output.
May increase
intracranial
pressure.
Carbamazepine, Recommend Reduction in Somnolence Carbamazepine:

gabapentin, pregabalin using a pain intensity Dizziness many drug
neuropathic pain for patients Atrial fibrillation interactions.
medication (eg, with Guillain- Edema Use with caution
gabapentin, Barre Dose in patients with
carbamazepine, syndrome adjustment for hepatic disease.
pregabalin) with Reduction in renal Gabapentin and
opioids for opioid dysfunction pregabalin: use
neuropathic pain exposure in with caution in
management in cardiovascular (gabapentin, elderly patients
critically ill adults surgery pregabalin) and patient with
(strong renal
recommendation, dysfunction due
moderate quality to risk of
of evidence). increased
Suggest using a somnolence and
neuropathic pain dizziness.
medication (eg,
gabapentin,
carbamazepine,
pregabalin) with
opioids for pain
management in
ICU adults after
cardiovascular
surgery
(conditional
recommendation,
low quality of
evidence).
Not Recommended for the Treatment of Pain

IV lidocaine infusion Suggest not routinely No difference in any Hypotension Serum level monitoring
using IV lidocaine as an critical outcome Bradycardia is warranted for use in
adjunct to opioid therapy Arrythmia patients with hepatic-
for pain management in Central nervous renal dysfunction and
critically ill adults system toxicity for prolonged infusions
(conditional Seizure (>24 h).
recommendation, low Caution in
quality of evidence). hepatic and
renal
dysfunction and
cardiovascular
disease
NSAID Suggest not routinely Adjunctive: minimal Gastrointestinal Use with caution in
using a cyclooxygenase reduction in opioid toxicity patients with bleeding
1–selective NSAID as consumption Renal failure risk, heart failure, renal
an adjunct to opioid Bleeding dysfunction, low weight,
therapy for pain Cardiovascular elderly.
management in critically events
ill adults (conditional Nausea and
recommendation, low vomiting
quality of evidence). Caution in
hepatic and
renal
dysfunction and
heart failure
Contraindicated
in coronary
artery bypass
graft surgery
(black box)
Recommended for the Prevention of Procedural Pain
NSAID Suggest using an Procedural: similar See above See above
NSAID administered IV, outcomes to opioids
orally, or rectally as an
alternative to opioids for
pain management
during discrete and
infrequent procedures in
critically ill adults
(conditional
recommendation, low
quality of evidence).
Not Recommended for the Prevention of Procedural Pain

Local Suggest not using either Limited data currently Minimal Many variables to
anesthetics/nitrous local analgesia or available systemic consider: choice of
oxide nitrous oxide for pain absorption local anesthetic,
management during Precaution for amount of anesthetic
chest tube removal in allergic used, expertise of the
critically ill adults reactions operator.
(conditional
recommendation, low
quality of evidence).
Volatile anesthetics Recommend not using No randomized Nausea Typically not practical in
inhaled volatile controlled trials Malignant the critical care setting.
anesthetics for comparing volatile hyperthermia
procedural pain anesthetics versus a Precaution in
management in critically standard controlled cardiovascular
ill adults (strong intervention disease
recommendation, very
low quality of evidence).
Abbreviation: NSAID, nonsteroidal anti-inflammatory drug.
Pain Management in Special ICU Populations

Burn Injured
Patients admitted to the ICU for the management of burn injuries typically suffer
substantial pain.48-50 These patients often require high-dose opioids; however, the
PK/PD alterations seen in this population can make pain management challenging.
Pregabalin and ketamine are options to consider in order to reduce opioid consumption
and optimize the treatment of neuropathic pain, prevalent in the burn injury
population.51
ARDS and ECMO

Opioids, given their potent respiratory depressant properties, are usually a mandatory
part of continuous sedative therapy to optimize ventilator compliance in patients with
acute respiratory distress syndrome (ARDS). The higher doses needed to reach these
non-pain-related goals often lead to a higher rate of ORADEs. Opioid rotation should
be considered if high-dose and/or prolonged management with continuous opioids is
required. Patients requiring extracorporeal membrane oxygenation (ECMO) may
require higher doses of opioids based on potential drug binding to the EMCO circuit
and augmented ECMO clearance; an increase in opioid dose requirements in this
setting is not universally seen.53-55
Neurological Injury
Analgesia-based sedation with remifentanil may be a preferred option for brain-injured
patients given that the ultra-short half-life of this agent may facilitate wakefulness
when neurological assessment is required.56 Among patients with high intracranial
pressure, the effects of opioids on intracranial pressure are variable; therefore, close
monitoring is warranted when opioids are used in this population.57
Chronic Pain Syndromes and Hyperalgesia

Patient-specific multimodal analgesia focused on decreasing the use of opioids is
important when managing ICU adults with chronic pain syndromes and
hyperalgesia.58 Ketamine may be warranted in these patients to counteract opioid-
induced hyperalgesia effects.59
SEDATION
Sedatives are commonly administered in the ICU to improve safety, decrease both
anxiety and patient recall of distressing ICU experiences, improve ventilator tolerance,
decrease the hyperadrenergic response, and treat substance withdrawal.7,60,61 The use
of sedatives in this setting is often associated with unwanted outcomes including
respiratory depression, hemodynamic instability, greater delirium, and an increased
time on mechanical ventilation that can prolong ICU length of stay.62
Sedation Monitoring
The 2013 PAD guidelines recommend the Sedation-Agitation Scale (SAS) and the
Richmond Agitation-Sedation Scale (RASS) as the most valid and reliable tools for
assessing quality and depth of sedation in critically ill adults (Tables 3 and 4).7,64,65
This recommendation was based on an extensive evaluation of the available
psychometric literature for 10 different ICU sedation tools. Objective sedation
monitoring (eg, bispectral index) is best suited for sedation titration during deep
sedation or neuromuscular blockade when SAS or RASS cannot be used.1
Table 3. Riker Sedation-Agitation Scale
Score Term Descriptor
7 Dangerous Pulls at endotracheal tube, tries to remove catheters, climbs over bedrail, strikes at staff,
agitation thrashes side to side
6 Very agitated Requires restraint and frequent verbal reminding of limits, bites endotracheal tube
5 Agitated Anxious or physically agitated, calms to verbal instructions
4 Calm and Calm, easily arousable, follows commands

cooperative
3 Sedated Difficult to arouse but awakens to verbal stimuli or gentle shaking, follows simple commends but
drifts off again
2 Very sedated Arouses to physical stimuli but does not communicate or follow commands, may move
spontaneously
1 Unarousable Minimal or no response to noxious stimuli, does not communicate or follow commands
Data taken from Riker RR, Picard JT, Fraser GL. Prospective evaluation of the Sedation-Agitation Scale for adult
critically ill patients. Crit Care Med. 1999;27:1325–1329.
Table 4. Richmond Agitation-Sedation Scale
Scale Label Description

+4 Combative Combative, violent, poses immediate danger to staff
+3 Very agitated Pulls to remove tubes or catheters; aggressive
+2 Agitated Frequent nonpurposeful movement, fights ventilator
+1 Restless Anxious, apprehensive movements; not aggressive
0 Alert and calm Spontaneously pays attention to caregiver
−1 Drowsy Not fully alert but has sustained awakening to voice (eye opening and contact >10 s)
−2 Light sedation Briefly awakens to voice (eyes open and contact <10 s)
−3 Moderate sedation Movement or eye opening to voice (no eye contact)
−4 Deep sedation No response to voice, but movement or eye opening to physical stimulation
−5 Unarousable No response to voice or physical stimulation
Data taken from Sessler CN, Gosnell MS, Grap MJ, et al. The Richmond Agitation-Sedation Scale: Validity and
reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002;166:1338-1344.
Level of sedation should be evaluated in the ICU every 2 to 4 hours and before
delirium is assessed. Education regarding sedation assessment and spot checking the
reliability of clinicians to conduct accurate RASS or SAS assessments remain an
important part of ICU quality improvement efforts even when sedation assessment is a
well-established practice. As outlined in Chapter 5, delirium assessment should be
conducted when a patient is maximally awake (eg, after a spontaneous awakening trial
[SAT]) to distinguish between persistent delirium and rapidly reversible, sedation-
related delirium.66 As outlined in Chapter 8, it is often reasonable to withhold bedside
sedation assessments at night for patients who are persistently at their sedation goal. In
contrast, critically ill patients who require a deep level of sedation or frequent
neurological assessments, or who have demonstrated poorly controlled pain during the
day or evening, should undergo evaluations for level of arousal throughout the night.67
Sedation Goal
In critically ill adults who require sedation, the PADIS guidelines recommend
maintaining a light level of sedation (RASS –2 to 0; SAS 3 to 4) rather than deep
sedation (unless light sedation is clinically contraindicated). The evidence to support
this recommendation comes from 8 RCTs demonstrating that light sedation is
associated with a shorter time to extubation and reduced tracheostomy rate.1 Although
this pooled analysis did not find light sedation to be associated with reduced delirium,
a recent cohort study that found sedation intensity (sum of negative RASS assessments
divided by number of assessments) was a predictor for delirium occurrence.69 Even
early deep sedation is associated with increased hospital and 6-month mortality.70
Light sedation will promote interaction between patients and both their clinicians and
families. Communication regarding care decisions will be facilitated, pain and delirium
assessments may be more robust, patient-perceived sleep quality can to be assessed,
and early mobilization efforts will be more effective. Chapter 3 describes the use of
SATs to promote light sedation. Many critically ill patients do not have daily SATs
despite the important benefits associated with light sedation.71-74 The use of sedation
protocols, particularly those that require regular sedative titration every 2 to 4 hours to
reach the defined sedative goal, and where SAT use is encouraged, have consistently
been shown to facilitate faster liberation from mechanical ventilation, reduce ICU
length of stay, and decrease tracheostomy rates.3 Sedation protocols should be used on
a 24/7 basis to avoid over sedating patients at night.85 If clinically indicated, a patient’s
sedation should be titrated more frequently than every 2 to 4 hours.
An ICU interprofessional team applying the ICU Liberation Bundle will help promote
ICU patient wakefulness. In this context, additional effective strategies for minimizing
sedation include didactic instruction, training videos, online resources (eg,
www.icudelirum.org or www.iculiberation.org), case-based scenarios, pocket cards,
posters, flyers, and one-on-one teaching accompanied by assessment to ensure correct
performance. Sedation minimization strategies should be discussed on
interprofessional rounds daily, and compliance with sedation minimization strategies
such as SATs should be documented in the electronic medical record. Reasons for
noncompliance should be carefully evaluated; additional efforts focused on key ICU
stakeholder groups (eg, nurses who work primarily at night) should be considered.86
Sedative Choice
Many mechanically ventilated adults, even those with ARDS, can be safely managed
in the ICU without continuous IV sedation.88 Even when continuous sedation is
initiated, there is no evidence to support a deep sedation goal in most patients.89 As
outlined above in the analgosedation section above, analgesics should be administered
to treat pain and the potential associated agitation before sedatives are considered.8
Sedatives should be reserved for patients who are anxious and/or agitated and for
whom ICU goals of care, including mechanical ventilation, cannot be safely delivered
without sedation. Sedatives are also routinely required for patients who are in a
withdrawal state, patients with status epilepticus, those with increased intracranial
pressure, or those who require neuromuscular blockers.60 The properties of the ideal
sedative include a rapid onset and rapid offset, a predictable dose-response
relationship, easy administration, a lack of drug accumulation, few side effects,
minimal drug interactions, cost-effectiveness, and the ability to promote natural
sleep.91-93 The PADIS guidelines suggest using either propofol or dexmedetomidine
over a benzodiazepine (ie, midazolam or lorazepam) for sedation in critically ill,
mechanically ventilated adults regardless of whether they are undergoing cardiac
surgery (condition recommendation, low quality of evidence).1
Propofol Versus a Benzodiazepine

A review of available RCTs comparing propofol versus a benzodiazepine among
mechanically ventilated adults not undergoing cardiac surgery found that the use of
propofol (vs a benzodiazepine) was associated with an average of 7.2 fewer hours to
reach light sedation (n = 7 trials) and an average of 11.6 fewer hours to extubation (n =
9 trials). The only trial that evaluated delirium in patients receiving propofol versus a
benzodiazepine found no difference. Although propofol was associated with a small
increase in self-extubation, the clinical significance of this result remains unclear
because the need for reintubation was not reported. Overall, the PADIS panel judged
that the beneficial effects of propofol (over a benzodiazepine) outweighed any
limitations.
Dexmedetomidine Versus a Benzodiazepine

Among 5 published RCTs comparing dexmedetomidine with benzodiazepines in
mechanically ventilated adults not undergoing cardiac surgery, pooled results did not
show a significant benefit of dexmedetomidine compared with a benzodiazepine for
time to extubation, length of ICU stay, or risk for delirium.1 Studies differed in terms
of whether an SAT was used and how patients were weaned. However, the largest RCT
and the study with the lowest risk of bias, the Safety and Efficacy of
Dexmedetomidine Compared With Midazolam (SEDCOM) study, reported significant
reductions in time to extubation (1.9 days) and delirium (29% reduction) with
dexmedetomidine use and had an important influence on how the PADIS panel
developed its conditional recommendation to use dexmedetomidine rather than a
benzodiazepine.62 Although both the SEDCOM and the Effect of Sedation with
Dexmedetomidine vs. Lorazepam on Brain Dysfunction in Mechanically Ventilated
Patients (MENDS) trials94 reported more bradycardia with dexmedetomidine, neither
study reported that an intervention was needed to treat the bradycardia (other than
reducing or holding dexmedetomidine).
Propofol Versus Dexmedetomidine

Three published RCTs compared propofol and dexmedetomidine for sedation in
mechanically ventilated adults not undergoing cardiac surgery and found no difference
in time to extubation.1 In the largest of these trials, Propofol vs Dexmedetomidine
(PRODEX),95 the proportion of time at target RASS (0, –3) without rescue therapy
was identical between the propofol and dexmedetomidine groups (both 65%). Patients’
ability to communicate discomfort was better in the dexmedetomidine group. Rates of
hypotension and bradycardia were similar between the 2 groups. Critical illness
polyneuropathy was more common in the propofol group (11 patients vs 2 patients; P
< 0.02). The composite outcome of agitation, anxiety, and delirium occurred more
frequently with propofol (29% vs 18%; P = 0.008). MENDS II is a recently finished
randomized, multicenter trial involving mechanically ventilated adults with sepsis that
compared the use of dexmedetomidine versus propofol on days spent free of delirium
and coma in the 14 days after randomization.
Dexmedetomidine Versus Placebo

Three RCTs have compared dexmedetomidine versus placebo in critically ill adults.97-
99 The Dexmedetomidine to Lessen ICU Agitation (DAHLIA) trial evaluated the role
of dexmedetomidine as a treatment for agitation precluding extubation in mechanically
ventilated adults with delirium.97 The study, which screened 21,500 intubated patients
across 15 ICUs to enroll 71 patients and was terminated early by the funder, found that
dexmedetomidine was associated with a small but significant reduction in ventilator-
free hours in the 7 days after randomization; however, neither ICU or hospital length
of study nor patient disposition at hospital discharge differed between the 2 groups.
The results of this trial led the PADIS panel to suggest using dexmedetomidine for
delirium in mechanically ventilated adults when agitation precludes weaning and/or
extubation (conditional recommendation, low quality of evidence).1
The Dexmedetomidine for Sepsis in ICU Randomized Evaluation Trial (DESIRE) was
an open-label, multicenter, randomized clinical trial conducted in 8 ICUs in Japan in
which 201 patients with sepsis were randomized to receive either dexmedetomidine or
placebo.98 Ventilator-free days and mortality at 28 days were not different between the
dexmedetomidine and placebo groups. The Sedation Practice in Intensive Care
Evaluation (SPICE III), randomized, open-label trial compared dexmedetomidine
versus usual sedation care (ie, propofol and/or midazolam) in nearly 4,000 critically ill
adults and found that 90-day mortality was identical between the dexmedetomidine
(29.1%) and usual care (29.1%) groups. However, in the first 2 days after
randomization, 64% of the dexmedetomidine patients received propofol and/or
midazolam, and the proportion of those who reached the target RASS score of –2 to +1
during this period was low in each group (dexmedetomidine, 56.6%; usual care,
51.8%).99 Because bradycardia and hypotension were common in the
dexmedetomidine-treated group, the early use of dexmedetomidine to maintain light
sedation in critically ill adults requiring continuous sedation requires further
investigation before it is adopted in clinical practice.
Ketamine
Ketamine administration for non-pain-related agitation in mechanically ventilated
adults is increasing. Only small, heterogeneous studies have attempted to evaluate the
role of ketamine in this population.41 Although the use of ketamine is associated with
reduced propofol (and its potential side effects), the effects of ketamine on mortality,
vasopressor use, hospital length of stay, and level of sedation remain unclear.
Sedation Management in Specialized ICU Populations

Patients Requiring Deep Sedation
Propofol or a benzodiazepine rather than dexmedetomidine should be considered when
deep sedation is required. Because propofol generally should not be administered at
rate exceeding 60 to 80 μg/kg/min given potential concerns about hypertriglyceridemia
and propofol-induced infusion syndrome, a benzodiazepine infusion may be required.
The pharmacokinetic, dosing, and safety profiles of the benzodiazepines (eg,
diazepam, lorazepam, and midazolam) compared with dexmedetomidine and propofol
are highlighted in Table 5.
Table 5. Comparison of Sedatives
Medication Time Half- Primary Active Loading Maintenance Adverse Effects

to life, Metabolic Metabolite Dose (IV) Dosing (IV)
Onset, h Pathway
min
Propofol 1-2 1.5- Hydroxylation No 5 5-50 μg/kg/min Hypotension
12.4 and μg/kg/min Hypertriglyceridemia
glucuronidation Pancreatitis
(CYP2B6 over
Propofol-induced
substrate) 5 min infusion syndrome
Dexmedetomidine 5-10 1.8- Hydroxylation No 1 μg/kg 0.2-0.7 μg/kg/h Bradycardia

3.1 and over
Hypotension
glucuronidation 10 min
(CYP2A6
substrate)
Lorazepam 5-20 10- Glucuronidation No 0.02-

0.02-0.06 Respiratory
20 0.04 mg/kg every 2- depression
mg/kg 6 h as needed Propylene glycol–
(≤2 mg) or 0.01-0.1 related acidosis
mg/kg/h (≤10 Nephrotoxicity
mg/h)
Midazolam 2-5 3-12 Hydroxylation Yes 0.01-

0.02-
Respiratory
(CYP3A4/5 0.05 0.1 mg/kg/h depression
substrate) mg/kg Hypotension
(over
several
minutes)
Diazepam 2-5 20- N-demethylation Yes 5-10 mg 0.03-0.1 mg/kg Respiratory

50 and every 0.5-6 h depression
hydroxylation as needed Hypotension
(CYP3A4, 2C19 Phlebitis
substrate)
Continuous Neuromuscular Blocker Therapy

The Clinical Practice Guidelines for Sustained Neuromuscular Blockade in the Adult
Critically Ill state that optimal clinical practice requires administration of analgesic and
sedative drugs prior to and during neuromuscular blockade with the goal of achieving
deep sedation.99 Given dexmedetomidine’s lack of amnestic properties, propofol (or a
benzodiazepine) is the sedative of choice.
Neurological Injury
Neurologically injured adults require frequent brain function assessments. Agents with
a quick offset and onset such as dexmedetomidine or propofol are considered optimal.
In cases of refractory status epilepticus, use of high-dose benzodiazepines may be
needed in patients at risk for propofol-induced infusion syndrome (Table 5).
Nonintubated Patients
Patients without a protected airway who experience serious non-pain-related agitation
are a challenging population to sedate given the respiratory depressant effects of
propofol, benzodiazepines, and opioids. Although single doses of a benzodiazepine or
opioid can sometimes be administered with caution, infusions of these agents should
be avoided. Antipsychotics with sedating properties (eg, haloperidol, quetiapine) may
be a safer alternative to benzodiazepines in some patients. Dexmedetomidine, with its
lack of effect on respiratory drive, may also be beneficial when agitation is persistent.
One RCT compared dexmedetomidine versus placebo in adults with acute respiratory
failure managed with noninvasive ventilation and found that dexmedetomidine was
associated with improved tolerance of noninvasive ventilation, less agitation, and
fewer intubations.101
Sedative Reduction Strategies

Strategies to appropriately reduce and stop IV sedatives are important to formulate as
patients transition through the ICU. In patients with adequate enteral absorption, home
anxiolytics, opioids, and antipsychotics should be restarted when appropriate. If the
use of propofol or an IV opioid infusion therapy is determined to be causing apnea
during a spontaneous breathing trial, a change to dexmedetomidine should be
considered. Dexmedetomidine should also be considered for the treatment of severe
non-pain-related agitation in patients with delirium when agitation fails to respond to
haloperidol therapy.94 Any use of antipsychotics should be reevaluated daily. Oral
clonidine should be considered when patients are being transitioned off of a
dexmedetomidine infusion administered more than 48 hours; the continued need for
clonidine should be regularly assessed.103
SUMMARY
A number of important considerations exist when analgesics and sedatives are used in
critically ill adults. In general, mechanically ventilated adults should be evaluated
regularly with the RASS or SAS and maintained at a light level of sedation unless deep
sedation is a clinical goal. All medications used for analgesia and sedation should be
carefully reviewed for continued need as patients transition out of the ICU.
KEY POINTS
The choice of analgesic to treat pain in critically ill adults requires careful agent
selection based on known medication properties and patient-specific
characteristics.
Multimodal analgesia with nonopioid analgesics may improve pain control and
reduce opioid exposure, particularly in surgical ICU populations.
Most critically ill adults should be transitioned to a light level of sedation at the
earliest opportune time and may not always require continuous sedation therapy.
Short-acting agents, such as dexmedetomidine or propofol, are generally
preferred over a benzodiazepine therapy for mechanically ventilated adults
requiring continuous sedation.
The continued use of analgesics and sedatives initiated in the ICU should be
carefully evaluated daily and should be reevaluated before ICU discharge.
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Delirium Assessment, Prevention, and Management
Christina J. Hayhurst, MD, and Pratik Pandharipande, MD MSc
Objectives
Discuss diagnosis, assessment, and treatment of delirium.

Understand subtypes of delirium.
Key words: delirium, prevention, treatment
Delirium has long been recognized as a pathological syndrome, but as our

understanding of delirium continues to evolve, so does the way we define it.
Ancient Greek literature describes phrenitis (displaying cognitive and
behavioral disturbances, agitation, and restlessness) and lethargus (memory
impairment, somnolence, and listlessness). The term delirium was first used
by the Roman physician Celsus, who described delusions and perceptual
disturbances in association with fever as delirium (the root word delirare
means “to go out of the furrow”). In the 19th century, a French psychiatrist,
Philippe Chaslin, coined the term confusion mentale primitive to describe
“an acute brain disorder, consecutive to an organic significant disease, with
cognitive impairment associated with delusions, hallucinations,
psychomotor agitation, or reciprocally, with psychomotor retardation and
inertia.”1 The inconstant nature of delirium symptoms and variable clinical
presentations have led to multiple attempts at definitions throughout the
modern era. This has made the syndrome difficult to diagnose, study, and
treat. Even the term delirium represents an overarching concept that was
used to encompass all the terms representing acute generalized brain
dysfunction used prior to the Diagnostic and Statistical Manual of Mental
Disorders, Third Edition.2 These terms included acute confusional state,
encephalopathy, acute brain failure, ICU psychosis and even subacute
befuddlement and referred to delirium resulting from acute illness or
intoxications and occurring in different treatment settings or patient
populations (eg, ICU vs non-ICU). Combining all of these clinical
constructs under the term delirium has resulted in a more coherent approach
to clinical practice and research but leads to further questions about specific
definitions and subtypes commonly encountered in the ICU.
DELIRIUM EPIDEMIOLOGY
Delirium is seen in 20% to 50% of ICU patients and in up to 60% to 80% of
mechanically ventilated patients.3,4 Delirium occurs in all patient
populations and age groups. Until recently, delirium was considered an
inconsequential occurrence in critical illness, but mounting evidence now
shows an association of delirium with duration of mechanical ventilation,
ICU and hospital length of stay, costs, mortality, and long-term cognitive
impairment.5-7 Although the attributable risk of death with delirium (versus
the critical illness elements that accompany delirium) is not known, one
study showed that 2 or more days of delirium may predispose patients to an
increased mortality attributed to delirium.8
DELIRIUM DIAGNOSIS
Delirium is defined in the Diagnostic and Statistical Manual of Mental
Disorders, Fifth Edition, as an acute disturbance of consciousness with
inattention accompanied by a change in cognition or perceptual disturbance
that fluctuates over time.9 Three key points to clarify the syntax
surrounding delirium and coma are as follows: First, coma represents the
clinical state of a patient who is unarousable to voice (whether this is due to
disease or to iatrogenic causes such as deliberate or unintentional overuse of
sedation). Second, hallucinations and delusions are not key components of
the diagnosis of delirium, although each may be present in a subset of
patients with delirium. Third, inattention is the most important diagnostic
criterion for delirium (Figure 1).10
Figure 1. Delineation between delirium and coma, highlighting the cardinal symptoms of delirium
The dashed line indicates optional symptoms of delirium (ie, those sometimes present but not
mandatory for the diagnosis of delirium as defined by the DSM-V).
Reprinted by permission from: Springer Nature, Intensive Care Medicine. Understanding

international differences in terminology for delirium and other types of acute brain dysfunction in
critically ill patients, Morandi A, Pandharipande P, Trabucchi M, et al. Copyright © 2008.
Delirium is prevalent but underrecognized; it is missed 70% of the time if

patients are not monitored with delirium detection instruments.11,12 The
Society of Critical Care Medicine PADIS (Pain, Agitation/Sedation,
Delirium, Immobility, and Sleep Disruption) guidelines13 recommend that
all ICU patients be screened regularly for delirium with either the
Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)3,14
(Figure 2) or the Intensive Care Delirium Screening Checklist (ICDSC)15
(Table 1). The CAM-ICU is a well-validated delirium detection instrument
that can be completed quickly, in less than 1 minute, and can be used in
both verbal and nonverbal patients. The CAM-ICU has objective anchors
for the 4 features of delirium it measures: (1) acute change or fluctuation in
mental status from baseline; (2) inattention (the hallmark feature of
delirium); (3) altered level of consciousness; and (4) disorganized thinking.
Patients screen positive for delirium if features 1 and 2 are present along
with either feature 3 or 4. The ICDSC is an 8-item checklist completed over
an 8- to 24- hour period. One point is given for each checklist item present.
The 8 items are level of altered consciousness, inattention, disorientation,
hallucinations-delusions-psychosis, psychomotor agitation or retardation,
inappropriate speech or mood, sleep-wake cycle disturbances, and symptom
fluctuation. A score of 4 points or more constitutes a positive ICDSC and
indicates the presence of delirium.
Figure 2. Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)
Patients are considered to have delirium if they have a Richmond Agitation-Sedation Scale score of
−3 or higher and are CAM-ICU positive by having features 1 and 2 plus either feature 3 or feature 4.
Copyright © 2002 E. Wesley Ely, MD and Vanderbilt University. All rights reserved.
Table 1. Intensive Care Delirium Screening Checklist
Patient Evaluation
Altered level of Deep sedation/coma over entire shift (SAS = 1, 2; RASS = −4, −5) = not assessable
consciousness
Agitation (SAS = 5, 6, or 7; RASS= 1-4) at any point = 1 point
Normal wakefulness (SAS = 4; RASS = 0) over the entire shift = 0 points
Light sedation (SAS = 3; RASS= −1, −2, −3) = 1 point (if no recent sedatives) or 0
points (if recent sedatives)
Inattention Difficulty in following a conversation or instructions. Easily distracted by external

stimuli. Difficulty in shifting focuses. Any of these scores 1 point.
Disorientation
Any obvious mistake in time, place, or person scores 1 point.
Hallucinations- The unequivocal clinical manifestation of hallucination or of behavior probably due to

delusion- hallucination or delusion. Gross impairment in reality testing. Any of these scores 1
psychosis point.
Psychomotor Hyperactivity requiring the use of additional sedative drugs or restraints to control
agitation or potential danger to oneself or others. Hypoactivity or clinically noticeable
retardation psychomotor slowing. Any of these scores 1 point.
Inappropriate Inappropriate, disorganized, or incoherent speech. Inappropriate display of emotion

speech or related to events or situation. Any of these scores 1 point.
mood
Sleep-wake Sleeping less than 4 hours or waking frequently at night (do not consider wakefulness
cycle initiated by medical staff or loud environment). Sleeping during most of the day. Any
disturbance of these scores 1 point.
Symptom Fluctuation of the manifestation of any item or symptom over 24 hours scores 1 point.
fluctuation
Total score (0-8)
Data taken from Bergeron N, et al. Intensive Care Delirium Screening Checklist: evaluation of a new
screen tool. Intensive Care Med. 2001; 27:859-864.
Severity of Delirium
Severity of delirium in the ICU can be assessed with the ICDSC or the
validated CAM-ICU-7, which is derived from the CAM-ICU. The ICDSC
is scored from 0 to 8, with a score above 4 indicating clinical delirium;
patients who score 1 to 3 are considered to have subsyndromal delirium
(SSD). In one study, ICU mortality rates were 2.4% for those patients with
a score of 0 on the ICDSC, 10.6% for patients with a score of 1 to 3 (SSD),
and 15.9% for those with a score of 4 to 8 (clinical delirium)16; however,
another study demonstrated no differences in outcomes.17 More recently,
the CAM-ICU was adapted to include a numbered scale (0 to 2) for each
delirium feature. This severity scale, the CAM-ICU-7, has subsequently
been validated in critically ill patients, and higher delirium scores have been
found to correlate with an increase in mortality.18
Subtypes of Delirium
Delirium has been subtyped according to motoric manifestations into
hyperactive delirium, or hypoactive delirium. Patients who fluctuate
between periods of hyperactive and hypoactive delirium are said to have
mixed delirium. Hyperactive delirium is often associated with increased
activity levels, increased speed of actions or speech, involuntary
movements, loss of control of activity, restlessness, abnormal content of
verbal output, hyperalertness, irritability, and combativeness.19-22 Because
of their disruptive behavior, patients with hyperactive delirium often receive
the most attention from clinicians in the ICU. These patients often pose a
danger to themselves by pulling at intravenous lines, catheters, and
monitors. Hypoactive delirium, alternatively, includes symptoms such as
reduced activity, apathy, listlessness, decreased amount or speed of speech,
decreased alertness, withdrawal, unawareness, or hypersomnolence.19-22
These patients often do not receive the diagnosis of delirium unless they are
actively screened, as they do not exhibit overtly disruptive behavior. Many
studies have determined hypoactive delirium to be the most common form
of delirium in the ICU and associated with worse outcomes than
hyperactive delirium.19-22
ETIOLOGICAL PHENOTYPES
In addition to being subtyped according to motoric manifestations, delirium
can be separated into etiological phenotypes in an effort to delineate the
underlying cause of delirium to guide therapy and predict outcomes. To
date, these etiological phenotypes have consisted of: metabolic, hypoxic,
septic, sedative-associated, and unclassified phenotypes.23 Despite their
individual classifications, these phenotypes often coexist.23 In a recent
study, etiological phenotypes of delirium such as hypoxic delirium and
sedative delirium were associated with worse cognitive function at 3-month
and 12-month intervals.23 Conversely in a small subset of sedated ICU
patients, sedative-associated delirium rapidly reversed after discontinuation
of sedation, and outcomes in these patients did not significantly differ from
those not having delirium.24 A majority of the patients in this study
continued to have delirium after sedation interruption, which portended
worse outcomes.24
PREVENTION AND TREATMENT OF DELIRIUM
Prevention
Many of the nonpharmacological and pharmacological approaches studied
(Table 2) are a combination of prevention and treatment trials since they
did not necessitate patients have delirium prior to enrollment and receipt of
an intervention. This was based on the premise of a high proportion of
mechanically ventilated patients being at risk for delirium and not wanting
to delay intervention till after delirium was set.
Table 2. Delirium Prevention Strategies
Nonpharmacological Pharmacological
Frequent reorientation Avoid benzodiazepines for sedation
Nonpharmalogical sleep protocols, ear plugs Adequate analgesia based on frequent objective monitoring
at night
Avoid deliriogenic medications such as anticholinergics,
Day/night cycle maintenance antihistamines
Early mobilization
Timely removal of catheters and restraints
Use of own eyeglasses/hearing aids
Minimize extraneous noise
Nonpharmacological means of preventing delirium have been extensively

studied in non-ICU settings,25 and ICU teams have extrapolated this
information to develop programs for critically ill patients. These strategies
focus on minimizing known risk factors for delirium. For example, the
patient may benefit from repeated reorientation, provision of cognitively
stimulating activities multiple times a day, nonpharmacological sleep
protocols, and early mobilization applications. Other strategies include
removing catheters and physical restraints as early as safely possible,
allowing patients to use eyeglasses and magnifying lenses if needed,
providing hearing aids and earwax disimpaction for patients warranting
these, correcting dehydration quickly, using a scheduled pain management
protocol, and minimizing unnecessary deliriogenic medication as well as
noise and stimuli. These strategies warrant further investigation in critically
ill patients when bundled as a comprehensive nonpharmacologic protocol.
The ICU Liberation Bundle, as described in previous chapters, is a
liberation and animation strategy focusing on the components known as the
ABCDEFs (http://www.sccm.org/ICULiberation/ABCDEF-Bundles). A
seventh component, G for “Good Sleep,” will be added at the next iteration
of these broad recommendations aimed at improving ICU outcomes. High
compliance with bundle elements has been shown to be associated with
improved survival, decreased incidence of delirium and coma, and
improvement in other patient outcomes.26,27
Pharmacological therapies have not been shown to help in the prevention of
delirium. Haloperidol is a medication frequently studied in regard to
delirium in the ICU. No systematically conducted studies28,29 have shown a
consistent benefit with the use of haloperidol in the prevention/treatment of
delirium and the recent Prophylactic Haloperidol Use for Delirium in ICU
Patients at High Risk for Delirium (REDUCE) trial,30 designed specifically
to evaluate haloperidol for prevention of delirium in ICU patients also
showed no benefit. Thus the 2018 PADIS13 guidelines do not recommend
the routine use of antipsychotic medications to reduce the incidence of
delirium in ICU patients. Therefore, haloperidol should not be used as a
preventative measure for delirium.
Given the association between benzodiazepine medications and the
predisposition to delirium, studies31,32 have shown that patients who are
sedated in the ICU with dexmedetomidine versus a benzodiazepine are less
likely to remain delirious with such an approach. The Maximizing Efficacy
of Targeted Sedation and Reducing Neurological Dysfunction (MENDS)
study found median days alive without delirium or coma to be 7 in the
dexmedetomidine group compared with 3 in the lorazepam group (P =
0.01). Additionally, after the day of randomization, daily prevalence of
delirium was lower in the dexmedetomidine versus lorazepam group (P =
0.004).31 At baseline in the Safety and Efficacy of Dexmedetomidine
Compared With Midazolam (SEDCOM) study, 60.3% of dexmedetomidine
patients and 59.3% of midazolam patients were CAM-ICU positive.
Prevalence of delirium during the study period was 54% in the
dexmedetomidine group compared with 76.6% in the midazolam group (P
< 0.001).32 Although outcomes in these studies favored dexmedetomidine
compared with benzodiazepines, both studies were prevention and
treatment trials and did not specifically target delirium prevention only. In a
study of 700 patients undergoing noncardiac surgery, prophylactic
dexmedetomidine showed reduced postoperative delirium.33 Notably, this
cohort had low acuity of illness scores, so the PADIS committee did not
change its recommendations despite these findings. At this time, the PADIS
guidelines13 do not recommend dexmedetomidine for routine prevention of
delirium in critically ill patients.
Treatment
Regardless of what approach is taken, it can be very advantageous for the
team to have a standardized, agreed-upon method of considering the
differential diagnostic causes of a patient’s delirium. For example, if
delirium is present, the clinical team can briefly consider the most common
risk factors using a simple mnemonic called Dr. DRE (Figure 3).
Figure 3. Dr. DRE causes of delirium
After reversible causes and modifiable risk factors have been addressed and
nonpharmacological strategies have been implemented, pharmacological
interventions should be considered. No published data are available
showing a positive effect of haloperidol or atypical antipsychotics on
decreasing the duration of delirium in adult ICU patients.29,34,35 The
recently published Modifying the Impact of ICU-Associated Neurological
Dysfunction−USA (MIND-USA) study,28 a multicenter, randomized,
placebo-controlled investigation of delirious patients in medical and
surgical ICUs with respiratory failure or shock, concluded that neither
typical nor atypical antipsychotic medications had any statistically
significant benefit in reducing the duration of delirium or affecting any of
the measured patient-centered outcomes. Although no reduction was seen in
the duration of hyperactive delirium in the study, symptomatic control of
agitation may be the only indication for use of antipsychotic medication.
The recommendation is that medication be used for the shortest possible
time and discontinued once agitation resolves. This is in contrast with
recent data showing that up to 50% of ICU patients started on an
antipsychotic medication in the ICU were discharged from the hospital on
the same medication.36 In view of these findings, the 2018 PADIS
guidelines13 do not recommend the routine use of antipsychotic medications
to treat delirium in ICU patients.
Perhaps the most important element of delirium management in the ICU
setting involves communication among the team so that delirium is
assessed, recognized, and potentially managed. To that end, many ICU
teams now present on rounds using the “brain road map,” which is a set of
data containing 3 elements (Figure 4). At each bedside, the nurse (or
another team member such as an intern or a pharmacist) will present the
patient’s (1) target Richmond Agitation-Sedation Scale (RASS) or
Sedation-Agitation Scale (SAS) score; (2) actual RASS or SAS, CAM-ICU,
or ICDSC result; and (3) sedatives and narcotics received. This helps the
team discuss the patient’s cognitive status, compare this with the patient’s
desired cognitive status for that day, determine adjustments needed, and
then explore the causes of delirium if the patient is CAM-ICU or ICDSC
positive that day (eg, using the Dr. DRE tool shown in Figure 3).
Figure 4. Brain road map: a framework for bedside rounds
Abbreviations: CAM-ICU, Confusion Assessment Method in the ICU; ICDSC, Intensive Care
Delirium Screening Checklist; RASS, Richmond Agitation-Sedation Scale; SAS, Sedation Agitation
Scale.
SUMMARY
Delirium is a manifestation of brain organ dysfunction that is highly
prevalent; it is associated with long-term morbidity and prevents patients
from returning to their desired quality of life. Currently, evidence to support
pharmacological approaches to prevent and treat delirium is lacking.
However, evidence is accumulating that meticulous attention in daily
application of the ICU Liberation bundle may reduce the occurrence of
delirium and its associated consequences, with the goal of improved short-
and long-term ICU outcomes.
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16. Ouimet S, Riker R, Bergeron N, et al. Subsyndromal delirium in the
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17. Breu A, Stransky M, Metterlein T, et al. Subsyndromal delirium after
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18. Khan BA, Perkins AJ, Gao S, et al. The Confusion Assessment
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19. Lipowski ZJ. Delirium in the elderly patient. N Engl J Med.
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Early Mobility
Chris Winkelman, PhD, ACNP, CCRN, CNE, FCCM, FAANP,
Kathleen Vollman, MSN, RN, CCNS, FCNS, FCCM, FAAN,
and Heidi Engel, PT, DPT
Objectives
Motivate the reader to adopt an early and inclusive program of

mobility by providing essential resources and detailing
implementation elements.
Describe methods to facilitate the interventions for early
mobility in the ICU.
Identify clinically useful tools for mobility programs in the
ICU, including tools that promote safe patient handling.
Key words: ICU, mobilization, early mobility, rehabilitation,

bundles of care, guidelines, immobility, outcome
The trauma of bedrest takes only a few days to occur, particularly during
critical illness.1,2 The transition from function to horizontal helplessness is
all too common among patients in the ICU when we undermobilize those in
our care. In this chapter, we want to light a fire under reluctant teams so
they mobilize ICU adults. Clinical inertia3 leading to patient immobility is
insidious and unforgiving. The importance and positive outcomes of early
and progressive mobility interventions in the ICU are supported in clinical
practice guidelines.4,5 In the PADIS Guidelines developed by the Society of
Critical Care Medicine, the “I” in PADIS indicates avoid immobility.5
Certainly, there are barriers to early mobility and walking adults in the ICU
and these barriers can lead to clinical inertia. We recognize that team-based
strategies result in optimal care. Many ICU teams integrate mobility into
common practice.6-8 This chapter focuses on established facilitators for
early mobility programs. We urge clinicians to work together to provide this
human-centered intervention to every patient, every day.
SET THE STAGE FOR SUCCESS

“It may seem a strange principal to enunciate as the very first
requirement in a Hospital that it should do the sick no harm.”9
What are the key ingredients for hardwiring the practice of early mobility in
your ICU? To implement mobility interventions, we must change the
culture and the daily practice of the frontline caregiver, the bedside
nurse,10,11 and the interprofessional team.12 In our current work cultures,
too many clinicians see ICU mobility as another task added to a checklist or
shift work. How do we refocus the value of mobility interventions not as
“add-ons” but as practices that are necessary for optimal patient care? We
suggest linking mobility to the nurse’s patient advocacy role of “do no
harm.” By linking mobility to avoidance of harm, a basic value in
healthcare, we recognize and raise the importance of this and other
“routine” interventions.13 Once value is established, the team determines
the steps for implementing regular mobility practice for every patient, every
day.14,15 Context matters! If mobility interventions are not viewed as
essential to preventing patient harm, then routine adoption is unlikely to
occur.16,17
Set the stage for success within your unit’s culture. Identify the individual
who will serve as lead to bring the necessary people together to start the
journey. The composition of the multidisciplinary group at a minimum
includes nurse leadership, frontline nursing staff (influencers), and physical
therapists.12,18 A physician champion will contribute expert knowledge,
remove any physician barriers, and assist in protocol development.19 We
advise forming an inclusive, interprofessional team.7,20
Next, choose a knowledge or translational framework such as Translating
Research Into Practice (TRIP),21 Plan Do Study ACT (PDSA),22 or the
Systems Engineering Initiative for Patient Safety (SEIPS) model.23 A
translational framework provides directional steps to help the team achieve
the practice change. Regardless of the model used, ICU work systems entail
essential components that include people, tasks, tools and technology,
organization and environmental factors, the process of the care, and the
outcomes to measure. A systematic review of mobility research using the
SEIPS model lays out the components to be addressed in each of these areas
to achieve success.24 Table 1 details these essential components based on
the models and reports in the literature.11,25,26
Table 1. Factors for Mobility Success
ICU Work System Process Outcome

People: registered nurse, Every patient is Audit monthly initially, then quarterly:
respiratory therapist, PT, assessed every
OT, interdisciplinary team, day for safety, level Were only patients with exclusionary criteria for
and patient of mobility, and out-of-bed activity not mobilized today?
ability to advance Were safe patient handling devices used?
mobility.
Did a staff member report injury related to mobility
A pre-ICU (staff injury or patient injury)?
functional
assessment is Were tools or screens used to prompt use of
obtained. devices?
A baseline ICU What is the percentage of patients with a
functional status documented admission or prehospital functional
assessment or status score?
score is obtained.
Tasks: The mobility Audit during interdisciplinary rounds or shift change:

protocol is
A protocol is identified or coordinated with Was every patient considered for mobility every
developed. sedation day?
Staff are prepared to interruption and/or How many patients have a targeted sedation goal?
implement the protocol. spontaneous How many patients are at goal?
breathing trial.
The patient is prepared for What is the number of patients who have had
the protocol. Staff consider sedation interruptions or spontaneous breathing
increasing Fio2 trials and active mobility (desired or actual) during
10% during activity. sedation or breathing trial interventions?
Lines and tubes What are family members’ perceptions regarding
are stabilized. mobility-related care?
Family members Were there any mobility-related adverse incidents,
are engaged to such as episodes of hypoxia, line or tube
assist with hygiene, dislodgement, patient reports of discomfort, safety
conversation, and issues (near fall), or equipment malfunction?
encouragement
while patient is out
of bed.
Interdisciplinary activities: An ICU mobility Audit semiannually and annually:

scale or level is
Mobility goals are used to set goals Are goals related to hospital functional status
established on rounds. and record mobility detailed or driving clinical decisions?
The need for PT, OT, and activity completion. What is the time to first activity following ICU
ST is evaluated. Continuous admission?
The need for respiratory physiological What is the trend or number of therapy
therapy is determined. monitoring is consultations?
conducted.
Mobility activity is initiated. What are the associations between ICU or hospital
length of stay and/or days of mechanical
ventilation and dose of mobility?
What is the dose of mobility for patients (ie,
frequency, duration, and distance)?
What are the associations of mobility dose with
patient ICU day, condition, or prehospital
functional status?
What is the association of goals or actual mobility
with patient or family satisfaction?
What is the percentage of patients who walked?
Is the highest level mobility score documented
daily or with each episode of mobility or activity?
Tools and technology: The team and the Audit, implement, or revise annually:
next shift are
The mobility protocol is informed of mobility What stories can be told and re-told to support the
embedded into the EMR. goals. value of early mobility?
Automatic PT consultation The team is What is the percentage of staff who completed the
occurs. educated regarding mobility education module?
Specialty and safe handling the mobility
protocol. Does the percentage of “appropriate” PT or OT
and mobility equipment is
consultations change over time?
readily available. Staff determine
whether a patient What is the number of slings used (assuming
Staff receive training and
needs a PT or OT inventory supports equipment use)?
refreshment related to
mobility safety devices. consultation—
Is there regular documentation of safe handling
mobility care is
equipment used?
Assessments and activities protocolized.
related to mobility are Does annual competency assessment include a
documented during rounds, Staff receive
mobility intervention component?
on whiteboards (or change- education and
of-shift communication), training with safe What is the effectiveness of an automatic PT
and on accessible handling consultation (if this is part of the mobility
flowsheets. equipment. program)? Examples: all patients with >48 hours
of mechanical ventilation; any patients who require
Content is added to ≥2 staff members for assistance to sit at the edge
the EMR to ease of the bed; any patient with an initial ICU functional
the burden of score below some value.
documentation.
Organization and Postprocess Discuss, implement, and evaluate periodically or annually:

environment: measures.
Is an interdisciplinary team leading the change or
Human resources are The medical record
sustaining the mobility program?
available. documents mobility
and use of safe What is the number of champions engaged, and
An interdisciplinary team is handling do champions represent all disciplines?
available to lead change. equipment.
What is the number of rewards and incentives
Communication structures Interdisciplinary provided?
are present through bedside rounds include
handoff, medical records, discussion of Do hand-off reports include content regarding safe
and multidisciplinary mobility strategies and early mobility?
rounds. and level achieved.
Are data or trends from audits communicated
Strategies of engaging Positive regularly?
frontline staff are used, reinforcement (eg,
such as shared Is there a dedicated PT or OT for the unit, and how
audit reports) and
governance, rewards, does that affect mobility practice?
coaching occur
recognition, and regularly.
involvement at every level.
Space is conducive to
engaging in mobility
activities.
Abbreviations: EMR, electronic medical record; OT, occupational therapist; PT, physical therapist;
ST, speech therapist.
Coach and provide positive reinforcement regularly. When we understand

current work systems, we are empowered to overcome barriers within the
environment, engage clinicians, and make it possible for everyone to do the
right thing easily. The process components in the middle column of Table 1
serve as a road map. The outcome components in the third column detail
measures for the team to determine the impact of the intervention at patient,
unit, and organization level.24,27 We must move from a culture of “We just
didn’t think to do it” to one that considers bedrest and missed mobility as
adverse events that are as important as a healthcare-acquired infection.
Do not wait. Mobility investigations have been conducted in heterogeneous
patient populations and settings. Trials that initiated early rehabilitation at a
median of 7 to 8 days into prolonged mechanical ventilation demonstrated
no differences in outcomes.28,29 The best results occur when the first out-of-
bed activity occurs within 48 hours of ICU admission.30,31 Staff should use
safe patient handling and movement guidelines and devices to develop best
practices32,33 such that walking occurs early in ICU patient care.
“We want her family and friends to be present at the bedside to help
us care for her and to keep her oriented and urge her to work with
our team to get out of the bed and begin walking as soon as
possible.”34
DO NO HARM: FIVE ADVANTAGES OF EARLY

MOBILIZATION
Avoids Maladaptation of Antigravity Horizontal State and Preserves

Physiological Efficiency
Bedrest negatively affects cardiovascular, pulmonary, musculoskeletal, and
immune systems.2,35 The human body depends on gravity for muscle tone,
vascular tone, diaphragmatic breathing, bone integrity, gastrointestinal
motility, endocrine regulation, and mind-body integration.1,35,36 Critical
illness and bedrest both increase skeletal muscle catabolism.37,38 Muscle is
a vital organ system that comprises 40% of body mass and has immune
system enhancement capabilities that are worthy of protection.39-42 Muscle
contraction with active exercise decelerates muscle breakdown, prompting
skeletal muscle to release myokines to balance inflammatory responses and
assist with recovery.2
Provides Pain Relief and Palliation

Immobility creates skin breakdown, joint contractures, and musculoskeletal
and abdominal pain.5 Immobility is associated with delirium onset and
severity, and delirium creates significant distress.43-45 Being out of bed and
interactive provides the patient with beneficial exposure to family members,
normal circadian rhythm, natural light, music, and relief of thirst with easier
swallowing.46,47
Reduces Social Isolation to Preserve Patient Identity and Engages

the Family
During the process of awakening and mobilizing an ICU patient, providers
form a therapeutic alliance with the patient that reduces anxiety and
enhances psychological recovery, ultimately contributing to function.48-50
Bedside clinicians can use education and motivational talk to encourage
patients to move and work toward resumption of life after ICU. Family
anxiety can be reduced when family members participate in patient care
activities such as combing hair, filing fingernails, brushing teeth, or sorting
cards and photos; orient the upright patient with conversation of familiar
and important memories; and record the timeline and patient experiences in
a daily diary.51-54 Families want to engage with ICU care, and adding
family care to mobility interventions provides meaningful engagement with
positive outcomes for everyone.
Adds Prognostic Information When a Patient Is Chronically Critically

Ill
Movement for patients carried out to their fullest potential provides an
assessment of patient resilience for treatment or readiness for the removal
of life-supporting medicines and equipment when the patient is medically
stabilizing.55-57 For patients requiring prolonged ICU stays of more than 10
days, ability to participate in functional mobility and strengthening reveals
potential for resilience to new infections and ability to leave the hospital for
home.58
Reduces Financial Burden

The addition of full-time rehabilitation staff in the ICU is cost-effective.
Physical and occupational therapists create financial savings for the
providing institution due to decreased ICU length of stay, reduction of
delirium, and reduction of medical complications, resulting in more
efficient and effective care for the patient.59,60
ASSESS THE PATIENT AND PLAN FOR SAFETY

Mobility interventions are most successful when they occur as a component
of the ICU Liberation Bundle, formerly the ABCDEF bundle.61 In the
bundle, “E” is “early mobility”, emphasizing that it is early mobility that is
the therapeutic target. Early and progressive mobility involves actions that
result in walking the patient. Repositioning an individual in bed is not a
component of active mobility. Prepare yourself, your team, your patient, the
equipment, and the environment for safe, effective out-of-bed mobility.62
Mobility interventions require preparation, clinical judgment, and follow
through. Assess patient readiness and select the mobility activity based on
the results of that assessment. Coordinate care and define goals of
mobilization for that day. For example, the targets of mobility activity could
reflect maintaining or improving strength, endurance, or aerobic capacity or
focus on achievement of activities to resume daily life following
discharge.63
Start with patient assessment. Determine, if possible, the patient’s function
prior to ICU admission. However, determining pre-admission function,
strength, or abilities should not create a delay in starting an ICU mobility
plan of care for the individual. Ideally, a pre-admission functional
assessment reflects direct knowledge of patient activities in his or her
residence. Sometimes, this assessment is a frailty assessment.64 This
baseline assessment helps determine individual dose, intensity, and
frequency of mobility interventions.65,66 Data suggest that proxy reports are
helpful but may differently capture patient abilities compared with self-
report or clinician in-home or residential observation.67 No common
approach has been established to measure pre-ICU or even prehospital
function. However, consider using one of the functional assessments that
examine ICU outcomes to establish baseline functional assessment.68 The
Outcomes After Critical Illness and Surgery group at Johns Hopkins has
created toolkits for clinicians, and these toolkits include measures of
function.69
Next, assess the patient’s status. This effort includes several concurrent
judgments about the patient: determination of physiological stability and
reserve; ability to follow directions; and strength in performing functional
tasks. One source of determining physiological stability and reserve to
guide early mobility decisions for ICU adults is the Society of Critical Care
Medicine’s ICU Liberation Bundle.70 The exclusion criteria in that bundle
are not absolutes. Instead, the criteria are guidelines and do not rule out
early or progressive mobility. Safety concerns are prompts for team
members to determine whether participation in the mobility portion of the
ICU Liberation Bundle needs modification rather than automatic
exemption. Less than 0.1% of mobilization activities result in a change in
physiological status or injury that require an intervention during
mobilization of ICU adults.5 The most common adverse event during out of
bed activity is a decrease in oxygen saturation requiring an increase in
oxygen delivery. An increase in oxygen delivery can be prescribed in
advance of the mobility activity as needed. After determining safe
physiological parameters, consider the patient’s current cognitive status and
physical strength related to function.
After determining if the patient meets safe physiological criteria to
mobilize, assess the patient’s ability to follow directions. Common tools for
this process include the Richmond Agitation-Sedation Scale (RASS) and
the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU).
Generally, a patient’s ability to follow a 2-step command indicates a greater
ability to progress to out-of-bed activity, regardless of the presence of
delirium. Patients who are not responsive due to chemical sedation need
further evaluation. If sedation (eg, a RASS score of –4 or –5) is the
therapeutic goal due to underlying conditions, then the patient may not be
an appropriate candidate to mobilize. If the sedation goal is RASS –2 and
the patient is more sedated than that level, then a conversation about
reducing the sedative dose should be the next step. Mobilization is
associated with postponing the onset and severity of delirium. Do not let
reduced cognition stop mobility interventions. Instead, consider using
devices for safe patient handling (eg, slings, sit-to-stand devices, or walkers
with support). Devices can ensure that the cognitively impaired patient is
surrounded by ergonomic or mechanical support.33
Concurrent with examining the patient’s ability to follow directions, assess
the patient’s strength. Weakness is not a trigger to delay or stop mobility;
rather, it is a trigger to consider devices to provide safety to both the patient
and staff.71,72 Tools to assess patient readiness for a mobility intervention
(ie, an out-of-bed intervention) are described in Table 2.26,57,73-88 In
addition, the table lists several tools to help determine the need for assistive,
safe patient handling devices (ie, the Banner Mobility Assessment Tool and
the Agency for Healthcare Research and Quality nurse-driven mobility
protocol for ventilated patients). Table 2 also lists several tools that
combine assessment with a suggested level of activity, although these tools
have not undergone psychometric evaluation.
Table 2. Tools to Assess Patient Readiness for Mobility and Document Mobility Milestones
Tool Name Source Benefits Drawbacks Comments

Assessment of Patient Readiness Tools
Richmond Agitation- SCCM ICU Liberation
Agitation and Absolute Examines
Sedation Scale (RASS) website: https://
sedation can values for not alertness.
www.sccm.org/ influence the level mobilizing will
getattachment/
of mobility vary with the
41451def-b9f8-404a-
attained. expertise of
8a55-a9aea19c1911/
staff and use
Richmond-Agitation-
of devices to
Sedation-Scale-(RASS) provide
patient safety;
these subtle
judgments are
difficult to
protocolize.
Confusion Assessment Training module at the Robust reliability Both Examines

Method for the Intensive SCCM ICU Liberation
with training; hypoactive attention.
Care Unit (CAM-ICU) website: https://www.
validity and
sccm.org/ICULiberation/
established. hyperactive
Resources/CAM-ICU-
Delirium can delirium can
Training-Manual influence the require
attainment of a adjustments to
high level of mobility
mobility; positive activity, but no
delirium may alert data to
the staff to use protocolize
safety devices or these
additional staff or adjustments
experts during are available
mobility activities. to date.
Hodgson’s Traffic Light Hodgson et al26 Expert consensus. Level of detail An expert,
System for Safety Details issues in makes it interdisciplinary
pulmonary, difficult to consensus panel
cardiovascular, incorporate developed this
and neurological into rounds or tool. It has been
conditions that do EMR. May be evaluated in the
or do not raise more useful cardiothoracic
concerns about as training or ICU
mobility. Visual discussion environment.57
cues (green, prior to
yellow, and red establishing a
“lights”) are helpful unit-specific
clinically. protocol.
SCCM safety criteria for SCCM ICU Liberation

Succinct: 9 Generic: no Exclusion criteria
start/stop website: https://www.
bulleted guidance for for mobility are
rehabilitation/mobilization sccm.org/ICULiberation/
physiological specialty units not absolutes but
(in bed or out of bed) ABCDEF-Bundles/
conditions that in terms of present
Early-Mobility suggest patient devices or opportunities to
should be multiple initiate
excluded from comorbidities. conversation with
mobility today. the
interdisciplinary
team about how
to address safety
concerns.
Recommended Tools for Patient Function While in ICU1,73

ICU mobility scale Tipping et al,74,75 Records the ICU Does not An
Hodgson et al76 adult’s highest specifically interdisciplinary
level of address team in Australia
mobilization. muscle developed this
Excellent interrater strength. measure.
reliability and Places a large
established emphasis on
validity. The mean walking
difference of 0.89- (points 7-10).
1.40 on this 11-
point scale is a
clinically
significant change
in mobilization.
Appears to be
readily adapted to
the EMR
environment.
Functional Status Score Directions and training

Robust validity Cannot Includes 5 ICU-
for the Intensive Care video: https://www.
and established calculate a specific functional
Unit (FSS-ICU) hopkinsmedicine.org/
reliability.77 A score when tasks (rolling,
pulmonary/research/
change of 2-5 more than 2 of transfer from
outcomes_after_critical_
points is 5 functional spine to sit, sitting
illness_surgery/oacis
supported by data tasks cannot at the edge of
_instruments.html as clinically be assessed. bed, transfer from
important.78 Agitated, sit to stand, and
comatose, walking). Each
and confused task is evaluated
patients may using an 8-point
not be able to ordinal scale
follow ranging from 0
directions for (not able to
all 5 tasks, perform) to 7
contributing to (complete
no score. independence).
Physical Function ICU Denehy et al79 Robust reliability, Floor effects This tool was
Test (Scored) (PFIT-s) validity, and occur due to used to guide
responsiveness in the need for decisions about
ICU adults. the patient to level of mobility
follow intervention in
directions one small study.80
(volitional
ability).
Chelsea Critical Care Corner et al81-83 Robust reliability, Small ceiling Has been
Physical Assessment validity, and and floor packaged with an
Tool (CPAx) responsiveness in effects eLearning unit
ICU adults. reported that may be
(20/499). helpful to units
newly starting a
mobility
program.84
Tools for Determining Level or Progression

Banner Mobility Boynton et al85 Validity Focuses on Reports of use in
Assessment Tool (BMAT) established by readiness for the ICU with good
experts. initial walking outcome. Appears
Acceptable session. ICU to be readily
interrater reliability safety integrated with
in acute care considerations EMR.
setting. (such as
integrity of
tubes and
lines) not
addressed.
de Morton Mobility Index de Morton and Lane86 Balance is Developed to Most reports are
(DEMMI) uniquely be specific to from community-
considered. the geriatric dwelling adults.
Minimally population
important change and those with
is 6 points on this chronic
100-point scale.87 conditions.
Agency for Healthcare AHRQ website:

Expert-developed Last updated Includes
Research and Quality https://www.ahrq.gov/
screening, March 2017. PowerPoint slides
(AHRQ) nurse-driven professionals/quality-
algorithm, data No reliability for education.
mobility protocol for patient-safety/hais/tools/
collection tools, or validity
ventilated patients mvp/technical-bundles-
and screening reported.
earlymobility.html tools. Assists in
developing the
structure for an
early mobility
program.
Manual Muscle https://www.jove.com/

Good interrater Patients must This is a standard
Testing/Medical video/2632/manual-
reliability with be able to approach to
Research Council muscle-testing-method-
training. Widely follow a 2-step identify ICU-
(MMT/MRC) sum score measuring-extremity-
accepted as a command. acquired
of 12 muscle groups muscle-strength measure of ICU- Variations in weakness; it
acquired motivation, quantifies
weakness. attention, or strength (0-5
cognitive scale) for 6
function can muscle groups:
affect the shoulder
score. abduction, elbow
Association flexion, wrist
with ability to extension, hip
mobilize is flexion, knee
unclear. extension, and
ankle dorsiflexion.
Each group of
muscles is tested
bilaterally.
Patient-Reported Reid et al88 Established Patients must Uniquely

Functional Scale for the validity and be able to assesses and
Intensive Care Unit reliability. self-report. measures the
patient perception
of function.
Designed to be
administered over
time to capture
changes in
perception.
Tools That Combine Assessment With Selection of Activity Level

Let’s Move It (University AACN website: No reliability or Unclear Safe patient
of North Carolina; https://www.aacn.org/
validity testing whether this handling not
developed at AACN CSI clinical-resources/
reported. Easy to will translate addressed.
Academy) csi-projects/lets-
understand and to other ICUs;
move-it-implementing-
adapt. developed
an-early-mobility-
specifically for
protocol one unit.
Walk This Way (Duke AACN website: No reliability or Unclear Safe patient
Raleigh Hospital; https://www.aacn.org/
validity reported. whether this handling not
developed at AACN CSI clinical-resources/csi-
will translate addressed.
Academy) projects/walk-this-way to other ICUs;
developed
specifically for
one unit.
Abbreviations: AACN, American Association of Critical Care Nurses; CSI, Clinical Scene
Investigator; EMR, electronic medical record or any clinical record; SCCM, Society of Critical Care
Medicine.
Select the mobility activity. While early publications suggested in-bed

movement is a component of mobility activity, the science for mobility
interventions in ICU has evolved to support upright positioning and weight
bearing as the most effective.89,90 Neither weakness nor confusion should
determine ongoing bedrest. Instead, consider how to assist the patient to sit
at the edge of the bed and progress to standing and walking. The use of lift-
and-sling devices illustrated in Figures 1 and 2 provide additional safety to
both patients and staff when a patient cannot complete actions to sit at the
edge of the bed. There are several published protocols that suggest an
activity, based on the assessment of stability, cognition, and strength.91-93
Characteristics of some published protocols are described in Table 2.
Figure 1. Using a sit-to-stand device for a weak patient
Courtesy of Heidi Engel, PT, DPT.
Figure 2. Using a walker to support patient effort and equipment

Courtesy of Heidi Engel, PT, DPT.
Incorporate safe patient handling and mobility devices and practices into all
activities and any protocols.33,72 Hold staff accountable for the regular use
of mobility devices that provide safety for staff and patients. Some evidence
indicates that accessibility of devices, training, and practice result in more
regular use of devices in the ICU.32 Financial modeling indicates that
devices are less expensive than staff injury caused during manual patient
handling.33
Now, implement mobility consistently in the ICU. Teamwork,
communication, and collaboration ensure that mobility is included in a daily
plan of care for every patient, every day.11,12 Overcautious exclusion
criteria will result in delayed or absent mobility interventions. Bedrest
harms our ICU patients, and that harm persists long after discharge from the
ICU. Guidelines regarding the training and knowledge for competent
physical therapist clinical reasoning in the ICU have been published after an
expert consensus process,94,95 and these guidelines can guide decisions
about the roles of the interprofessional team implementing a mobility
program.
EXAMPLES OF APPLYING ICU EARLY MOBILITY IN

PATIENT SCENARIOS
Consider these 4 ventilated patients in a medical ICU:
1. A 47-year-old man with new-onset bulbar weakness resulting in

weakened respiratory and swallowing muscles is intubated, primarily
for airway protection, at a pressure support ventilation of 8/5 and Fio2
of 40%. He is confused and intermittently agitated. The team is
considering extubating him later today and thinks that out-of-bed
mobility should wait until after extubation.
2. A 47-year-old man with advanced terminal lung cancer and a collapsed
fluid-filled lung is intubated for hypoxemic respiratory failure. He
initially required assist control ventilation, but on the same day the
patient was intubated, a chest tube was inserted and placed on
continuous suction. The patient tolerated pressure support ventilation
of 10/8 and Fio2 of 40%. He is alert and calm and is writing notes to
his children on a whiteboard in bed.
3. A 47-year-old man with end-stage liver and kidney disease is listed for
and awaiting a simultaneous liver and kidney transplant. He is now in
the ICU requiring continuous renal replacement therapy and receiving
mechanical ventilation for aspiration pneumonia with settings that
include pressure support 12, positive end-expiratory pressure 7 cm
H2O, and Fio2 40%. He is encephalopathic with a RASS score of –2;
he is receiving a continuous infusion of low-dose vasoactive
medication.
4. A 47-year-old man developed severe acute respiratory distress
syndrome that required paralytic medications during his first 5 days in
the ICU. Today, 7 days after his ICU admission, he requires an Fio2 of
75% at rest. He becomes tachypneic and tachycardic when his
ventilator settings are changed from assist control to pressure support.
He becomes agitated with an asynchronous, distressed breathing
pattern when sedation is lightened to RASS –1.
Each patient has great potential to experience harm when clinicians delay
mobility. Probable harms include delirium onset, increased delirium
severity, prolonged ventilator support with subsequent diaphragmatic
weakness, reduced muscle strength, and decreased function with risk for
discharge to some place that is not home. The first 3 patients can (and
should) be mobilized to an out-of-bed activity, according to the consensus
guidelines. Extubation plans or recent procedures are not compelling
reasons to avoid upright positioning at the side of the bed or standing. Each
of the first 3 patients can (and should) march in place at the bedside or
walk. The fourth patient, diagnosed with acute respiratory distress
syndrome, does not meet criteria for beginning active mobilization and will
stay in bed receiving passive range of motion (to sustain joint but not
muscle integrity) and repositioning (to provide comfort and prevent
pressure ulcer formation) from nurses.
SUMMARY
Early mobilization and walking of critically ill adults are associated with
reduced adverse effects of an ICU stay, especially when that stay is
prolonged. A robust program of early mobility provides favorable
institutional, clinician, and patient outcomes. Early, progressive
mobilization is widely recognized in the literature as both safe and
effective.5 The challenge in implementing early mobility involves moving it
from an individual clinician’s task to a culture of care where
implementation of mobility occurs daily. Neither patients nor clinicians
should be immobilized or inert. Move, walk, implement.
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71. Totzkay DL. Multifactorial strategies for sustaining safe patient
handling and mobility. Crit Care Nurs Q. 2018;41:340-344.
72. Schoenfisch AL, Kucera KL, Lipscomb HJ, et al. Use of assistive
devices to lift, transfer, and reposition hospital patients. Nurs Res.
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73. Parry SM, Granger CL, Berney S, et al. Assessment of impairment and
activity limitations in the critically ill: a systematic review of
measurement instruments and their clinimetric properties. Intensive
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74. Tipping CJ, Bailey MJ, Bellomo R, et al. The ICU mobility scale has
construct and predictive validity and is responsive. a multicenter
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75. Tipping CJ, Holland AE, Harrold M, et al. The minimal important
difference of the ICU mobility scale. Heart Lung. 2018;47:497-501.
76. Hodgson C, Needham D, Haines K, et al. Feasibility and inter-rater
reliability of the ICU mobility scale. Heart Lung. 2014;43:19-24.
77. Hiser S, Toonstra A, Friedman LA, et al. Interrater reliability of the
functional status score for the intensive care unit. J Acute Care Phys
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78. Huang M, Chan KS, Zanni JM, et al. Functional status score for the
ICU: an international clinimetric analysis of validity, responsiveness,
and minimal important difference. Crit Care Med. 2016;44:e1155-
e1164.
79. Denehy L, de Morton NA, Skinner EH, et al. A physical function test
for use in the intensive care unit: validity, responsiveness, and
predictive utility of the physical function ICU test (scored). Phys Ther.
2013;93:1636-1645.
80. Tadyanemhandu C, Manie S. Implementation of the physical function
ICU test tool in a resource constrained intensive care unit to promote
early mobilisation of critically ill patients—a feasibility study. Arch
Physiother. 2016;6:12.
81. Corner EJ, Hichens LV, Attrill KM, et al. The responsiveness of the
Chelsea critical care physical assessment tool in measuring functional
recovery in the burns critical care population: an observational study.
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82. Corner EJ, Soni N, Handy JM, et al. Construct validity of the Chelsea
critical care physical assessment tool: an observational study of
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and implementation of the Chelsea critical care physical assessment: a
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85. Boynton T, Kelly L, Perez A, et al. Banner mobility assessment tool
for nurses: instrument validation. Am J SPHM. 2014;4:86-92.
86. de Morton NA, Lane K. Validity and reliability of the de Morton
mobility index in the subacute hospital setting in a geriatric evaluation
and management population. J Rehabil Med. 2010;42:956-961.
87. Braun T, Gruneberg C, Coppers A, et al. Comparison of the de Morton
mobility index and hierarchical assessment of balance and mobility in
older acute medical patients. J Rehabil Med. 2018;50:292-301.
88. Reid JC, Clarke F, Cook DJ, et al. Feasibility, reliability,
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the intensive care unit: a pilot study [published online January 22,
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89. Schujmann DS, Lunardi AC, Fu C. Progressive mobility program and
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respiratory, muscular system, and functionality of ICU patients: study
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91. Nydahl P, Gunther U, Diers A, et al. PROtocol-based MObilizaTION
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92. Morris PE, Griffin L, Berry M, et al. Receiving early mobility during
an intensive care unit admission is a predictor of improved outcomes
in acute respiratory failure. Am J Med Sci. 2011;341:373-377.
93. Boynton T, Kelly L, Perez A, Miller M, An Y, Trudgen C. Banner
Mobility Assessment Tool for Nurses: Instrument Validation. Am J
SPHM. 2014;4:86-92.
94. van Aswegen H, Patman S, Plani N, et al. Developing minimum
clinical standards for physiotherapy in South African ICUs: a
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95. Skinner EH, Thomas P, Reeve JC, et al. Minimum standards of clinical
practice for physiotherapists working in critical care settings in
Australia and New Zealand: a modified Delphi technique. Physiother
Theory Pract. 2016;32:468-482.
Family Engagement and Empowerment
Giora Netzer, MD, MSCE, and Judy E. Davidson, DNP, RN, MCCM, FCCM
Objectives
Identify strategies to work with families to maximize the

effectiveness of the ICU Liberation Bundle.
Describe how facilitated sensemaking may be used to organize
a model of family-centered care.
Discuss methods by which families may be better supported,
potentially reducing their likelihood of developing the post–
intensive care syndrome–family response (PICS-F).
Key words: family, post–intensive care syndrome, family

engagement, family-centered care, intensive care
Family is the most basic unit of our society and the context for the most
important interpersonal relationships of the vast majority of human beings.
Not unexpectedly, families suffer when a loved one is critically ill. Anxiety,
depression, and stress are common.1 High-intensity emotions can result in
maladaptive coping and impaired problem solving.2 Conceptually, this
constellation of psychological morbidity and cognitive challenges,
combined with the physical hardships encountered, may be considered a
family ICU syndrome.3 After ICU discharge or death of a loved one, these
symptoms persist in a significant proportion of family members for months
or longer,4 termed the “post–intensive care unit syndrome–family response”
(PICS-F).5
As we increasingly recognize the power of families to improve the quality
of care—as well as the moral impetus to support them—the delivery of
family-centered care is now recommended internationally as an essential
element of critical care practice among all disciplines in all age groups.6,7
We further submit that to commit to optimal care for both our families and
our patients is to commit to a paradigm of engagement.8 This approach
empowers families to be active in care, with the goal of improving
outcomes themselves (Figure 1).
Figure 1. A Framework for Family-Centered Care Implementation
THE POWER OF FAMILY AND THE ICU LIBERATION

BUNDLE
The ABCDE bundle was developed as a strategy to optimize ICU care,
decrease patient time on the ventilator, minimize adverse outcomes, and
shorten recovery from critical illness.9 The bundle was endorsed by the
American Association of Critical-Care Nurses in 2011.10 An F was added
to the bundle (ABCDEF) through the Society of Critical Care Medicine
(SCCM) Task Force on Long-term Outcomes From Critical Illness5 to
signify the importance of family inclusion in care and was further promoted
through the SCCM ICU Liberation task force.11 This bundle is now referred
to as the ICU Liberation Bundle. In this chapter, we work backward through
the bundle (FEDCBA) to explore family-centered care in the ICU.
F: FAMILY ENGAGEMENT AND EMPOWERMENT
Facilitated Sensemaking as Conceptual Approach

Facilitated sensemaking is a midrange theory, endorsed by the Society of
Critical Care Medicine, that may be used to organize and execute a model
of family-centered care. The term facilitated sensemaking means to help the
family make sense of what has happened and what their new role is as
caregiver. The facilitated sensemaking model was developed at the same
time as the first family-centered care guidelines using the same evidence
that supported recommendations. Families of critically ill patients navigate
through crisis via a process of adaptation. The adaptation to the situation
can be positive, incomplete, or negative based upon the support received
throughout the crisis. Because clinicians are present at the time of the crisis,
they have the potential to mediate effects of exposure to critical illness
through caring interventions of relationship building, communication,
decision making, and engagement. If a solid relationship is built between
the care providers and the family, time to trust building will decrease,
thereby minimizing anxiety. Relationship building begins with welcoming
family presence and role-modeling caring behaviors at the bedside. It is
proposed in the theory that when people are given sufficient, appropriate,
and timely information, it reduces fear of the unknown. Clinicians decode
the ICU environment for families with repeated and iterative information
assuming that families may have limited retention during crisis.
Each family member will desire a different level of participation in care and
engagement at the bedside. Assess family preferences iteratively over time,
knowing that the longer the length of ICU stay, the more comfortable
families may become with the environment. Preferences may change over
time. Some family members will not want to participate in rounds or care,
and others will need to be involved to maintain a sense of purpose,
belonging, and achievement. Some family members will feel the need to be
present to safeguard the patient until trusting relationships are developed.
Humans often evaluate crises later by reflecting upon what they “did”
during that time. When families are allowed to “do” as much as they prefer,
they will later be able to reflect back and, despite the outcome, find peace in
knowing that they did everything possible to support the patient. When
families are allowed to participate in decision making at the level they
desire, the feeling of inclusion decreases fear while providing purpose.
Because decision making may often overwhelm loved ones, the clinical
team may sometimes need to guide family members into their roles as
surrogate. This includes helping them understand that their decisions reflect
not the family’s desire but rather the patient’s known values. This shifts the
burden of the decision away from the family and instead to the patient.
Family members are to consider the patient’s values and personal beliefs to
guide the collaborative decision-making process.
Further, when provided opportunities for engagement, the family may feel
welcome with a sense of purpose. Teaching family members how to
perform in a caregiver role at the bedside helps with transitions later out of
the ICU as well as in the home during prolonged recoveries (Table 1).
Through a coordinated approach to these caring interventions, families
make sense of what has happened and make sense of their new role as care-
givers through a process of sensemaking facilitated by clinicians. Together
these interventions collectively blunt the limbic system response to stress
and have the potential to prevent or minimize stress disorders, depression,
posttraumatic stress, and, in the case of those patients who die, complicated
grief.12,13 The goal of facilitated sensemaking is to optimize family health,-
protecting both mental health and physiological reserve. We believe
facilitated sensemaking may decrease the family ICU syndrome (FICUS)
and PICS-F.12,14,15 More about facilitated sensemaking may be found at
https://wp.me/Pa13op-JH. It has been found that when families are given
the opportunity to be present and engage in activities, family anxiety
decreases.16-18
Table 1. Some Ways Families Can Participate in Bedside Care
Hand massage
Passive range of motion
Apply lip balm
Mouth care
Watch television with their loved one
Listen to music
Explain day’s events to loved one
Ask team to explain machines in the room
Ask team to explain plan of care, interpret tests
Maintain ICU Diary
Mobility Coach
Report changes in mentation, confusion, pain
Pray
Physical Support of Families

Sleep deprivation is common among families in the ICU, resulting in
significant physical and cognitive effects.19 For this reason, current
guidelines recommend the provision of a lay-flat surface for family sleep.20
The overall wellness of families is crucial, including their needs for
nutrition and respite. For this reason, a family support zone in each room
has long been recommended.21
Navigation Teams
Navigation teams are commonly used in oncology, where care is delivered
by many disciplines and services and care coordination is complex. In
research conducted by patients and families of ICU survivors, a navigator
with exceptional communication skills was strongly recommended to help
families through the critical care experience.22 The concept has been
adapted from oncology for use in critical care with positive outcomes such
as family satisfaction,23 depression, and reduced ICU and hospital length of
stay.24,25 The best approach to implementing navigators has not yet been
identified, and the upfront cost of extra personnel may be prohibitive to
many institutions despite the potential benefits.
Communication Strategies
Communication comes in iterative and often repeated forms from all
members of the team. The first strategy for communication with families is
to decode the environment: explain everything in the room, every sound,
every treatment as it is being delivered, and interpret verbally the patient’s
response to treatment. Do not assume that the family understands any of the
situations that occur throughout the day. At the end of each patient
assessment, the provider has the opportunity to summarize the results of the
assessment in lay terms for family members. Over time they will begin to
read the environment the way that providers do, which will help to decrease
anxiety and fear of the unknown. While administering patient care, the
provider can talk to family members as if teaching a new nurse or resident;
this helps the family to feel welcome, make sense out of the situation, and
know that the provider cares. When the family is given the respect
of open communication, trust will build.

Communication opportunities also exist before, during, and after each set of
rounds. If the family is present prior to rounds, the nurse may prepare them
by asking about any questions they had hoped the physicians would answer.
Those questions that can be handled by the nurse can be taken care of then,
while helping to ensure that the remaining questions are covered during
rounds. The nurse may ask the family what information they had hoped to
share with the physician during rounds. This information can be culled into
a brief report of items that would be pertinent to rounds or handled
separately at another time during the day. Where studied, between 85% and
100% of families preferred the option of being present at rounds. Family
presence at rounds builds trust, improves their perception of the team, and
may even provide useful information on patient history or response to
medications or treatments to further refine the treatment plan.7,16,26
Information also may be summarized and discussed in more detail at
routine family meetings. Prior to a family meeting, the input from
consultants is gathered and collated so that information from various
members of the team does not conflict. A wrap-around approach that
includes both these formal and informal meetings may be the approach of
choice.27 Standardized methods of conducting family meetings may
improve family outcomes such as satisfaction, anxiety, and depression.28
Allowing the family to express their concerns and answering their questions
before presenting treatment options is advocated. The use of a standardized
structure for family meetings, the VALUE mnemonic (Values comments
made by the family, Acknowledges their emotions, emphasizes Listening,
seeks to Understand the patient as a person, and Elicits family questions)
reduces posttraumatic stress disorder, anxiety, and depression among family
members whose loved ones are at the end of life.29
Providing an information brochure may improve family members’
understanding of prognosis and reduce symptoms of posttraumatic stress
disorder,30 and written materials—such as a “toolkit”—may help reduce
anxiety symptoms.17,31 Video-based approaches may improve families’
understanding of therapies.32
E: EARLY MOBILITY AND EXERCISE

Enlisting the family member as mobility coach is a meaningful engagement
strategy.33 Models of rehabilitative care have long viewed families as an
essential part of the recovery process. This approach is part of subacute
rehabilitation model of 24-hours a day rehabilitation. We can use this
philosophy to shift our paradigm in the ICU.34 Enlisting families can
improve both process and clinical outcomes. Inviting families to participate
in early mobilization can improve implementation.33 Formally including
families as essential stakeholders in protocolized early mobilization reduces
both the duration of mechanical ventilation and the ICU length of stay.35
Instruct family members about the mobility protocol and milestones for
achievement. Explain at which level the patient currently performs and
describe realistic expectations for advancement over time. Provide the
family with instructions on how to perform passive range of motion
independently so they can help in between other mobility activities. In-bed
activities such as foot pumps and supine cycle ergometry can also be
designated to family members as coaches to monitor and encourage. Inform
families that mobility is one of the only interventions known to decrease
delirium; efforts at keeping the patient mobile can be brain protective.
Coach families through their role as appropriate to the patient’s condition
and needs so families are not tempted to mobilize patients independently or
beyond the patient’s capabilities.
D: DELIRIUM ASSESSMENT, PREVENTION, AND
MANAGEMENT
As can be expected, family members who witness patient delirium can be
overcome with feelings of helplessness and anxiety.36,37 Family members
need to be forewarned about the possibility of delirium and told that
delirium is an acute, yet reversible condition often stimulated by the
medications administered during critical illness such as vasopressors and
benzodiazepines or physiological triggers such as hypoxemia.
Family presence has been found to decrease delirium in the critically ill.38
A recent, cluster-randomized trial found no change in delirium rates with
increased hours of family presence, further rebutting concerns that families
at bedside could provoke delirium. As well, this trial found benefit among
family members, with reduced anxiety and depression.39 It has been
suggested that family members may help delirious patients by engaging the
patient with cognitive strengthening activities. The family can be
encouraged to discuss current events, read the newspaper, watch preferred
sports or news channels together, and discuss home activities. Diversional
activities such as playing simplified card games or word puzzles may also
keep the patient’s brain engaged.40
Family may help the clinical staff with screening for delirium.41 Indeed, it
is reasonable to conclude that family would notice normal versus abnormal
mentation and cognition before healthcare providers who have not
witnessed the patient’s baseline. Preliminary tests using families to support
delirium screening show promise.42 Encouraging families to report changes
in cognition could result in early discontinuance of offending agents.
Families can serve in the role of cognition coach. Articulating the
importance of this role provides families with concrete and meaningful
purpose while present. Because there is no known cure for delirium, inform
families about the temporary and unpredictable nature of delirium. Explain
to families that after potential triggers for delirium are removed and issues
such as low oxygen levels are treated, the patient may benefit from
cognition support and mobilization, but the delirium might not resolve until
the critical illness has passed. Family education materials may be found at
https://www.icudelirium.org/.
During the time when a patient is not conscious or is delirious, the family
might consider recording events in a family diary. Clinicians may
participate in diary writing by adding messages of hope and caring or
apologies for painful treatments. Clinicians may also proactively describe
events and treatments known to trigger hallucinations in delirious patients,
such as entering a computed tomography scanner, receiving an indwelling
urinary catheter, being restrained, and undergoing endotracheal suctioning.
Occasionally such events have been misinterpreted by the delirious brain as
entering an oven, being raped, being imprisoned, or being tortured.43
Although the data on diaries has had varied levels of effect, there have been
no reports of patient or family harm. Diaries have been shown to decrease
long-term psychological outcomes in both patients and families. The diaries
help family members iteratively process daily events. After delirium
resolves, diaries can be used to help the patient patch together a true
account of the time he or she missed, opening up a dialogue about
nightmares, illusions, or hallucinations that may have occurred during the
delirious state.7,44
Diary entries focus on providing narrative context to a stay that may not be
remembered, daily events, and notes of hope and caring. Diaries do not
contain lab tests and data normally found in the medical record. For this
reason privacy concerns are minimized. Staff do have unfounded fears
regarding privacy concerns. It is known that transparency and caring
decreases likelihood of litigation.45 Since the purpose of diaries is to care
and inform in a caring manners, the net effect is thought to be positive. At
this writing there are no known issues with litigation due to diaries.
Instructions on how to navigate these risk management concerns or obtain
family education materials regarding diaries may be found at
http://www.icu-diary.org/diary/start.html.
C: CHOICE OF ANALGESIA AND SEDATION

Increasing data support an approach of lighter sedation. Vincent46 proposed
the eCASH construct, which stands for early comfort using analgesia,
minimal sedatives, and maximal humane care. Humane care requires
person- and family-centeredness. In eCASH, family presence is encouraged
to augment the comfort of the patient and to help families reorient and
comfort their loved ones. Clinical teams may consider this approach.
A randomized clinical trial of 373 mechanically ventilated patients found
that patient-directed music listening reduced anxiety and also reduced the
total amount of sedation needed.47 Although the intervention in this study
was performed by a music therapist, it can be reasonably extrapolated that
family members can help guide and play music that will benefit the patient.
B: BOTH SPONTANEOUS AWAKENING TRIALS AND

SPONTANEOUS BREATHING TRIALS
Family is an important and underused resource during the spontaneous
breathing trial (SBT). The family can provide benefit by working with
respiratory care, especially during these trials.48 Family members can use
distraction techniques to address patient anxiety during the SBT. In this
setting, music may also be of benefit: One study using music during SBTs
found that it decreased reported anxiety and lowered pulse and respiratory
rate.49
A: ASSESSMENT, PREVENTION, AND MANAGEMENT

OF PAIN
A large, systematic review in the pediatric literature found that procedural
pain can be reduced using distraction, hypnosis, and preparation
techniques.50 Families in both pediatric and adult ICUs can be trained to
provide these tools to their loved ones. The presence of families during
procedures provides comfort and reassurance to patients and may assist
clinicians in the safe completion of bedside procedures. Although data are
sparse, given the lack of compelling argument against this practice, this
approach can be implemented in adult ICUs (as it has been previously in the
pediatric setting).51
FAMILIES AND POST-ICU PATIENT TRAJECTORIES

Families are caregivers for patients both before and after critical illness; and
empowered in this role through the continuum of care.34 Families play a
critical role in determining whether survivors’ functional limitations
become disabilities.52 An example can be found in the stroke literature, in
which stronger family support is associated with increased functional
outcomes.53 Similarly, outside of the ICU, family support is a key risk
factor for preventing long-term institutionalization among those with
dementia.54
A large proportion, perhaps even a majority, of critical illness survivors
require caregiving assistance from family members.55 The crucial role that
families play in long-term outcomes makes it especially important that we
anticipate the challenges they face after ICU discharge. As discussed above,
families suffer a spectrum of psychological morbidities, termed PICS-F.
Families are affected financially by the responsibilities of caregiving for
their surviving loved ones. Family members must frequently leave work,
change their jobs, or reduce work hours in response to these needs.55,56 We
need to anticipate this strain in order to maximize our patients’ trajectories.
SUMMARY
Maximizing the benefit of the ICU Liberation Bundle requires that we
approach family engagement thoughtfully. More than a goal in and of itself,
family engagement has the potential to improve outcomes in each discrete
component of the pathway as well as long-term outcomes.
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2017;98:931-939.
36. Bull MJ. Delirium in older adults attending adult day care and family
caregiver distress. Int J Older People Nurs. 2011;6:85-92.
37. Schmitt EM, Gallagher J, Albuquerque A, et al. Perspectives on the
delirium experience and its burden: common themes among older
patients, their family caregivers, and nurses. Gerontologist.
2019;59:327-337.
38. Rosa RG, Tonietto TF, da Silva DB, et al. Effectiveness and safety of
an extended ICU visitation model for delirium prevention: a before
and after study. Criti Care Med. 2017;45:1660-1667.
39. Rosa RG, Falavigna M, da Silva DB, et al. Effect of flexible family
visitation on delirium among patients
in the intensive care unit: the ICU visits randomized clinical trial.
JAMA. 2019;322:216-228.
40. Pun BT, Balas MC, Davidson J. Implementing the 2013 PAD
guidelines: top ten points to consider. Semin Respir Crit Care Med.
2013;34:223-235.
41. Rosgen B, Krewulak K, Demiantschuk D, et al. Validation of
caregiver‐centered delirium detection tools: a systematic review. J Am
Geriatr Soc. 2018;66:1218-1225.
42. Krewulak KD, Sept BG, Stelfox HT, et al. Feasibility and acceptability
of family administration of delirium detection tools in the intensive
care unit: a patient-oriented pilot study. CMAJ Open. 2019;7:E294-
E299.
43. Black G. Gyroscope: A Survival of Sepsis. Infinity Publishing; 2011.
44. McIlroy PA, King RS, Garrouste-Orgeas M, Tabah A, M. R. The effect
of ICU diaries on psychological outcomes and quality of life of
survivors of critical illness and their relatives: a systematic review and
meta-analysis. Crit Care Med. 2019;47:273-279.
45. Lambert BL, Centomani NM, Smith KM, et al. The “Seven Pillars”
response to patient safety incidents: Effects on medical liability
processes and outcomes. Health Services Research. 2016;51:2491-
2515.
46. Vincent J-L. Optimizing sedation in the ICU: the eCASH concept.
Signa Vitae. 2017;13(suppl 3):10-13.
47. Chlan LL, Weinert CR, Heiderscheit A, et al. Effects of patient-
directed music intervention on anxiety and sedative exposure in
critically ill patients receiving mechanical ventilatory support: a
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the intensive care unit. In: Netzer G, ed. Families in the ICU: A Guide
to Understanding, Engaging, and Supporting at the Bedside. New
York, NY: Springer Press; 2018:315-326.
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treatment in the management of stress for patients being weaned from
mechanical ventilation. J Music Ther. 2010;47:198-219.
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interventions for needle‐related procedural pain and distress in children
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thinking about long-term outcomes after critical illness. Semin Respir
Crit Care Med. 2012;33:327-338.
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M699.
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life after prolonged mechanical ventilation. Crit Care Med.
2004;32:61-69.
The Importance of Good Sleep for Recovery From
Critical Illness
Gerald Weinhouse, MD, and Yoanna Skrobik, MD
Objectives
Describe the importance of good sleep for good recovery from

critical illness.
Review the effects of critical illness and the ICU environment
on the sleep of critically ill patients.
Describe ways to assess and document sleep in the ICU.
Summarize the Pain, Agitation, Delirium, Immobility, and
Sleep (PADIS) guidelines to improve sleep in the ICU.
Key words: Rapid eye movement (REM) sleep, non-rapid eye

movement (NREM) sleep, delirium, circadian rhythm,
inflammation, immunity, delayed sleep phase
Critically ill patients are engaged in a battle to survive. It is intuitive to

believe that optimizing all of their physiological parameters (as we do in
stabilizing blood pressure in shock states) will improve their outcomes.
Sleep is essential to well-being and, indeed, to life itself, yet our
understanding of the role that sleep plays remains limited. Sleep is a
biological function that has been present throughout evolution across all
living species. In addition to being a biological imperative, sleep is an
important determinant of optimal task performance, concentration,
attention, and cognition.
In recent years, we have gained a better understanding of how some
physiological systems depend on sleep and of the short- and long-term
consequences of sleep loss for brain health, psychological well-being, and
the normal function of other organ systems. This chapter aims to summarize
these findings, consider how sleep may be important to our critically ill
patients, and summarize the Society of Critical Care Medicine’s new Pain,
Agitation, Delirium, Immobility, and Sleep (PADIS) guidelines for sleep in
the ICU.
NORMAL SLEEP
Normal sleep is characterized by two very distinct stages: rapid eye
movement (REM) and non–rapid eye movement (NREM). NREM sleep is
further divided into light and deep sleep; their “normal” proportion varies
over an adult’s life, with less deep NREM sleep as we get older. REM sleep,
however, is preserved throughout adulthood and occupies approximately
20% to 25% of the time spent asleep. REM sleep recurs approximately
every 90 minutes and increases in duration over the sleep period.
Our sleep-wake cycles are governed primarily by two physiological
systems.1 The circadian rhythm, our biological clock, is the mechanism by
which we adapt sleep to our external environment and is mostly influenced
by light. This bimodal cycle is responsible for our propensity to be sleepy in
the late afternoon and late at night and most alert in the morning and early
evening. The pineal gland’s melatonin secretion and suppression are
integral to this process. Homeostatic control, which builds increasing
pressure to sleep the longer we are awake, is the other major sleep
determinant. The propensity to sleep after a period of sleep loss can be
overwhelming. Homeostatic control is thought to be due to accumulation of
adenosine.2
Poor sleep in the community is surprisingly common. Insomnia alone
affects 10% to 20% of adults; estimates for insomnia vary widely
depending on its definition.3 The odds of developing obstructive sleep
apnea increase with advancing age, troubling 3% to 7% and 2% to 5% of
adult men and women, respectively.4 Patients with insomnia or other sleep
disorders are less likely to ever sleep normally and are thus at greater risk
for having poor sleep during their critical illness.5,6
SLEEP IN THE ICU

Critically ill patients sleep poorly, and ICU survivors remember their poor
sleep during their critical illness as having adversely affected their ICU
experience.7,8 Some describe it as equally stressful as pain and inability to
communicate.
Sleep fragmentation (disruption) and sleep stage deprivation (REM and
deep NREM) in the ICU are common even if patients sleep as many hours
as they usually do during a 24-hour period.9 The ICU environment,
medications (many of which suppress REM and deep NREM sleep), and
critical illness itself all contribute to this sleep disruption (Table 1).
Furthermore, light exposure and other environmental and care-related
disruptors inherent to the ICU environment play havoc with circadian
rhythms. Events considered as harmless as turning on a light to draw a
blood sample can worsen circadian patterns and sleep quality.10,11
Table 1. Effects Of Commonly Used Medications on Sleep
Medication Effect on REM Effect on NREM Other

class
Antidepressants Decrease Increase N2, variable Trazadone may increase N3
effect on N3
Benzodiazepines Decrease Increase N2
α-agonist Decrease Increase N3 Increase in N3 not demonstrated

in the critically ill
Opioids Decrease Decrease N3
Typical Mild decrease Mild increase

antipsychotic
Atypical Decrease (except Increase N3 (except

antipsychotic olanzepineolanzepine) quetiapine)
Corticosteroids Decrease Decrease N3
β-blocker Decrease
Vasopressors Decrease Decrease
Melatonin No effect No effect on N2 or N3
Effects on sleep architecture determined in healthy volunteers unless otherwise noted. Most
medications have not been studied in the critically ill.
Abbreviations: N2, light sleep; N3, deep sleep, “slow-wave” sleep; NREM, non-rapid eye movement
sleep; REM, rapid eye movement sleep.
Critically ill patients experience the misalignment of the circadian and

homeostatic systems most typically in the form of a phase delay,12 meaning
that sleep onset occurs later than normal and sleep continues until later than
normal. Mistimed sleep with misaligned circadian and homeostatic triggers,
as may occur with shift work, for example, has adverse health effects
including impaired glucose tolerance and insulin resistance.13,14
To complicate matters further, behavioral manifestations of sleep and
wakefulness can be discordant with electrophysiological data in critically ill
patients.15,16 Specific electroencephalographic (EEG) signs are considered
physiological markers for wakefulness and the sleep stages. In the ICU,
however, patients who look awake may fulfill EEG criteria for sleep
(“pathological wakefulness”). Conversely, those who appear asleep may
have EEG manifestations of wakefulness (“atypical sleep”). Some patients
also lack the characteristic EEG signs of stage 2 sleep, specifically sleep
spindles and K complexes. This may be important because sleep spindles
and the normal electrical organization of brain waves are critical
components of information processing.17
The poor sleep experienced in the ICU often persists long after ICU
discharge.18 Survivors of a critical illness may have difficulty sleeping for
at least months if not years beyond their hospitalization, which may affect
their quality of life and, potentially, their recovery. Chronic sleep
deprivation is a stressor that has consequences for mood and cognition as
well as autonomic and metabolic regulation.19
PURPOSE OF SLEEP AND CONSEQUENCES OF
SLEEP LOSS
The discovery of EEG technology in 1924 made it possible to establish a
physiological definition of sleep and the sleep stages. Seven decades of
research have led to a greater understanding of the role of sleep and the
health-related effects of sleep loss.
Sleep, Memory, and Cognition

Sleep has long been known to influence memory. Healthy sleep enables
both selective memory and selective forgetting, which, in combination,
make learning possible.20 NREM sleep is most important to processing
fact-based memory, and REM sleep is integral to the formation of
emotional memory and giving those memories context.21
Since the altered sleep of critically ill patients and ICU delirium share
related manifestations, including altered cognition, memory, and mood, it is
tempting to consider that abnormal sleep may cause delirium. The loss of
deep NREM and REM sleep has been described in studies addressing the
bidirectional relationship between disturbed sleep and abnormalities of
cognitive and mental health.22 This association has led to speculation that
the NREM and REM abnormalities observed in critical illness could render
ICU patients more vulnerable to the clinical manifestations of delirium.
This association remains unproven. Both delirium and sleep are challenging
to capture with precision in the ICU setting.23,24 Although some studies
correlate sleep disruption with delirium in specific populations, other
studies have not shown an association. Before-and-after observational
studies have shown that multidisciplinary bundles containing sleep-
enhancement components appear to be associated with a lower prevalence
of delirium, although sleep efficiency improvement with the intervention
was apparent in only one study.25-27 Moreover, grouping the most
commonly reported sleep disruptors (ie, pain, discomfort, anxiety-fear,
noise, care activities) captures only 33% to 43% of the determinants
reported by ICU patients leading to poor sleep quality. This suggests that
although bundles may help, other factors beyond those amenable to ICU
environment modification may also play a role. Delirium preventive, sleep-
enhancing measures should be individualized based on patient preferences
and home sleep patterns.
Sleep and Brain Health

In mice, clearance of metabolic waste from the central nervous system is
enhanced during sleep.28 A pathway akin to the lymphatic system, the
“glymphatic” system, has been described whereby the glial cells shrink and
the extracellular space expands to facilitate greater waste removal during
sleep than during wakefulness. This system was shown to be important to
clearing potentially toxic buildup of proteins such as amyloid. Whether
these mechanisms exist in humans, and whether any relationship exists
between “waste-clearing” and short-term or long-term cognitive capacity,
are uncertain.
Sleep, Inflammation, and Immunity

Both sleep- and circadian-dependent processes regulate inflammation.29 In
addition, sleep regulates adaptive immunity, which leverages
immunological memory and reacts to microbiological challenges. Sleep
also regulates innate immunity, the response to a microbiological challenge
based on the primitive antigens found on microbes.30 Even a single night or
part of a night of sleep loss or sleep fragmentation heightens the
inflammatory response and diminishes both innate and adaptive immunity
reactivity. Whether the degree of sleep deprivation in ICU patients
correlates with their capacity to survive sepsis or avoid secondary infections
has not been studied.
Conversely, inflammatory mediators affect permeability of the blood-brain
barrier. Whether increased central nervous system exposure to these
inflammatory mediators during a critical illness or from pharmacological
agents alters sleep quality or cognition is currently fueling speculation and
scientific investigation.31
Sleep and Metabolism

During normal sleep, our basal metabolic rate decreases by around 15% to
reach a minimum by morning, and protein synthesis during sleep relative to
wakefulness is enhanced.32,33 This is one of the reasons that sleep is
thought to serve a restorative function.
The responses of metabolism-regulating hormones such as insulin are
blunted after just one night of sleep deprivation.34,35 Whether the sleep loss
experienced by critically ill patients contributes to clinical hyperglycemia, a
predictor of poor outcome,36 is unknown.
HOW CAN SLEEP BE IMPROVED IN THE ICU?

Clinicians must respect the patient’s perceptions and needs for the comfort
of sleep. It is incumbent upon us to minimize iatrogenic sleep disruption to
the extent allowed by our patients’ condition.
Sleep Assessment and Documentation

Helping patients sleep while they are critically ill first entails asking how
they sleep when they are well. We propose assessing patients’ normal sleep
hours, use of sleep aids, and prior diagnoses of sleep disorders (Table 2).
ICU interventions may exacerbate an underlying condition (eg, opioids and
benzodiazepines worsen airway obstruction in untreated obstructive sleep
apnea), which highlights the importance of documenting sleep-related
comorbidities.
Table 2. Suggested Elements of Sleep Assessment
1. Sleep assessment on ICU admission
Normal sleep hours (bedtime/waketime, number of hours, number of awakenings)

Sleep comorbidities, ie, insomnia, sleep apnea, restless legs syndrome, etc.
Use of sleep aids
Nonpharmacologic (music, fan, CPAP, eye mask, white noise, etc.)
Pharmacologic (over-the-counter such as melatonin or prescription)
2. Daily sleep assessment in the ICU

a. 0 2 4 6 8 10
Worst night sleep Best night sleep
What woke you up?

Pain
Anxiety
Noise
Light
Staff
Other
b. Richards-Campbell Sleep Questionnaire
Place an “X” on the answer line for each of these questions. Place your “X” anywhere on the line that you
feel best describes your sleep last night.
1. My sleep last night was:

Deep _________________________________________Light Sleep
2. Last night, the first time I got to sleep, I:
Fell almost immediately______________Just never could fall asleep
3. Last night I was:
Awake very little__________________________Awake all night long
4. Last night, when I woke up or was awakened, I:
Got back to sleep immediately___________Couldn’t get back to sleep
5. I would describe my sleep last night as:
A good night’s sleep_________________________A bad night’s sleep
Daily reassessment is necessary to evaluate the efficacy of the sleep care

plan and determine the need for readjustments (Table 2). Staff should ask
patients about sleep disruptors and determine whether they can be
minimized. Sleep duration and quality can be assessed with tools such as
the Richards Campbell sleep questionnaire. Provider observation of
patients’ sleep-wake time, however, may be imprecise.37,38
Nonpharmacological Interventions
A common feature of stressful situations is that they create a need to
maintain vigilance. Studies addressing how stress-related neurobiological
changes in animals and humans affect, lighten, and fragment sleep support
the principle of identifying reversible stressors and reassuring patients.
Knowing patients’ normal sleep patterns can help individualize care plans
to facilitate sleep. For example, in studies that assessed patient preferences,
some patients were reassured by hearing voices nearby, whereas other
patients preferred silence, highlighting how variable personal preferences
can be. Numerous studies support the benefits of nonpharmacological
interventions in improving sleep in the ICU.24
Providing a safe, comfortable environment for sleep to occur and
minimizing noise, light, and care-related disruptions are now the ICU
standard of care. Noisier or open area environmental disruptions can be
mitigated by offering ear plugs and eye masks. Allowing uninterrupted rest
without diagnostic testing and nursing interventions should be routine, and
exceptions should be made only when required by the patient’s condition.
Pain assessment and effective analgesia must be optimized. Strategies to
promote both physical and mental relaxation should be individualized,
including forearm pressure relaxation techniques delivered by nurses or
family members, massage therapy, guided imagery or virtual reality, a warm
or weighted blanket, music, or white noise.39-43 Since immobility or
restricted movement and worry, anxiety, and fear rank highly among the
sleep disruptors described by ICU patients, addressing these factors may
also benefit sleep.
Pharmacological Interventions
The request for pharmacological interventions to promote sleep is often
initiated by bedside personnel, and sleep-promoting agents may also be
requested by patients and their family members. Pharmacological
interventions to induce or preserve sleep have not been well-studied in this
patient population. ICU patients are among the most medicated hospitalized
patients, and many interventions (eg, inotropes, corticosteroids) interfere
with sleep or circadian rhythms indirectly (Table 1). Adding medication in
this context may have unintended consequences without achieving the
intended goal, as described below.
Three trials evaluated melatonin to improve sleep in the critically ill.44-46
These studies were limited by their small size and sleep assessment
methods, in that none used polysomnography. The benefit was minor in
these potentially biased studies. Although the cost of melatonin is low, its
unregulated production means that its quality control cannot be ascertained.
A recent study suggested that commercial North American products
contained −83% to <+478% of the labelled melatonin content.47 As a result,
the PADIS guidelines group made no recommendation for or against the use
of melatonin. Because its adverse effects are lesser than those described
with other pharmacological sleep aids, however, some practitioners choose
to administer melatonin.
Ramelteon, an FDA-approved melatonin receptor agonist, resembles
melatonin in that few adverse events are reported. Recent studies have
provided conflicting results regarding the efficacy of ramelteon to improve
sleep and reduce delirium.48,49
The belief that sedatives improve sleep contrasts with extensive evidence in
non-ICU and ICU settings showing that all γ-aminobutyric acid (GABA)
agonist category drugs (ie, benzodiazepines, propofol) suppress deep
NREM and REM sleep.50-52 Therefore, no sedative infusion can be
recommended or considered desirable specifically for the purpose of
improving sleep quality in the critically ill.
If nocturnal pharmacological sedation is necessary to control agitation or
anxiety, however, then dexmedetomidine, an α2-agonist, may constitute the
least harmful of sedative choices. In healthy volunteers, dexmedetomidine
may increase “biomimetic” deep NREM sleep, leading to a compensatory
decrease in REM.53,54 In the limited studies in critically ill adults in which
baseline sleep architecture was almost always abnormal, this deep NREM
increase was not observed.55-57 Nocturnal dexmedetomidine infusions
(from 10 pm to 6 am), however, increase stage 2, NREM sleep and may
reduce the incidence of delirium.58 Other sleep aids used by practitioners,
including typical and atypical antipsychotics, antihistamines, and
antidepressants, have not been studied in the critically ill. Their use must be
weighed against their many potential adverse effects.
PADIS GUIDELINES: SLEEP SECTION SUMMARY OF

RECOMMENDATIONS TO FACILITATE SLEEP IN
CRITICALLY ILL ADULTS
The 2018 PADIS guidelines24 are the first to include a section addressing
sleep. A rigorous review of the available literature was conducted to codify
evidence-based recommendations. A summary of the actionable
recommendations includes the following:
1. We suggest using noise and light reduction strategies to improve sleep

in critically ill adults (Conditional recommendation).
2. We suggest using assist-control ventilation at night (vs pressure
support ventilation) for improving sleep in critically ill adults
(Conditional recommendation).
Comment: Although assist control may be a better mode of
ventilation for sleep in several small studies, increasing
sedation to enable assist control ventilation is not
recommended.
3. We make no recommendation regarding the use of melatonin to
improve sleep in critically ill adults (Conditional recommendation).
4. We make no recommendation regarding the use of dexmedetomidine
at night to improve sleep.
Comment: If a sedative infusion is indicated for a
hemodynamically stable critically ill adult overnight,
dexmedetomidine may be a reasonable option because of its
lesser disruption of sleep architecture.
5. We suggest not using propofol to improve sleep in critically ill adults
(Conditional recommendation).
6. We suggest using a sleep-promoting, multicomponent protocol in
critically ill adults (Conditional recommendation).
SUMMARY
Sleep is necessary for the health and optimal function of physiological
systems critical to survival.
Critically ill patients sleep poorly as a result of both their illness and
conditions in the ICU hostile to sleep.
Poor sleep may be a modifiable risk factor for several adverse ICU
outcomes.
To improve patients’ sleep while they are in the ICU, it is necessary to
understand their normal sleep, create an environment conducive to
sleep, allow enough uninterrupted time for sleep, avoid iatrogenic
disruptors (such as certain medications) of sleep to the extent possible,
and assess sleep daily.
We sleep to learn, to remember, to forget, to feel well, to recover, to
heal both physically and psychologically, and to defend ourselves from
large and microscopically small predators. Better sleep may affect the
well-being and survival of our vulnerable critically ill patients and
should, at the very least, be a requisite component of patient-centered,
compassionate care.
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administration of ramelteon, a melatonin receptor agonist, on the
duration of stay in the ICU: a single-center randomized placebo-
controlled trial. Crit Care Med. 2018;46:1099-1105.
49. Jaiswal SJ, Vyas AD, Heisel AJ, et al. Ramelteon for prevention of
postoperative delirium: a randomized controlled trial in patients
undergoing elective pulmonary thromboendarterectomy. Crit Care
Med. 2019;47:1751-1758.
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sleep quality in mechanically ventilated critically ill patients: a
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51. Treggiari-Venzi M, Borgeat A, Fuchs-Buder T, et al. Overnight
sedation with midazolam or propofol in the ICU: effects on sleep
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Strategies to Facilitate Effective Adoption of the ICU
Liberation Bundle, Measurement of Outcomes, and
Integration Into Clinical Practice
Michele C. Balas, PhD, RN, CCRN-K, FCCM, FAAN,
Paige Donahue, and Nathan E. Brummel, MD, MSCI
Objectives
Present and evaluate strategies to increase ICU Liberation

Bundle implementation.
Identify common barriers and facilitators that clinicians
experience when trying to implement the ICU Liberation
Bundle in practice.
Offer pragmatic suggestions on how to achieve full and
sustained use of the ICU Liberation Bundle in practice.
Key words: ICU Liberation Bundle, implementation, facilitators,

barriers
Knowing is not enough; we must apply. Willing is not enough; we

must do.
—Johann Wolfgang von Goethe
These words ring true for many of the highly motivated, wise, and
compassionate clinicians who have tried to implement the ICU Liberation
Bundle in the ICU setting (Table 1). Since this bundle was first proposed as
an evidence-based conceptual model to reduce the hazards associated with
critical care delivery,1-4 the safety and effectiveness of the bundle have been
demonstrated in numerous research studies, quality improvement (QI)
efforts, and case reports.5-12 Unfortunately, current data suggest that wide-
scale adoption of the bundle remains low, and opportunities to improve
uptake and sustainment of this interprofessional intervention remain.11,13
The disconnect between knowing what to do and actually doing it may
partially be explained by the numerous challenges that clinicians experience
when trying to integrate the bundle into everyday practice. The purpose of
this chapter is to present and evaluate various strategies aimed at increasing
ICU Liberation Bundle implementation, identify common barriers and
facilitators to bundle implementation, and offer clinicians pragmatic
suggestions on how to achieve full and sustained use of the bundle in
practice. We address these issues in a question-answer format
acknowledging what is presently known about the topic and what important
questions remain.
Table 1. ICU Liberation Bundle Components
A: Assessment, prevention, and management of pain
B: Both spontaneous awakening trials and spontaneous breathing trials
C: Choice of analgesia and sedatives
D: Delirium assessment, prevention, and management
E: Early mobility and exercise
F: Family engagement and empowerment
IS ADOPTING THE ICU LIBERATION BUNDLE INTO

EVERYDAY CARE WORTH THE EFFORT?
Any QI effort should begin by answering the rather straightforward
question as to whether the intervention that is being implemented is
evidence-based and associated with improvements in important patient,
family, provider, or health system outcomes. As highlighted throughout this
book, hundreds of studies and QI initiatives demonstrate the benefits of the
individual components of the ICU Liberation Bundle (hereafter referred to
as the bundle). More recently, data demonstrating the benefits of combining
these individual interventions into a “bundled” format have been
published.5-12 The bundle, when implemented into everyday care, is
associated with improved in-hospital and 28-day survival,5,6,10-12 improved
hemodynamic parameters,12 greater ICU physical activity and rehabilitation
efforts,5,7,8 and more patients discharged home from the hospital.11
Moreover, patients spend significantly fewer days on mechanical
ventilation,8,10-12 have less delirium and coma,5-8,11,12 have decreased
pressure ulcers,8 and are less likely to be physically restrained during their
ICU stay.8,11 They spend fewer days in the ICU and in the hospital.8,10-12
After discharge, they have lower ICU readmission rates.11 These studies
also demonstrate a clear “dose-response” relationship between daily bundle
performance and clinical outcomes,6,11 meaning that even imperfect or
incomplete adoption of this evidence-based intervention helps patients.
Importantly, published reports suggest that these important benefits come
with little or no risk of adverse events.5-12
Few studies to date have examined the cost-effectiveness of implementing
the bundle. Preliminary evidence, however, suggests that this intervention
may lead to substantial cost savings.8-10 A single-center study compared
costs between two ICUs, one that implemented ABCDE elements of the
bundle and another that implemented only the A, B, and D elements.8
Although the daily ICU costs did not differ between these two ICUs, the
ICU that implemented the ABCDE portions of the bundle had a 24.2%
lower total ICU cost (95% CI, −41.4% to −2.0%; P = 0.034) and a 30.2%
lower total hospital cost (95% CI, −46.1% to −9.5%; P = 0.007) than the
ICU that implemented A, B, and D only, likely driven by shorter lengths of
stay. In a study in which pharmacists collaborated with interprofessional
teams to manage ICU pain, agitation, and delirium using the bundle, the
reported results were even more impressive.10 This team estimated that the
net impact of the program on hospital expenses included a total savings of
$7.2 million in 2014 (accrual of only 37% of budgeted annual expenses and
generation of 73.3% of projected gross annual savings, with a return on
investment of 13.9). They further projected a savings of $12.3 million in
2015 (projected accrual of 93.2% of budgeted annual expenses and
generation of 129.2% of budgeted gross annual saving, a return on
investment of 9.4). Although savings will no doubt vary from institution to
institution, these data can help clinicians to make the “business case” to
hospital administrators for bundle implementation.
WHAT STRATEGIES AND METHODS HAVE BEEN USED

TO INCREASE BUNDLE IMPLEMENTATION?
We reviewed the published literature describing studies or QI projects
aimed at implementing the bundle.5-10,12,14-19 We chose this approach
because delivering a multicomponent intervention like the bundle presents
challenges specific to the bundle, and therefore unique strategies are needed
to overcome these challenges. It is important to note that no studies to date
have explored the efficacy of interventions to implement the bundle. Rather,
most reports provide a description of the implementation strategies used.
Projects reported using an average of 6 (range, 1-12) discrete
implementation strategies in their implementation efforts. We review the
most commonly used strategies below.
Education
Education was a universal strategy used to increase bundle adoption.5-
10,12,14-19 Most groups reported providing some type of bundle-related
education to members of the ICU interprofessional team (eg, nurses,
advanced practice providers, physicians, respiratory therapists, physical
therapists, occupational therapists, and pharmacists). Education was
delivered in a variety of ways, including onsite and in person during unit-
based meetings, email and asynchronous online training, topic-specific
webinars, peer-to-peer calls, grand rounds via faculty experts, simulation
training, quizzes and case studies, and participation in a learning
collaborative. Educational materials that were disseminated included the
primary studies that demonstrated individual element and overall bundle
safety and effectiveness; Pain, Agitation, and Delirium (PAD) and Pain,
Agitation, Delirium, Immobility, and Sleep Disruption (PADIS) guidelines;
assessment tools that each facility selected to measure pain, level of arousal,
and delirium; the institution’s new bundle policy; the roles that various team
members played in bundle performance and rounding; and posters, flyers,
and bulletin boards describing various bundle elements. The depth and type
of bundle-related educational interventions differed by discipline.
Consistent with bedside nurses’ key role assessing and managing each
bundle element, the most intense educational efforts (in terms of amount
and variety) were directed toward nurses.
As with any multicomponent intervention, the intensity of education
required to facilitate effective bundle implementation should not be
underestimated. It is highly unlikely that a passive and/or single educational
session will lead to optimal bundle implementation. Take, for example, the
amount of training provided to team members who participated in recent
bundle learning collaboratives.15,20 Educational events included 4 or 5, full-
day, in-person training sessions, 10 or more webinars, monthly to bimonthly
peer learning calls, onsite faculty visits, distribution of educational
materials and bundle-related policies, team building, QI and human
performance workshops, education related to evidence-based
implementation strategies, formation of digital community, improvement
advisors, and sustainability training. The healthcare providers who were
trained during the collaborative were then expected to facilitate the learning
of ICU team members at their home institution. Although this “train the
trainer” approach proved effective in implementing the bundle and
improving outcomes, collaborative members reported being surprised at the
amount of time needed for bundle-related teaching at their individual
institutions.
One topic that required extensive training was the assessment of pain, level
of arousal, and delirium. The collaboration trainers reported that the
clinicians’ assessments and the documentation of the assessments were
often inaccurate. To overcome this particular challenge, a multimodal pain,
level of arousal, and delirium assessment training approach such as the one
described by Reimers and Miller18 can be considered. In this approach,
delirium assessment implementation was accomplished by training of super
users, return demonstrations, reminders, competency skills checklists,
observation, and audit and feedback.18 The type of assessment tool training
that providers receive is believed to make a huge difference in terms of
bundle compliance; extended, in-depth education and on-the-job training
achieve higher levels of bundle compliance, at a much faster pace, and with
better results than more passive approaches.20 The use of clinical nurse
specialists and nurse educators as change agents and educational mentors is
also believed to be helpful.18
Formation of an Interprofessional Implementation Team and Plan

Effective bundle implementation requires the buy-in of the interprofessional
ICU team. Most studies report creating an interprofessional implementation
team before beginning any educational, policy, or workflow
change.6,7,10,14,18,20 In general, this team consists of nurses, physicians,
pharmacists, and respiratory, physical, and occupational therapists. The
inclusion of nursing assistants and information technologists as team
members has also proven useful. Together, this team should consider how
key stakeholders may perceive the bundle, the educational strategies used to
foster adoption, how to assess outcomes of importance, and communication
strategies.14 The interdisciplinary team is also ideally suited to identify
bundle champions, review existing bundle-related policies, perform a gap
analysis, coordinate necessary documentation changes, suggest changes to
rounding procedures, assess potential costs, and address other barriers to
bundle implementation.6,14,20
Identification and Preparation of Champions

Champions, or team members who can serve as peer-experts, are important
members of many bundle implementation teams.8,14,15,18-20 Champions are
key liaisons between those with formal organizational change power and
staff members who will make change happen at the bedside. The presence
of champions often makes staff members feel more comfortable to ask
questions and raise concerns. With proper training and motivation,
champions are often ideally suited to lead bundle element-specific
education efforts, perform skills assessments, and monitor compliance with
policy changes. Because these champions are often involved in many QI
initiatives simultaneously, it is important to support them and formally and
informally recognize their efforts.21
Leadership Engagement
The need for active and continual leadership engagement, support, and buy-
in is another important element of bundle implementation.8-10,14,15,20 Key
leaders include the organization’s chief nursing, medical, and executive
officers, director of critical care services, quality and safety managers,
department heads (eg, respiratory, physical, and occupational therapy;
pharmacy), ICU nurse managers, and attending physicians. These key
leaders should be engaged early in the implementation process to ensure
that necessary resources such as information technology support, mobility
equipment, and additional personnel needed for effective and sustained
bundle implementation are available. The expertise of key leaders in similar
implementation projects may also be of benefit, as are their skills in making
the business case for bundle implementation.
Audit and Feedback

Providing clinicians with objective data and feedback regarding bundle-
related process measures and clinical outcomes is a key element of bundle
implementation.9,14,15,20,22 Feedback is important because clinicians may
overestimate actual bundle performance. Auditing can occur in a number of
ways: These include manual chart auditing, observation during
interprofessional rounds, and automated data extraction from electronic
health records. Patient-centered outcomes such as length of stay, time on the
ventilator, and the ability to return home after ICU discharge may provide
the team with important bundle-related feedback measures.
Some elements of the bundle may be out of the team’s control; therefore, it
is important to report bundle-related performance measures that include
both compliance and performance rates. The distinction between using
compliance and performance as process measures, although subtle, is
important. Compliance takes into consideration the results of safety screens
when determining whether the patient receives a bundle-element, whereas
performance takes into account whether a specific element was performed.
For example, a patient receiving a continuous sedative infusion who is
having active seizures and thus meets one of the criteria on an institution’s
safety screen list (eg, active seizures) should not receive a spontaneous
awakening trial (SAT). In this case, because the team performed the safety
screen, the team should be considered compliant with that part of the
bundle. Nevertheless, because the SAT was not actually done, the team
would be counted as not having performed that element.
Performance measures are important when comparing bundle-related
processes across institutions or ICUs where safety screen measures may
vary. Compliance measures are captured more frequently in QI projects.
When the bundle is implemented, both performance and compliance should
be measured to capture the full picture of bundle implementation. This is
because some institutional characteristics, such as overly restrictive safety
screening criteria, could make it appear as though bundle compliance rates
are high even though few patients ever actually receive the intended
evidence-based intervention. However, it would be unfair to not give the
team credit for patient-related factors that preclude bundle-element delivery.
Because there will always be patients for whom bundle-related
interventions are not performed for a good reason, it is highly unlikely that
any ICU will achieve 100% bundle or element-specific performance.
Optimal bundle performance rate (the performance rate at which maximum
clinical benefit is obtained) remains to be determined. Nevertheless, data
show that high rates of bundle compliance are achievable.
Reminders
Clinical reminders can be used to augment the formal and informal
educational efforts described above. Several projects have used this
implementation intervention to foster bundle use.14,15,17-19,23 Some
examples of these reminders include checklists used during bedside rounds,
electronic medical record or documentation prompts, dashboards, red-
yellow-green light alerts, and posters in the break room or restroom.
Although reminders are an easy and near ubiquitous feature in the hospital,
bundle-effort leaders should keep in mind the risk of “reminder” fatigue and
the associated inherent dismissal it may bring.
Mandates for Change

Several teams use the “opt-out” method to optimize bundle
implementation.9,14,18 This means that the default option is for the bundle to
be applied to every adult patient receiving ICU level of care. In other
words, all patients receive all parts of the bundle for which they are eligible
on a daily basis, without the need for a specific order. Should a provider
believe it is not safe or appropriate for a patient to receive a specific bundle
element, the provider would need to provide a written order stating the
patient should not receive that particular bundle element. This particular
implementation strategy has been effective in other areas such as the
number of people who become organ donors.24 This approach, however,
mandates agreement among providers that the bundle is safe, effective, and
relevant to their particular patient population. In other words, it involves a
lot of feedback, collaboration, and communication.
Review of Existing Polices and Documentation Requirements

Prior to implementation efforts, teams should perform critical reviews of
existing bundle-related policies and documentation procedures.8,10,14 These
reviews will help identify which policies need to be updated, streamlined,
or discarded; determine which team members are responsible for delivering
which bundle interventions; determine how process and outcome data will
be collected and recorded; and establish any changes in resources or
equipment that are needed. The findings can also be used to help guide
bundle-related educational activities.
Interprofessional Daily Rounds

As discussed in Chapter 11, the performance of daily interprofessional
rounds can greatly assist with bundle adoption.7,8,10,15 In addition to being a
wonderful time for communicating individual patient needs from different
professional perspectives, interprofessional rounds present a further
opportunity for bundle-related education, data collection, and discussion of
the barriers and facilitators to delivering evidence-based care. The inclusion
of patients and their families in this process can be of particular value. One
strategy that is particularly useful is a structured framework for discussion
provided by the “brain roadmap,” which was originally used to discuss
sedation and delirium but can be easily modified to include other elements
of the bundle.25 The brain roadmap is a quick presentation given by a
bedside caregiver during interprofessional bedside rounds that incorporates
the 3 key components of a patient’s status: Where are they now? Where are
they going? How will they get there? For example, if a patient has a score
of −3 on the Richmond Agitation-Sedation Scale (RASS) but the goal
RASS is 0, and the patient is receiving a propofol drip, the discussion
involves how best to modify the sedation regimen. This conversation allows
the team members to rapidly communicate about the delirium status and
sedation strategy so the team is “on the same page” with regard to
management of these components of the patient’s ICU care. Similar
conversations have proven effective in randomized trials of early
mobility.26
WHAT ARE COMMON BARRIERS AND FACILITATORS

TO EFFECTIVE BUNDLE ADOPTION?
Clinicians can experience many challenges when implementing the bundle
in everyday care. Although some of the barriers may be setting specific,
others transcend institutional boundaries and relate to the physical,
cognitive, and social complexity of this multicomponent, interprofessional,
evidence-based intervention. Table 2 provides a list of common bundle
implementation barriers and facilitators and the reference citations that
describe these barriers and facilitators. Knowledge of which specific
barriers and facilitators exist in real-world ICUs allows for better design
and testing of context-specific implementation strategies and can lead to
more effective bundle implementation.27
Table 2. Additional Barriers and Facilitators of Bundle Delivery
Barriers
Need to obtain order to implement bundle interventions

No interprofessional rounding
Length of time it takes to get policy approval and electronic medical record updates
Lack of patient and/or family cooperation
Staff attitude and lack of buy-in
Exclusion of appropriate ICU team members in implementation process
Unclear protocol and role expectations
Too many policies or policy changes
Lack of accountability
Morale issues
Visitation policy
Outside accrediting institutional policies
Protocol development cost (time and money to develop)
Unit, organizational, patient safety, and quality improvement culture
Physical environment
Lack of equipment and resources
Staff turnover
Low prioritization and perceived importance
Competing priorities and need for further planning
Scheduling conflicts (road trips, patient off unit, patient at dialysis, procedures)
Facilitators
Accessible and clear protocols

Obtaining already developed bundle protocols and “tweaking” them to unit need
Peer advocates
Teamwork
Easily accessible bundle-related supplies and equipment
More ancillary staff (nursing, physical therapy aides)
Mobility teams
Sharing success stories
Stable ICU and implementation leadership teams
Dedicated respiratory and physical therapists
Existing culture of quality improvement
Easy access to training materials
Prompts
Rounding checklists
Developing forcing functions
Making a business case
Implementing all of the bundle elements at once
Act of data collection
Waiting for the right time to “push” implementation
Opt-out method (default is to receive the bundle)
Real-time data collection and feedback
Daily rounds
Work flow revisions
Automated data extraction
Data are from references 6, 9, 10, 14, 15, 17, 18, 20-22, 28-30, 34, 35, 42, and 43.
Communication and Care Coordination Issues

As described above, interprofessional communication is a vital part of
effective bundle implementation.14,15,20,28,29 An essential step to overcome
communication challenges is to clearly define profession-specific roles.28
This can be accomplished by having a written bundle policy that is
accessible to all ICU team members and through formal educational
programs that specifically state what is expected from each team member.
Giving each profession ownership over profession-related elements allows
for best practices to be included in the implementation of each bundle
element while allowing all professionals to recognize that their role is part
of an interconnected team. Prior research suggests that clearly knowing
what role each team member plays in the ICU Liberation Bundle (role
clarity) is associated with less difficulty performing the bundle, better
provider confidence, and a greater sense of bundle safety and strength of
evidence.30
Like any skill, effective interprofessional communication can be learned but
takes practice and training. Offering specific education to ICU teams on
how to engage in truly interprofessional practice and team-based decision
making can facilitate bundle adoption.15,31 For example, in a QI project
involving 7 community hospitals within the Sutter Health System, Barnes-
Daly and colleagues31 specifically cited interprofessional team
collaboration as one of the main driving forces for success. According to
Barnes-Daly and colleagues, the key components for improved patient
outcomes were the interprofessional team model, the training provided to
the unit-based teams, and the opportunity given to team members to
practice and embed the behaviors of collaboration and shared decision
making into everyday practice.
Knowledge Deficits
Although education is one of the most frequently used bundle
implementation strategies, knowledge deficits are one of the most
frequently cited barriers to bundle adoption.15,18,20-22,29,32 The area in need
of most attention entailed educational interventions related to accurately
administering and interpreting the tools used to measure pain, level of
arousal, and delirium. Despite intensive educational efforts in this area,
multiple studies cited questions regarding how to administer these tools
with certain populations (eg, nonvocal patients, patients receiving sedative
infusions, and patients with preexisting neurological injury)15,18,20,21,29,33,34
as common sources of confusion among providers. Thus, educational
interventions can be designed to address these common areas of confusion.
Because providers continue to deem the bundle as relatively complex22 and
ICUs often face high turnover rates,15,18,20,35 those responsible for bundle
implementation efforts have developed a number of novel approaches to
education. These approaches include training on the bundle during
orientation, refresher training, spot checks, educational modules, simulation
exercises, and bundle champions available for help with complex situations.
Perceived Potential Harm and Challenging Populations

Although few adverse events have been associated with bundle elements,
some ICU providers may fear that delivery of this intervention could put
their patients at risk for harm and that it should not be routinely applied to
all patients.14,28,29 For example, providers may fear accidental device
removal (endotracheal tubes, intravascular catheters), falls, and
hemodynamic instability during SATs or early mobility sessions. These
fears are often elevated for vulnerable patients such as those who are
severely ill, are neurologically injured, require mechanical ventilation, are
obese, have open abdomens, or are experiencing severe pain, anxiety, or
fear.28 Nevertheless, these are exactly the patients for whom the bundle may
be the most beneficial. As described throughout this book, a robust body of
literature has demonstrated the safety of these interventions in thousands of
patients. Providing education, sharing success stories, and gaining hands-on
experience by starting interventions with more stable patients at first can
help to overcome the challenge of perceived harm.
Timing of Interventions
When to deliver certain interventions, along with the complexity of
scheduling tasks, is another perceived barrier to bundle
implementation.9,15,28,29,32,33 For example, a common question relates to
the best time to perform SAT and spontaneous breathing trial (SBT)
interventions (eg, early in the morning [during the night shift] or later in the
day). Although different options have been tried, there seems to be growing
consensus that the most important factor to consider is when the provider
who makes extubation decisions will be present. This is important because
if the order to extubate is not placed in a timely manner in relation to a
successful SBT, patients are often not extubated in a timely manner. Similar
challenges are reported regarding mobility, an intervention that often
requires the physical assistance of multiple care providers or needs to be
coordinated around other care activities. Ultimately, solutions for these
problems will need to be tailored to meet the needs of individual health
systems, hospitals, and ICUs. Nevertheless, an overarching principle should
be to create systems that facilitate, rather than hinder, bundle-related
interventions.
Workload and Staffing Issues

A common barrier to bundle implementation relates to workload and
staffing issues.8,10,14,15,20,28,29,35 The perceived workload related to the
bundle can affect bundle delivery.22 For example, delivery of the bundle is
greater on days when a given patient is not mechanically ventilated; this is
related to the reduced number of elements that need to be performed and the
reduced difficulty of intervention delivery (eg, fewer lines and tubes
preventing mobility). Thus, addressing organizational barriers related to
difficulty carrying out the bundle may be one way to overcome less than
ideal staffing. For example, supplies needed to deliver the bundle (eg,
ambulatory bags, ventilator extension tubing, walkers) can be placed in
convenient locations to optimize nurse movement throughout the unit.22
Ultimately, interprofessional teamwork should be emphasized.
Reluctance to Follow Protocols and Guidelines and Inconsistency in

Practice
The reluctance of some physicians (and other ICU team members) to follow
protocols and guidelines is another frequent barrier to bundle
adoption.14,18,20 Although there are many reasons ICU providers may be
reluctant to follow evidence-based recommendations, the main barriers
seem to relate to knowledge (lack of awareness or familiarity with the
bundle and its interventions), attitudes (lack of agreement, self-efficacy
skills, outcome expectancy, motivation), and desire for autonomy.36,37
Given these reasons, education is again a key implementation strategy. For
physicians, active learning from experts as opinion leaders and continuous
medical education have proven useful as educational strategies.36 Using
individualized audit and feedback has been associated with improvements
in physician attitudes.36
Bundle adoption is particularly challenging when there is substantial
practice inconsistency and uncertainty regarding ICU team roles. Little
research to date has explored the specific mechanisms that support care
coordination and teamwork in the ICU setting. Boltey and colleagues38
recently addressed this issue, illustrating the importance of ICU teams
having a “shared mental model” (ie, all ICU team members being “on the
same page”). Routine bundle use was 74% lower (adjusted odds ratio, 0.26;
95% CI, 0.10-0.66) among teams who found it difficult to predict other
team members’ behavior. Thus, using frameworks such as the brain
roadmap presented above can facilitate development of shared mental
models.
Documentation Burden and Electronic Medical Record Challenges

The amount of time spent documenting delivery and patient tolerance of the
bundle and its individual elements evokes concern for many ICU
providers.9,14,15,18,20,34 Providers report deep frustration over not being able
to view bundle-related documentation that was entered by other members of
the interprofessional team, duplication of documentation, and the extended
amount of time it takes to update or create new bundle-related fields in the
electronic medical record. To overcome these challenges, it has been
suggested that teams consider gaining buy-in from senior leadership on the
importance of bundle implementation to secure precious information,
technology resources, understand the different workflows of members of
the interprofessional team, obtain continuous staff feedback on electronic
medical revisions during the development cycle, offer ongoing staff
training, and provide timely reporting on bundle performance.39
Challenges of Obtaining Compliance and Outcome Data and

Administrative Support
As mentioned previously, using audit and feedback is an evidence-based
implementation strategy. Although often effective, this strategy entails
human and financial costs, in that it often necessarily requires medical
record abstraction (either automated or manual) and data transfer, analysis,
interpretation, and feedback. These tasks can be tedious and
underappreciated. To overcome this specific barrier, administrative support
is often deemed crucial.15,18,20,32
SUSTAINABILITY STRATEGIES
Little research has explored how to best sustain the use of evidence-based
interventions in the ICU setting. Moreover, it is unclear how much effort is
needed to sustain bundle implementation. Sustainment, defined in
implementation science as “creating and supporting the structures and
processes that will allow an implemented innovation to be maintained in a
system or organization,”40 can be as challenging as initial implementation
efforts. One systematic review of evidence-based sustainability strategies
found 23 barriers (eg, limited funding, lack of resources, no ability to
modify evidence-based practice) and 26 facilitators (eg, organizational
leadership, training and education, adaption and alignment) of sustainment
efforts.41 Effective sustainment strategies include (1) funding and/or
contracting for continued use of evidence-based interventions; (2)
maintaining workforce skills through continued training, supervision, and
feedback; (3) obtaining continued organizational support; (4) ensuring that
agency priorities and/or program needs align with evidence-based practice;
(5) accessing new or existing money to facilitate sustainment; (6)
maintaining staff buy-in; (7) adapting the intervention to increase
organizational fit; (8) mutually adapting the evidence-based intervention
and the organization; and (9) monitoring effectiveness.
SUMMARY
The ICU Liberation Bundle has demonstrated improvements in outcomes
from hospitals, health systems, and large collaboratives. Although the
improvements in short-term clinical outcomes, reductions in distressing
symptoms, and cost savings associated with bundle implementation are
clear and consistent, many questions remain about how best to implement
this evidence-based interprofessional bundle. Ultimately, solutions tailored
for specific ICUs will be needed. Nevertheless, the tips, tricks, and
strategies presented herein can be used to facilitate effective
implementation. As Goethe reminds us, given the strong evidence behind
the ICU Liberation Bundle, it is no longer enough for us to know—we must
apply and do!
This work was supported in part by the National Heart, Lung, and Blood
Institute of the National Institutes of Health under award number
R01HL14678-01.
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13. Morandi A, Piva S, Ely EW, et al. Worldwide survey of the “assessing
pain, both spontaneous awakening and breathing trials, choice of
drugs, delirium monitoring/management, early exercise/mobility, and
family empowerment” (ABCDEF) bundle. Crit Care Med.
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14. Balas MC, Burke WJ, Gannon D, et al. Implementing the awakening
and breathing coordination, delirium monitoring/management, and
early exercise/mobility bundle into everyday care: opportunities,
challenges, and lessons learned for implementing the ICU pain,
agitation, and delirium guidelines. Crit Care Med. 2013;41:S116-S127.
15. Barnes-Daly MA, Pun BT, Harmon LA, et al. Improving health care
for critically ill patients using an evidence-based collaborative
approach to ABCDEF bundle dissemination and implementation.
Worldviews Evid Based Nurs. 2018;15:206-216.
16. Carrothers KM, Barr J, Spurlock B, et al. Contextual issues
influencing implementation and outcomes associated with an
integrated approach to managing pain, agitation, and delirium in adult
ICUs. Crit Care Med. 2013;41:S128-S135.
17. Negro A, Cabrini L, Lembo R, et al. Early progressive mobilization in
the intensive care unit without dedicated personnel. Can J Crit Care
Nurs. 2018;29:26-31.
18. Reimers M, Miller C. Clinical nurse specialist as change agent:
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19. Sosnowski K, Mitchell ML, White H, et al. A feasibility study of a
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2018;4:32.
20. Carrothers KM, Barr J, Spurlock B, et al. Contextual issues
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integrated approach to managing pain, agitation, and delirium in adult
ICUs. Crit Care Med. 2013;41:S128-S135.
21. Stollings JL, Devlin JW, Pun BT. Implementing the ABCDEF bundle:
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22. Boehm LM. Perceptions of workload burden and adherence to
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27. Weiss CH. Why do we fail to deliver evidence-based practice in
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the ABCDE bundle to minimize adverse outcomes for mechanically
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organizational leadership in system-wide evidence-based intervention
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43. Miller MA, Govindan S, Watson SR, et al. ABCDE, but in that order?
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2015;12:1066-1071.
Post–Intensive Care Syndrome (PICS) and Strategies
to Mitigate PICS
Mark E. Mikkelsen, MD, MSCE, Ramona O. Hopkins, PhD, and Carla M. Sevin, MD
Objectives
Describe post–intensive care syndrome (PICS).

Discuss ways to prevent and treat PICS.
Key words: critical illness, post–intensive care syndrome, long-term

impairments, screening
Advances in critical care medicine have led to improved outcomes; as a

result, most patients will survive their critical illness episode. However,
many survivors do not return to their pre–critical illness functional levels.
Rather, survivors of critical illness often experience impairments in
cognition, mental health, and physical health that endure. Research over the
past 2 decades has increased our knowledge and awareness of these
morbidities after critical illness. Post–intensive care syndrome (PICS), a
term coined in 2012 to raise awareness of these impairments,1 is common
after critical illness.
Specifically, 34% of patients who experience shock and/or require invasive
mechanical ventilation experience cognitive impairment at 12 months at a
level consistent with moderate traumatic brain injury.2 Symptoms of
anxiety, depression, and/or posttraumatic stress disorder (PTSD) afflict
approximately 25% of survivors of critical illness,3 and 27% of survivors
are physically impaired at 1 year after critical illness.4 Together, 56% of
survivors experience a new, enduring impairment in 1 or more of these
domains, and 21% experience 2 or more impairments at 1 year.5 Similarly,
findings from a small telephone-based study that used patient report of
problems found that 54% of patients developed impairments and 56% of
patients had 2 or more impairments after critical illness.6
Related to the 3 domains that define PICS—impairments in cognition,
mental health, and physical health—survivors experience a myriad of
challenges and functional impairments, including pulmonary dysfunction,
particularly among survivors of acute respiratory distress syndrome
(ARDS)7; chronic pain8; sexual dysfunction9; and functional disability
related to contractures.10 These impairments contribute to the reduced
health-related quality of life that has been observed among survivors of
critical illness as well as the inability to return to full-time employment.11
OUTCOMES TRAJECTORIES
Impairments, when measured, are common at the time of ICU discharge. In
one study, 34% of survivors were cognitively impaired to a mild to
moderate degree, and an additional 50% were severely impaired 24 to 48
hours after ICU discharge.12 At hospital discharge, 64% of survivors were
found to be cognitively impaired, when the Mini-Mental State Examination
(MMSE) was used as a screening test, and 57% were impaired at 6 months
when a formal neuropsychological test battery was used.13 However,
cognitive screening tests at hospital discharge did not predict 6-month
cognitive testing. Similarly, data for the ARDSNet Long Term Outcomes
Study (ALTOS) compared performance on the MMSE to a concurrently
administered, detailed neuropsychological test battery. Agreement between
the MMSE was fair and sensitivity was poor when compared with
concurrently administered neuropsychological tests.14 These data highlight
the importance of serial neuropsychological and physical screening
assessments during recovery, paired with formal assessment in those who
screen positive.
Although impairment is common after critical illness, 44% of survivors
without preexisting impairments will be PICS-free at 12 months.5 Survivors
who have higher educational attainment are more likely to be PICS-free,
highlighting the importance of investing in education as a long-term priority
to mitigate PICS in the decades ahead.
RISK FACTORS FOR PICS

As detailed in Figure 1, risk factors for long-term impairments after critical
illness are multiple and include preexisting impairments (ie, frailty), critical
illness itself (eg, inflammation, sepsis), its consequences (eg,
immobilization), and therapies (eg, mechanical ventilation). Mechanical
ventilation, commonly used in ICUs, has been associated with hippocampal
apoptosis through vagal and dopaminergic pathways.15
Figure 1. Elements of critical illness leading to post-intensive care syndrome
Courtesy of Theodore J. Iwashyna, MD, PhD.
Other risk factors identified include hypoxemia,16,17 hypoglycemia,18,19

conservative fluid-management strategy,17 and duration of delirium.2,20
Because glucose and oxygen fuel essential brain functions, avoiding
extreme depletions of these essential nutrients is a reasonable objective
during critical illness to protect long-term brain health.
Given the relationship between early, deep sedation and adverse short- and
long-term survival,21 potentially mediated through duration of delirium,22,23
strategies to prevent delirium, reduce its duration, and avoid excess sedation
are warranted. Notably, concerns that light sedation practices could lead to
neuropsychological harm are unfounded. In fact, light sedation has been
shown either to not be harmful24,25 or to be potentially beneficial to mental
health, as survivors enrolled in the daily sedation interruption and
awakening arm of one study were observed to exhibit fewer symptoms of
PTSD.26 Symptoms of PTSD, likewise, have been associated with
excessive sedation and delusional memories. Strategies to facilitate
formation of factual memories, such as the use of an ICU diary with a
structured debriefing, have been associated with reduced symptoms of
PTSD among survivors.27-29 Because ICU diaries appear to benefit the
mental health of caregivers as well, family-centered care guidelines
recommend the use of such diaries.30 Clinicians should be aware that
corticosteroids, often used for shock reversal, have been found to reduce
PTSD symptoms.31 The implications of unmitigated PTSD reach far
beyond the psychological suffering of patients and families: In a
prospective observational study of cardiac arrest survivors treated in an
ICU, posttraumatic stress symptoms were associated with a significantly
higher risk of death and cardiovascular events within 12 months of hospital
discharge.32
FUNCTIONAL IMPAIRMENTS
As noted previously, physical, cognitive, and mental health impairments are
associated with reduced quality of life, impairments in instrumental
activities of daily living (IADLs), and inability to return to employment.
Poor functional outcomes are common after critical illness and are
associated with impairments in tasks required for living independently, such
as managing finances and medications. A systematic review of 16 studies
assessed IADLs in ICU survivors.33 Of the 16 studies, 11 reported that
survivors had new and/or worsening dependencies in IADLs. No consistent
risk factors were identified for new or worsening IADL dependencies
across studies. The most common factors included older age, impairments
in baseline IADLs, ICU delirium, and duration of mechanical ventilation.
New or worsening IADL dependencies persisted for months after ICU
discharge for most survivors. The relationship between IADL dependencies
and cognitive impairments has not been studied in ICU populations, but in
other populations these factors are associated.33 Intervention studies to
improve IADL dependencies are also needed.
A national multicenter study of 922 previously employed survivors of
ARDS found that 44% were jobless 12 months after ICU discharge.34
Longer hospitalization and older age among nonwhite survivors were
associated with delays in return to work. Of ARDS survivors who returned
to work, 43% worked fewer hours, 27% changed occupations, and 24%
subsequently lost their jobs. Of these patients, 274 had lost earnings
averaging $26,949 ± $22,447 (Mean ± SD), which was 60% of the pre-
ARDS annual income. Survivors who never returned to work had lower
health-related quality of life compared with those who returned to work.34
A meta-analysis of 52 studies in more than 10,000 patients assessed return
to work after critical illness: For previously employed survivors, return to
work occurred in 36% at 3 months, 60% at 12 months, and 68% at 42 to 60
months.35 No difference was found in return to work by diagnosis (ARDS
or not ARDS) or by study region (North America, Europe, or Australia).
After patients returned to work, job loss occurred in 20% to 36% of
survivors, and 5% to 84% worked fewer hours. Other impacts were
unplanned job changes, working fewer hours, and early retirement.
Disability benefits were in effect in 20% to 27% of survivors at 1 year and
59% to 89% at 76 months. Potential risk factors for joblessness were longer
time to return to work, preexisting comorbid disorders, and mental health
impairments after critical illness.35 Intervention studies that include
vocational rehabilitation are needed.
PREVENTION AND MITIGATION OF PICS

After critical illness, many survivors find themselves in a downward spiral,
wherein the inability to return to work results in financial hardship, which
has psychosocial ramifications.36 The impact extends to caregivers, who
frequently provide care assistance for the survivor, exacerbating the
financial shock felt by many.11
Despite these realizations, issues of survivorship are rarely addressed
during or after the ICU stay,37 leaving survivors and their caregivers
unprepared for the future that awaits. Survivors are resilient,6 and
education, support, and empowerment are key facilitators to recovery.6,38
As described below, a key strategy to mitigate PICS is to inform survivors
and their caregivers about PICS and proactively assess for PICS to identify
impairments that require services, including rehabilitation.
In light of this emerging evidence supporting the prevalence and severity of
PICS, efforts have been made both to prevent PICS and to treat PICS and
its sequelae after the ICU. Strategies to mitigate PICS can be considered
from several different perspectives.
First, PICS prevention begins with strategies to prevent critical illness and
to lessen its impact. For example, timely access to effective medical care
could prevent as many as 250,000 ICU admissions annually in the United
States, as ICU admissions were preceded by an ambulatory-care sensitive
condition in 16% of ICU admissions.39 Separately, public awareness
campaigns, like “Stop Sepsis, Save Lives,” with an emphasis on
vaccinations, could prevent millions of patients over the next decade from
developing PICS by preventing critical illness.40 At the end of life, through
increased use of advanced care planning and palliative care, patients who
express goals and preferences that do not align with high-intensity care will
avoid the ICU. In addition, years of education has been associated with an
increased likelihood of being PICS-free5; thus, social investment in
education has additional benefits.
Second, PICS prevention is dependent on ICU care delivery that accounts
for PICS risk factors and is designed to maximize the likelihood of
maintaining functional independence. PICS risk factors are numerous. As
detailed in Figure 1, critical illness entails intrinsic hazards, including
immobilization and sedation, consequences of the catabolic,
proinflammatory state, and physiological derangements (eg, hypoxemia,
hypoperfusion, glucose dysregulation) and conditions (eg, delirium). The
ICU Liberation Bundle41,42 is a PICS prevention bundle (Table 1).
Table 1. Elements of the ICU Liberation Bundle
Assessment, prevention, and management of pain
Both spontaneous awakening trials and spontaneous breathing trials
Choice of analgesia and sedation
Delirium assessment, prevention, and management
Early mobility and exercise
Family engagement and empowerment
Third, strategies to assess, prevent, and manage pain and delirium are
interrelated keys to PICS prevention. Likewise, the choice of sedation is
key, because certain interventions (ie, benzodiazepine infusions) are
associated with delirium development. In the landmark awakening trial by
Kress and colleagues,43 sedation interruption resulted in fewer midazolam
equivalents (229.8 mg in the sedation interruption group vs 425.5 mg in the
control group); as a result, the interruption group spent 2.4 fewer days on
the ventilator and 3.5 fewer days in the ICU and were significantly more
likely to be discharged home (59% vs 40%). When spontaneous awakening
trials (SATs) and spontaneous breathing trials (SBTs) were implemented in
a coordinated fashion, patients spent approximately 3 fewer days on the
ventilator and in the ICU, experienced less coma, and were significantly
more likely to be alive at 1 year.44
Fourth, early mobilization in the ICU has several short- and long-term
benefits. In the short-term, patients receiving early physical and
occupational therapy had shorter duration of ICU delirium by 2 days;
duration of mechanical ventilation was also reduced.45 Further, return to
independent functional status at hospital discharge was more frequently
realized by patients in the early physical and occupational therapy arm
(59% vs 35%).45
Fifth, attention must be paid to the effects of critical illness and critical care
after the ICU, where early intervention in the posthospital period may
mitigate some of the aspects of PICS. This is an area only beginning to be
explored, and more data are needed. However, early evidence suggests that
coordinated, knowledgeable implementation of multidisciplinary
posthospital care for ICU survivors could result in improved outcomes,
including fewer readmissions.46-50 Attempts to identify at-risk patients and
target specific complications of critical illness have thus far included
development of screening tests, attention to discharge planning, care
coordination interventions, primary care interventions, telephone
interventions, post-ICU clinics, cognitive rehabilitation, and peer support.
SCREENING AND IDENTIFICATION

Although much is known about the pre- and in-ICU risk factors
predisposing to the development of PICS, there is yet no validated tool or
consensus to identify patients at risk for PICS or those who may benefit
from intervention. A self-report version of the Healthy Aging Brain Care
Monitor has been studied as a potential clinical tool for this purpose, but it
was developed for an older population and may be limited by the self-report
aspect, especially the cognitive domain, which did not correlate with formal
measures of cognitive function such as the Repeatable Battery for the
Assessment of Neuropsychological Status (RBANS).51 Poor awareness of
deficit is a common finding in the post-ICU population, hampering efforts
to identify patients at risk by using surveys. Application of an automatically
calculated readmission risk score for the purpose of identifying patients
who need further attention and intervention has not been shown to be useful
in ICU survivors, as such scores may fail to identify previously healthy
patients for whom the critical illness represents their first serious healthcare
episode.52 In the absence of validated clinical tools for identifying at-risk
patients, clinicians engaged in post-ICU care most often use clinical criteria
based on known risk factors to identify patients at risk for sequelae,
including the presence of mechanical ventilation, shock, delirium, and/or
length of stay.
DISCHARGE PLANNING
Attention to specialized discharge planning for survivors of critical illness is
likely an underappreciated intervention that can be integrated into existing
care pathways and delivered in the hospital (Table 2). In a recent
randomized study implementing an ICU recovery bundle for high-risk
patients, delivery of outpatient portions of the intervention was limited.46
The inpatient portions of the bundle consisted of an inpatient visit from an
ICU nurse practitioner, an educational brochure about PICS, and medication
reconciliation. Although only 12.6% of intervention patients received an
outpatient intervention, a significant reduction was seen in the composite
outcome of death or readmission within 30 days of hospital discharge (18%
vs 29.8%; P = 0.04) compared with patients who did not receive any
components of the bundle (both groups received medication reconciliation
from an ICU pharmacist), suggesting that the educational visit and brochure
may have had a significant impact on outcomes. When survivors of critical
illness and their families are asked about the posthospital recovery period,
frustration with lack of communication and information about the recovery
trajectory is among the most common themes.6
Table 2. Examples of Advice from Former ICU Patients and Families to Medical Professionals
1. Discharge orders: Patients and families need a more detailed explanation of what to expect physically,
cognitively, and mentally. There needs to be more “soft talk” about potential after-effects with patients and
family. Treatment plans should include protocols for how to deal with cognitive and mental challenges.
Patients and families need a “cliff notes” version of the discharge papers.
2. Normalizing: Patients and families need to know that it is normal or ok to seek mental health support after
ICU discharge. Doctors should make referrals.
3. Education: Families need more education about what to expect so they understand why the patient changed.
This could lessen the tension and stress of the recovery process.
PERIHOSPITAL CARE COORDINATION

INTERVENTIONS
Due to the high risk of complications in the post-ICU population, attempts
have been made to implement care coordination or disease management
interventions in the perihospital period. In a prospective study, intensive
care patients who received more than 3 days of mechanical ventilation at a
university medical center were randomized to usual care or 8 weeks of case
management and interdisciplinary communication provided by advanced
practice nurses.53 Most patients were discharged to an extended care
facility; only 22.8% were discharged directly to home. The investigators
noted no significant difference in survival, health-related quality of life, or
functional status, but survivorship cost less with the intervention than
without the intervention, and readmission duration was decreased, resulting
in an average savings of $19,705 per patient.
PRIMARY CARE AWARENESS AND INTERVENTIONS

In the United Kingdom, national guidelines recommend long-term
monitoring and follow-up for survivors of critical illness. However, most
countries have failed to adopt similar guidelines, and professional society
recommendations are lacking at this time. In the absence of clear care
pathways, the burden of post-ICU care has fallen on primary care
physicians (PCPs). Although often familiar with the medical and social
histories of their patients and skilled in care coordination, PCPs are given
no specific training in the care of ICU survivors and the problems unique to
this population. In addition, although millions of patients survive a critical
illness each year, a typical PCP may only see 1 or 2 of these patients,47
providing PCPs with little clinical experience to allow them to identify and
treat post-ICU complications. Qualitative evidence supports this idea: PCPs
do not often feel confident in their abilities to recognize and treat post-ICU
complications.48 Additional training and support for PCPs conducting post-
ICU care have been suggested, but no established programs are in
practice.49 Attempts to assist PCPs by educating them about post-ICU
complications in survivors of sepsis and providing specific case
management did not change mental health–related quality of life (the
primary outcome), but a trend toward better physical recovery was
observed. In addition, the intervention group had fewer sleep impairments
and a greater improvement in symptoms of PTSD.50,53
Information transfer from the inpatient to the outpatient setting is a barrier
to optimal care by PCPs. Furthermore, the problems of ICU survivors are
vast and may require significantly more time than allotted for a typical
posthospitalization visit. Although some additional reimbursement is
available in the United States for complex posthospital care (transitional
care codes), no specific code or care model is available for post-ICU
syndrome. Thus, reimbursement is likely insufficient for the resources
required to adequately care for ICU survivors in the primary care setting.
POST-ICU CLINICS
Chiefly described and implemented in the United Kingdom and
Scandinavia,54-56 dedicated post-ICU clinics are most often team clinics
dedicated to subspecialty outpatient follow-up of patients who have been
critically ill. In the United Kingdom and Europe, these clinics have been
nurse led. In the United States, this model of care has been growing despite
financial barriers.57 Patients, families, and healthcare systems have
perceived benefits to ICU-specific follow-up after critical illness, according
to the Collaborative Assessment of ICU Recovery Needs (CAIRN) study
(ClinicalTrials.gov Identifier NCT03513289). But barriers remain, not least
due to a paucity of data about unmet needs after an ICU admission.58
Much of the available data examine sequelae of specific ICU diagnoses,
such as sepsis. Like ICU survivors in general, sepsis survivors are at high
risk for posthospital complications and may benefit from targeted outpatient
intervention after discharge. The risk of readmission is especially high in
this group: Readmissions commonly exceed 40% in the first 3 months after
hospital discharge, and 42% of these were found to be potentially
preventable with timely and appropriate outpatient therapy.59 In a recent
study, delivery of recommended postsepsis care elements—medication
optimization, screening for functional or mental health impairments,
monitoring for common and preventable causes of health deterioration, and
documentation of goals of care—was associated with reduced morbidity
and mortality following a sepsis hospitalization.60 A prospective,
comparative effectiveness analysis of Medicare data showed that the
combination of early and intense home health nursing visits and early
physician follow-up after a hospitalization for sepsis reduced the probability
of 30-day readmission by 7 percentage points.61 In a retrospective
comparison of resource utilization before and after an ICU stay in a US
healthcare system, ICU survivors had significantly increased resource
utilization in the year after critical illness, but only 8% received new
support in the form of physical therapy, occupational therapy, or cognitive
or mental health treatment in the post-ICU period.62 In that cohort, no
association was found between a non-ICU-specific outpatient visit within 2
weeks of discharge and resource utilization, suggesting that specific ICU
recovery services are needed to provide the right care at the right time in
order to affect posthospital outcomes for ICU survivors.
Delivery of ICU-specific follow-up care by critical care–trained clinicians
in the outpatient setting, known as a post-ICU clinic, ICU follow-up clinic,
or ICU recovery program, was first explored in the United Kingdom, where
this model of care has gained wide acceptance and health system support.63
Adaptation in the US health system has been slower, perhaps in part due to
lack of awareness of the problem, a paucity of data regarding effective
interventions, and structural and financial barriers to designing and
implementing new models of care, especially in the outpatient setting
(Figure 2). Despite these challenges, several US centers have described
their experiences designing, implementing, and sustaining post-ICU
clinics.64,65 As touched on above, a randomized trial of an ICU recovery
bundle, which included posthospital phone and email contacts as well as a
post-ICU clinic visit, showed that such an intervention was feasible, and
although patient engagement in the outpatient portion of the intervention
was low, a combined readmission and mortality outcome was decreased in
the intervention group.46 In these pragmatic, single-center, clinical cohort
studies, the prevalence of new impairments in physical function, cognition,
and affect, as well as socioeconomic challenges such as inability to return to
work and increased healthcare resource utilization, have mirrored or
exceeded those seen in the sepsis and ARDS literature.
Figure 2. Summary of key enablers and barriers to implementing ICU follow-up clinics and peer support
programs
Reproduced with permission. Haines KJ, et al. Enablers and Barriers to Implementing ICU Follow-
Up Clinics and Peer Support Groups Following Critical Illness: The Thrive Collaboratives. Crit Care
Med. 2019;47:1194-1200. Copyright © 2019 by the Society of Critical Care Medicine and Wolters
Kluwer Health, Inc. All Rights Reserved.
In an effort to accelerate new knowledge regarding the implementation of

ICU survivorship programs, the Society of Critical Care Medicine fostered
the Thrive Collaboratives. Some early data from these groups suggest that
the potential benefits of providing ICU recovery services affect not only
patients and families but also clinicians and hospital systems. As described
in an international qualitative study of ICU clinicians, patients, and
caregivers, post-ICU programs can drive improvement in the ICU by
identifying targets for quality improvement or education, creating new roles
for survivors as patient advocates and peer mentors, motivating clinicians,
changing clinicians’ understanding of the patient experience, and improving
morale in ICU work.66 Additional information regarding post-ICU clinic
design and implementation is anticipated from the Thrive collaboratives. In
the meantime, several studies examining alternative means of delivering
outpatient interventions to this high-risk, impaired population—including
telemedicine and mobile ICU recovery—are underway (ClinicalTrials.gov
Identifiers NCT03926533 and NCT03053245).
PEER SUPPORT
Peer support is mutual or unidirectional support from nonprofessionals with
similar stressors or health problems, which can be provided in person, by
telephone, or on the internet.67 Peer support, used successfully outside of
critical care to improve health outcomes when paired with education, could
promote health among survivors of critical illness through role modeling,
information sharing, and providing practical advice from those who have
experienced critical illness.68 For example, peer support increased social
connectedness, feelings of group belonging, and coping for day-to-day
changes in individuals with mental illness.69 A systematic review of peer
support for ICU survivors concluded that peer support may reduce
psychological morbidity, improve social support, and improve self-efficacy
among survivors of critical illness and their caregivers,67 yet confirmatory
studies are needed. Further, although multiple models of peer support exist,
including online models, it remains unclear which approach works best for
survivors.70 One promising strategy, used in the Intensive Care Syndrome:
Promoting Independence and Return to Employment (InS:PIRE) program
in Glasgow, Scotland, and the Vanderbilt ICU Recovery Center in
Nashville, Tennessee, is to partner peer support with ICU follow-up clinics.
The Society of Critical Care Medicine Thrive International Peer Support
Collaborative gathered data on the models being used, in order to categorize
differences between the models, and described facilitators and barriers of
implementation of peer support.70 Seventeen sites from the Thrive Peer
Support collaborative were included. An iterative process was used to
identify key areas of peer support along with barriers and challenges to
implementation. Six models of peer support were identified: peer support
within the ICU, community-based models, psychologist-led outpatient
models, within-ICU clinic models, peer mentor models, and online peer
support. Common barriers of peer support implementation included
recruitment of participants, training and input of peer support personnel,
funding, risk management, and sustaining the program over time, all of
which need to be addressed in implementation of a peer support program. In
addition, all of the peer support models struggled with how to measure their
effect on patients and family outcomes and what metrics to use to evaluate
success. Although peer support models are being used, no data are available
showing their effectiveness in ICU populations. However, these models
have been shown to be effective in other populations. Additional research in
this promising area is needed.
PSYCHOLOGICAL INTERVENTIONS
To date, few studies have focused on interventions to improve distress and
psychological outcomes after critical illness. Coping is a conscious effort to
control, minimize, or tolerate stressful situations, and coping skills or
strategies can be taught. Cox and colleagues71 developed and evaluated a
telephone-based coping skills training intervention and showed that it
reduced depression, anxiety, and PTSD symptoms in ICU survivors of acute
lung injury. A randomized controlled trial that compared telephone and
web-based coping skills training versus an education program found that
the coping skills training intervention did not reduce depression, anxiety, or
PTSD in ICU survivors at 3 or 6 months.72 However, in patients who had
high levels of baseline distress, the coping skills training reduced symptoms
of depression, anxiety, and PTSD and increased health-related quality of
life at 6 months compared with the education program. In patients who
underwent mechanical ventilation and had longer ICU stays, the education
program improved distress at 3 months but not at 6 months.72 Investigations
are needed to determine when coping skills training and educational
programs may benefit patients.
Cognitive behavioral therapy is often recommended as a first-line treatment
for PTSD symptoms in other populations. In non-ICU populations,
exposure therapy or a combination of exposure with cognitive behavioral
therapy has been shown to be effective.73 Cognitive behavioral therapy is
also widely used to treat depression and anxiety. A study in ICU survivors
used a brief cognitive behavioral psychoeducation program to manage
stress and anxiety in family caregivers of ICU patients; the group receiving
the intervention was compared with a no-intervention group.74 The
cognitive behavioral psychoeducation intervention reduced stress, anxiety,
and depression and increased satisfaction in family caregivers. Cognitive
behavioral therapy is a promising treatment for survivors of critical illness,
but no studies have been conducted to date.
COGNITIVE REHABILITATION
Intervention to improve cognitive impairment is an important and growing
area of research. One way to improve cognitive outcome is by focusing on
factors associated with cognitive impairments. A review of 28 studies
assessing potentially modifiable risk factors for cognitive impairments after
critical illness found that delirium, glucose dysregulation (hypoglycemia or
hyperglycemia), and hypoxia were potentially modifiable risk factors in the
development of cognitive deficits after critical illness.75 A systematic
review and meta-analysis of 6 randomized controlled trials found that early
rehabilitation improved short-term physical-related outcomes and decreased
ICU-acquired weakness but did not improve cognitive function (measured
as cognitive-related delirium-free days) compared with standard care or no
early rehabilitation.76
Another way to improve cognitive function is by using cognitive
rehabilitation; this entails interventions targeted at improving cognitive
impairments that arise after critical illness due to brain damage. Cognitive
rehabilitation has several approaches, including use of strategies or
compensatory mechanisms to minimize weaknesses or maximize strengths
and use of computerized cognitive rehabilitation via brain-training
computer programs (like conventional video games) to improve or restore
cognitive function. A study in 34 ICU survivors who underwent 6 weeks of
cognitive rehabilitation in combination with combined strength training and
walking found a significant improvement in cognitive function compared
with controls.77 A study of 21 general medical ICU survivors used a
program of cognitive, physical, and functional rehabilitation for 12 weeks.78
At baseline there was no difference in cognitive function between the 2
groups. At the 3-month follow-up, the intervention group showed
significant improvement in executive function and IADLs compared with
the control group.78 Both studies used a combined cognitive and physical
intervention, so it is unclear whether physical rehabilitation, cognitive
rehabilitation, or both contributed to improved cognitive function.
Using a complex multifaceted intervention, Zhao et al79 randomized ICU
survivors to a twice-weekly, 12-week intervention consisting of learning to
play an electronic musical keyboard (30 minutes); learning simple Spanish
(30 minutes); memorizing a clock, including time, shape, style, and
background (10 minutes and then reproduce the clock); and talking to a
psychiatrist for 30 minutes. No difference was noted in baseline cognitive
function between the 2 groups. At 3-month follow-up, cognitive impairment
occurred in 59% of the intervention group and 82% of the control group.
Younger patients had better cognitive outcomes compared with older
patients.79 Taken together, the 3 studies described above provide support for
the use of cognitive rehabilitation in ICU survivors.
Computerized cognitive rehabilitation has also been used to improve
cognitive outcome in ICU survivors. A pilot study used computerized
cognitive exercises in 20 patients admitted to the ICU.80 The patients
received a daily 20-minute session of computerized cognitive exercises,
which increased in difficulty as the training progressed. Patients were able
to complete 87% of the possible cognitive exercise sessions and reported
that they enjoyed the sessions and found them relaxing; the cognitive
training did not cause undue fatigue. No cognitive exercise session was
stopped for patient safety, and no adverse events were reported.80
A second computerized cognitive rehabilitation pilot study consisted of
adaptive exercises to optimize speed and memory.81 Thirty-three ICU
survivors completed 7 cognitive exercises daily, 5 days a week for 12
weeks. Baseline computerized cognitive rehabilitation scores were
compared with the postintervention scores and showed significant
improvement over time. The amount of improvement in cognitive function
was positively correlated with the number of hours of cognitive
rehabilitation training. No differences were found in pre- compared with
postintervention neuropsychological test scores, and the study was likely
underpowered to detect such a difference. These data suggest that
computerized cognitive rehabilitation interventions may be a promising
way to improve cognitive outcomes after critical illness. Importantly,
computerized cognitive interventions require less face-to-face interaction
with clinical professionals compared with standard cognitive rehabilitation
methods.81 Additional research is needed to determine whether
computerized cognitive rehabilitation improves cognitive function in
survivors of critical illness.
SUMMARY
Posthospital care of ICU survivors remains both a challenge and an
opportunity. The mandate to optimize critical illness recovery with tailored
survivorship programs seems clear. Additional research and clinical
experience are needed to further delineate the needs of ICU survivors and
develop effective interventions to mitigate the effects of PICS, with the goal
of maximizing recovery after critical illness.
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891.
Use of an Interprofessional Team Model in the ICU to
Facilitate Performance of the ICU Liberation Bundle
Mary Ann Barnes-Daly, MS, RN, CCRN-K, DC, and Juliana Barr, MD, FCCM
Objectives
Discuss issues of rounding logistics and operations that

incorporate interprofessional involvement.
Highlight roles and contributions of each team member.
Review common challenges and barriers to implementing
effective and efficient interprofessional rounds.
Key words: bundle, interprofessional, critical care, ICU Liberation,

collaboration
In this chapter, we review the characteristics and qualities of critical care

teams and team members and the extent to which interprofessional
collaboration, communication, and care coordination contribute to the
successful implementation and performance of the ICU Liberation Bundle.
INTERPROFESSIONAL TEAMWORK—
COMMUNICATION AND COLLABORATION
Teamwork is defined as the way in which a group of individuals work
together in a coordinated fashion to reach common goals.1 The presence of
a multidisciplinary critical care team has been associated with better patient
outcomes and reduced healthcare costs.2 The degree to which these care
team members communicate and collaborate has also been shown to affect
patient outcomes and, as such, should be considered an important factor in
the successful implementation and sustainability of the bundle.
Competencies related to interprofessional collaborative practice are often
neither known, taught, nor measured. The ability of specific team members
to work together collaboratively and to communicate effectively is
paramount. Table 1 lists and describes these core competencies.3
Table 1. Competencies for Interprofessional Collaborative Practice
Competency Description
Values, ethics Works with individuals of other professions to maintain a climate of mutual respect and
for shared values.
interprofessional
practice
Roles and Uses the knowledge of one’s own role and those of other professions to appropriately
responsibilities assess and address the healthcare needs of the patients and populations served.
Interprofessional Communicates with patients, families, communities, and other healthcare professionals in a
communication responsive and responsible manner that supports a team approach to the maintenance of
health and the treatment of disease in patients.
Teams and Applies relationship-building values and the principles of team dynamics to perform
teamwork effectively in different team roles and to plan and deliver patient/population-centered care
that is safe, timely, efficient, effective, and equitable.
Adapted from Interprofessional Education Collaborative Expert Panel. (2011). Core Competencies
for Interprofessional Collaborative Practice: Report of an Expert Panel. Washington, DC:
Interprofessional Education Collaborative.
The distinction between a multidisciplinary team in which most or all of the

members possess these competencies versus one in which members do not
is an important one. In the previous edition of this book, in the chapter
describing the role of the interprofessional team (IPT) as it relates to bundle
compliance, differences between a multidisciplinary team (MDT) and an
IPT were elucidated.4 The MDT model is described as a “consultative”
model, one in which team members, acting as consultants, each provide
information to a lead clinician, typically the intensivist or other physician,
who in turn makes all care decisions and enters orders that are followed by
the remaining team members. By contrast, in the IPT model, each team
member functions in a discrete professional role that includes patient
assessment and the report of these findings, but the model goes further to
encourage care recommendations from each discipline, which are then
considered by the team. In the IPT model, each team member is recognized
and respected as an expert in their specialty, thus optimizing each team
member’s expertise and contribution toward collaborative decision making,
as each has an equal voice in the creation of the patient’s care plan.4
INDIVIDUAL AND TEAM ROLES IN BUNDLE

PERFORMANCE
Table 2 shows the typical roles and responsibilities of team members for
each bundle element. The specialty with primary accountability performs
the assessment and/or provides the intervention associated with each of the
bundle elements, while additional team members provide necessary or
required contributions via coordinated assistance, oversight, consultation,
and/or order entry.
Table 2. ICU Liberation Bundle Elements—Team Responsibilities
Bundle Element Primary Additional Team Member

Accountability Responsibility
A Assessment, prevention, and management of pain RN Physician, Pharm
B Both spontaneous awakening trials and RN, RCP Physician, Pharm, RN

spontaneous breathing trials
C Choice of sedation and analgesia Physician RN, Pharm
D Delirium assessment, prevention,

RN RCP, Pharm, Physician, Rehab
and management
E Exercise and early mobility Rehab, RN RN, RCP
F Family engagement and empowerment RN, Fam All
G Good sleep RN Physician, Pharm, RCP, Fam

Abbreviations: Fam, family or significant person, including patient when possible; Pharm,
pharmacist or PharmD; Physician, intensivist, specialist, hospitalist, or other attending; RCP,
respiratory care practitioner; Rehab, physical therapist and/or occupational therapist; RN, registered
nurse.
These functions can be delegated or, more commonly, shared; for example,
the respiratory care provider (RCP), pharmacist, or physician may choose to
perform the assessment for level of sedation because it relates to their
bundle function. Ultimately each team member can contribute broadly to
the completion of these bundle activities, and the entire team should assume
responsibility for ensuring that all appropriate bundle elements are
completed on each ICU patient every day. Although individual bundle
elements can theoretically be executed independently of one another on a
given patient, the interdependency of the bundle elements (eg, a
mechanically ventilated patient typically needs to be awake and alert in
order to successfully pass a spontaneous breathing trial [SBT] or to achieve
the highest possible level of mobility each day) highlights the importance of
engaging the entire team to deliver these evidence-based practices in an
integrated fashion.
The complexity of the bundle, and its nearly universal application to all
ICU patients regardless of the need for ventilatory support, create unique
challenges to bundle integration efforts. Clinicians who choose to
implement a complex quality improvement initiative like the ICU
Liberation Bundle should consider the extent to which ICU
interprofessional teamwork is required for success and sustainability of the
bundle.5,6
THE ROLE OF INTERPROFESSIONAL TEAM ROUNDS

Communication and collaboration between ICU team members are essential
components of optimal care throughout the patient’s entire ICU course. The
opportunity to share information and to adapt the plan of care accordingly is
inherent in the process of daily ICU rounds. The diversity that exists in
critical care teams in different care settings informs the structure and
function of rounding in the ICU. The complexity of care provided in ICUs
varies across patient populations and ICU types, but such care typically
involves multiple disciplines, specialists, and subspecialists. The amount of
time each team member spends with a patient varies considerably as well;
bedside ICU nurses spend the most time with patients, whereas the time
spent on direct patient care activities can vary considerably between
physicians, respiratory therapists, pharmacists, and other team members.
Certain team members’ workflows may not be conducive to spending long
periods of time on ICU rounds. In larger facilities, particularly those with
multiple specialty consultants and/or subspecialty team rounds, it may be
impractical to include all clinicians in IPT rounds that address all bundle
elements on a daily basis.7,8 But clear improvements have been
demonstrated in the quality of patient care when ICU rounding teams
include at least an intensivist, the patient’s primary nurse, a pharmacist, and
a respiratory care practitioner.9,10 As described above, these core members
of the ICU care team are the clinicians primarily responsible for the
delivery of the ICU Liberation Bundle elements and as such may have the
greatest impact on bundle utilization and support of IPT rounds.11,12
Intensivist participation in IPT rounds improves patient care delivery and
outcomes, regardless of whether intensivist involvement in patient care is
mandatory or consultative.10,13 In ICUs without intensivists, the presence of
a hospitalist or other type of attending physician who is primarily
responsible for the patient’s care is essential during IPT rounds. Physicians
lead and facilitate team communication; daily care plan development; and
the safe, regular, and consistent deployment of bundle elements in support
of optimal patient care. Medical residents and fellows, as well as ICU
advanced practice providers (APP), who are directly involved with making
decisions, writing orders, and executing the daily care plan specifically
related to bundle elements, are also important participants in IPT rounds.14
Physicians leading rounds can model IPT principles by eliminating the
traditional hierarchical structure of ICU rounds that often prevents other
disciplines from contributing optimally. The physician can accomplish this
by asking each discipline for input and recommendations for care during
rounds and facilitating a team-based discussion to evaluate these
suggestions. Team-based decision making and care planning are important
determinants of bundle performance in the ICU.15
The ICU bedside nurse typically spends more time providing direct patient
care than any other member of the ICU team. This role gives the bedside
nurse a unique perspective and insight into the patient’s current condition,
treatment responses, care preferences, and outcome expectations, making
the bedside nurse’s involvement in IPT rounds essential. The bedside nurse
is also responsible for performing several bundle elements: assessing pain,
sedation, and delirium; evaluating sleep quality; and applying-
nonpharmacological and pharmacological interventions to prevent and treat
pain, optimize sedation, and reduce delirium in patients. The bedside nurse
also commonly coordinates SBTs and spontaneous awakening trials (SATs)
with the RCP and mobilization efforts with the rehabilitation specialist.
The presence of critical care pharmacists on IPT rounds can reduce adverse
drug reaction occurrence, lower ICU mortality, improve ICU care delivery,
and reduce overall costs.9,16 Pharmacists add value to IPT rounds by
reconciling medications, optimizing drug dosing, eliminating unnecessary
costly or high-risk medications, and resolving issues related to drug-
shortages. Most important, pharmacists can support ICU Liberation Bundle
utilization by helping to develop effective pain and sedation protocols that
reduce the use of deliriogenic medications as well as guiding the de-
escalation of analgesic, sedative, and antipsychotic medication use by
recommending multimodal strategies to meet analgesia and sedation targets
that are specific to each patient.
Respiratory care practitioners (RCP) who practice in the ICU possess the
knowledge, skill, and experience to address the complex respiratory care
needs of critically ill patients. RCPs work both independently and by
partnering with the intensivist or pulmonologist to determine which
mechanical ventilation strategies, oxygen delivery systems, and pulmonary
treatments will optimize patient outcomes. The RCP participating in IPT
rounds can help to ensure that respiratory care data are accurately reported
and used to develop a daily respiratory care plan for each patient.17 RCPs
are typically responsible for screening the patient and coordinating the
SAT/SBT with the bedside nurse, assisting physicians in evaluating patients
for extubation readiness by performing an SBT, and discussing the SBT
results with the ICU physician and care team. The RCP can also help to
identify patients at high risk for failed extubation and may suggest bridging
strategies that can prevent the need for reintubation. RCPs often play a key
role in facilitating and coordinating the safe and effective mobilization of
mechanically ventilated patients with the bedside nurse and/or rehabilitation
personnel.
The participation of a rehabilitation clinician, either a physical therapist
(PT) or an occupational therapist (OT), on ICU IPT rounds can help
facilitate early patient mobilization and rehabilitation of patients. PTs and
OTs can help to evaluate patients’ prehospital mobility and functionality to
create realistic mobility and activity goals for patients during their stay in
the ICU. PTs can help to identify and overcome mobilization barriers and
educate and train other team members on how to safely mobilize patients
with or without a therapist present.12,18-20 Low PT staffing levels that
preclude their daily participation in IPT rounds may be a significant but
modifiable barrier to mobilization efforts.19 Effective communication and
collaboration between the bedside nurse and the PT are fundamental to a
successful ICU early mobility program. The process and documentation for
an ICU early mobility program should include a mobility eligibility safety
screen, mobility start and stop criteria, and a mobility progress assessment
tool.21
Engagement of ICU patients and their families in team discussions and care
planning and processes creates a more patient-centered approach to care.
This practice also increases patient, family, and staff satisfaction; improves
outcomes; and reduces costs.22 SCCM’s Guidelines for Family-Centered
Care in the Neonatal, Pediatric, and Adult ICU recommend that patients and
family members be offered the option of routinely participating in ICU
rounds.23 Difficult and potentially life-altering decision making often falls
to family members because many ICU patients are too ill to participate in
rounds-based discussions about care plans and goals of care.24 Because
family members are often patients’ healthcare surrogate decision makers,
the information provided by patients’ families and loved ones should
always guide the team’s clinical decision making and goals of care
discussions. Family and patient participation in ICU rounds benefits
clinicians by facilitating discussions of the patient’s wishes, contributing
information about aspects of the patient’s past medical history, and
facilitating medication reconciliation efforts.25-28 Family observation of
daily IPT rounds and the reasoning behind assessments, interventions, and
plans for the day helps make the ICU experience less overwhelming and
more transparent to patients and families.
Empowering families to be advocates for their family member and to
participate in their loved one’s care facilitates their integration into the
larger care team. Specifically, the bundle affords opportunities for family
involvement in patient care activities including, but not limited to, delirium
mitigation, coaching during SBTs, and aiding in exercise and mobilization
efforts.21,5,29
SUMMARY
Implementation of the ICU Liberation Bundle has the ability to
dramatically transform patient care, improve outcomes, and reduce
healthcare costs for critically ill patients. Performance of the bundle has a
dose-response effect on patients, with better bundle performance translating
to even greater improvements in outcomes and reductions in cost. But the
complexity and universal applicability of the bundle to all ICU patients
require interprofessional communication, collaboration, and care
coordination between all members of a multidisciplinary ICU team. This
often requires a significant transformation in the way that teams function in
the ICU. The IPT model is the hallmark of high-performing ICU teams who
consistently and accurately apply the bundle to all ICU patients in a timely
fashion, achieving the triple aims of lowering ICU costs, improving ICU
patient experiences, and enhancing ICU population health.
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2. Weled BJ, Adzhigirey LA, Hodgman TM, et al. Critical care delivery:
the importance of process of care and ICU structure to improved
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and Family Empowerment” (ABCDEF) bundle. Crit Care Med.
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Implementation of the ICU Liberation Bundle:
Collecting and Using Data for Quality and Performance
Improvement
Brenda Pun, DNP, RN, FCCM, and Pat Posa, RN, BSN, MSA, CCRN-K, FAAN
Objectives
Describe how to collect data regarding use of the ICU

Liberation Bundle.
Discuss how to enhance performance improvement of the ICU
Liberation Bundle.
Key words: ICU Liberation Bundle, ABCDEF Bundle, ICU,

implementation, quality improvement, delirium, mobility, sedation,
pain
ICU patients often experience the failure of multiple organ systems while
battling debilitating infections and systemic reactions. Although research
has immensely advanced our ability to care for these patients, it has also
taught us the short-term and long-term dangers of pain, delirium, and deep
sedation. However, the translation of research to evidence-based practice
often lags many years, if not decades. The ICU Liberation (ABCDEF)
Bundle concept arose from the need to align these evidence-based
interventions and assessments within a framework to improve
communication and collaboration and ultimately facilitate the adoption and
sustained implementation of evidence-based practice at the bedside.1,2
Bundles have been shown to improve survival in severe sepsis, decrease
ventilator-associated pneumonias, and reduce central line infections3,4 and
have been hallmark features of the Institute for Healthcare Improvement’s
(IHI’s) 100,000 Lives and subsequent 5 Million Lives campaigns.5,6 The
ICU Liberation Bundle has been no exception to this trend, with numerous
studies reporting improved patient outcomes with bundle compliance and
performance.7-10
The IHI introduced the concept of bundling recommendations nearly 20
years ago in order to enhance teamwork and communication.11 The ICU
Liberation Bundle provides a framework for deploying multiple
recommendations from clinical practice guidelines and improving care for
all critically ill patients.12,13 However, integrating this bundle into everyday
practice can be challenging. This chapter focuses on how to enhance
performance improvement of this bundle. The IHI’s Model for
Improvement will be used to describe important implementation concepts
as they relate to the bundle. Additionally, we describe how to collect, track,
and interpret performance data for the bundle.
IHI MODEL FOR IMPROVEMENT

The IHI’s Model for Improvement is a framework used to successfully
implement change in an organization. The model is based on 3 key
questions:
1. What are we trying to accomplish?

2. How will we know that a change is an improvement?
3. What changes can we make that will result in an improvement?
These three questions are combined with the Plan-Do-Study-Act (PDSA)

cycle to complete the model. The PDSA cycle is a method to implement a
new change, evaluate it, and guide the formation of ideas and testing. Each
of the 4 parts represents steps of the process: determining a change (Plan),
implementing it (Do), evaluating it (Study), and modifying it (Act). These
steps help to keep projects continually moving forward through a cycle of
improvement.14
Build the Right Team
An interprofessional team must be formed to guide, develop, and oversee
the implementation of the ICU Liberation Bundle. This team should include
representatives from all of the disciplines involved in the care of critically
ill patients (Table 1). The ICU Liberation Bundle does not focus on one
specific organ system, infection type, or disease process. Rather, the bundle
is applied to interventions for all types of critically ill patients and focuses
on minimizing pain, agitation, delirium, and sleep disruption while
maximizing alertness, mobility, and family engagement. The elements of
the bundle involve multiple members of the critical care team and require
communication and coordination. Therefore, it is important that the bundle
implementation team include a stakeholder from all the involved
professions. This allows for multiple perspectives to be represented and a
team approach planned.
Table 1. Interprofessional Team Members and Key Stakeholders for Implementation of the ICU Liberation
Bundle
Critical care intensivists and physicians
Medical leadership/physician leaders
Nursing leadership (managers, clinical nurse specialists, educators)
Bedside nurses
Respiratory therapists
Physical therapists
Occupational therapists
Speech therapists
Pharmacists
Patients and family members
Quality or continuous improvement staff
Model for Improvement Step 1: What Are We Trying to Accomplish?

As you begin the improvement work, it is important to understand why a
change is needed. The literature describes the negative short- and long-term
sequelae for patients with critical illness who have unmanaged pain,
oversedation, delirium, immobility, and disrupted sleep.12,15,16 Although a
strong foundation of evidence supports the individual elements of the ICU
Liberation Bundle,2 multiple studies have examined the relationship of the
bundle implementation and patient outcomes. In a single-center before-after
study of 296 patients, Balas et al7 reported that patients in the
postimplementation period spent fewer days on the ventilator, experienced
less delirium, and had more out-of-bed mobilization. Barnes-Daly et al8
reported that increasing bundle compliance in 6,064 patients from 7
community hospitals was significantly associated with fewer days of
delirium, fewer days of coma, and improved hospital survival. Building on
this work, the ICU Liberation Collaborative, using data from more than
15,000 patients and 68 ICUs, reported that bundle performance was
associated with fewer days of mechanical ventilation, coma, delirium, and
restraint use as well as higher likelihood of hospital survival.9 Multiple
studies have demonstrated that these outcomes are dose dependent (the
more bundle elements performed, the better the outcomes).8-10 Full bundle
implementation has been shown to decrease total hospital costs by more
than 30%.10 From single-center studies to nationwide collaboratives have
come consistent reports of patient improvement with the ICU Liberation
Bundle.
The first step of any bundle implementation program should be to ensure
that the concept of the bundle is integrated into the culture and language of
the unit. This helps the interprofessional team, the patient (as he or she is
able), and the family to understand that these elements are interrelated and
synergistic. Ways to promote the concept of the bundle include using
bulletin boards or posters to introduce the bundle and describe what each
element represents, offering unit-wide education such as journal clubs
where science supporting the bundle is reviewed, updating the scripts and
goals checklists used in rounds to include the ABCDEF language, and
updating the electronic health record (EHR) to have the same language. The
initial push for this education can be simple and fun, allowing for materials
to be updated over time. All units will have some degree of the elements
already in place; in this foundational step, it is important to link those
elements with the others that are in the bundle. This helps prevent the
siloing of individual elements (eg, a stand-alone sedation weaning protocol
that uses a sedation scale but does not include mobility or breathing trials).
Adopting the ICU Liberation Bundle’s ABCDEF language is a foundational
step that allows the interprofessional team to keep the big picture in mind
and reminds them that the whole is more powerful than the sum of the parts.
Model for Improvement Step 2: How Will We Know That a Change Is

an Improvement?
To define what you are trying to accomplish with your improvement efforts,
you need to understand what your current practices are compared with the
best practices in the literature. There are multiple ways to evaluate your
baseline practice (eg, performing a gap analysis, collecting baseline data). It
is important to involve representatives from all members of the
interprofessional team. Evaluating your baseline from multiple perspectives
allows you to identify areas where misses and near misses are happening.
One way to evaluate current practices is to “walk your process.” This
process involves physically walking through the processes of patient care in
your ICU related to management of pain and sedation, liberation from the
ventilator, delirium prevention and treatment, mobilization, and sleep
promotion. This is an information-gathering stage that involves attending
rounds, talking to staff, and asking why some things work and other things
do not work. Performing a gap analysis is another strategy to identify which
of the bundle related evidence-based practices are not being performed in
your unit (Table 2 provides an example). This allows you to document your
overall goals and determine which ones you already meet.
Table 2. Sample Gap Analysis for the ICU Liberation Bundle
Yes No
1. Does your unit use specific tools to assess pain in patients who cannot self-report? □ □
CPOT
□ BPS
2. Does your unit have specific pain management protocols in place for the following?
Assess pain ≥4 times per shift and as needed. □ □
Define significant pain with NRS >3, BPS >5, or CPOT ≥3. □ □
Treat pain within 30 minutes of detecting significant pain and reassess. □ □
Offer nonpharmacological treatment (eg, relaxation, distraction). □ □
Administer preprocedural analgesia and/or nonpharmacological interventions (treat pain □ □

first, then sedate).
3. Does your unit have a protocol in place to accomplish a coordinated

□ □
SAT/SBT?
4. Does your unit have a sedation protocol in place and manage sedation proactively to □ □
decrease use of continuous sedation?
5. Does your unit perform daily SATs and SBTs, including the following?
SAT: Use the least amount of sedation necessary to achieve respiratory stability, patient □ □
safety, and minimal anxiety.
SAT: Have a protocol that promotes the goal of a calm and awake patient. □ □
SAT: Use a sedation scale such as RASS or SAS to assess sedation level and achieve □ □
sedation goals.
SBT: Nurses and respiratory therapists collaborate to perform spontaneous breathing trials □ □
in coordination with spontaneous awakening trials.
6. Has your unit successfully implemented a delirium assessment tool with successful and □ □
correct performance of delirium assessments? CAM-
ICU
□
ICDSC
7. Does your unit use a specific tool to assess sedation-agitation? □

RASS
□ SAS
8. Does your unit use an analgesia and sedative algorithm to control pain first, and then anxiety, □ □
and use intermittent medications first before continuous medications?
9. Is your target RASS 0 to –1 or SAS 1? □ □
10. Does your unit have an early mobility protocol in place? □ □
11. If yes, who initiates the mobility protocol?

Nurses □ □
Physical therapists □ □
Both nurses and physical therapists □ □
12. Does your unit implement early mobility interventions on a daily basis, including the
following?
Active range of motion □ □
Bed exercises □ □
Dangle legs at side of bed □ □
Stand □ □
Active transfer □ □
March in place □ □
Walk in room □ □
Walk in hall □ □
13. Does your unit have a process in place to identify the frequency for review of care and
required documentation for the following?
Elevation of the head of bed □ □
Tidal volume (in mL/kg) □ □
Daily SAT □ □
Daily SBT □ □
Regularly scheduled oral care including deep oropharyngeal suctioning □ □
Patient mobility and activity □ □
Abbreviations: BPS, Behavioral Pain Scale; CAM-ICU, Confusion Assessment Method for the
Intensive Care Unit; CPOT, Critical-Care Pain Observation Tool; ICDSC, Intensive Care Delirium
Screening Checklist; NRS, Numeric Rating Scale; RASS, Richmond Agitation-Sedation Scale; SAS,
Sedation-Agitation Scale; SAT, spontaneous awakening trial (daily sedation interruption); SBT,
spontaneous breathing trial.
Collecting a sample of data on how consistently patients are receiving all of

the interventions for which they qualify is essential. This allows you to
mark baseline performance and thus measure improvement as you
implement various PDSA cycles. Identifying metrics that will help establish
baseline performance and objectively track progress is key. From the
experience of the ICU Liberation Collaborative, the Society of Critical Care
Medicine (SCCM) created a minimum data set (MDS) and toolkit for the
ICU Liberation Bundle
(https://www.sccm.org/ICULiberation/News/Download-the-ICU-
Liberation-Toolkit). This MDS identifies compliance metrics for each
element of the bundle. The accompanying toolkit is intended to further
equip interprofessional critical care teams to measure their performance
improvement. The sections cover data and compliance definitions, provide
a spreadsheet for data collection, and give recommendations for data input
and compliance reports. The toolkit also explains how to understand and
use the data for continuous process improvement.
Metrics are important for helping teams understand what is being done in
terms of the bundle elements, equipping teams to answer the question “Are
we making improvement?” The challenge is pulling the patient data for
these metrics from the medical record. Some EHR systems can pull data for
specific variables and create dashboards that display data in aggregate form,
allowing for quick visual referencing of current status and progress. The
benefit of having a dashboard that is taken directly from the EHR is that the
process is not limited by manual data entry error or time restraints. Data can
be extracted easily for a few patients or a large number. However, many
institutions do not have the technical support for the creation of such
dashboards or the EHR does not document the data for each element in a
way that is easy to retrieve for such a report. The SCCM’s MDS tool
includes the suggested metrics for each bundle element as well as a
Microsoft Excel tracking tool that has built-in graphs that populate when
data are entered (Figure 1). The downside to using this type of tool is that it
relies on additional data collection and entry, which can be time-consuming,
prone to human error, and difficult to sustain. Whatever method is used, as
the IHI model emphasizes, identifying metrics and tracking them are
essential in improvement work. This process allows all stakeholders, from
the unit leadership to bedside staff, to see the impact of change efforts
toward established goals.
Figure 1. Types of improvement trends. (A) Upward trend; (B) downward trend; (C) plateau trend
Model for Improvement Step 3: What Changes Can We Make That Will
Result in an Improvement?
Once the concept of the ICU Liberation Bundle has been accepted in a unit,
stakeholders can begin to create a strategic improvement plan. Although the
approach will be different for each unit, some common elements will
contribute to success. This is a key step where baseline data can be very
helpful in developing priorities. These data will help units to evaluate the
effectiveness of elements that are already part of care practice. These data
will also serve as a benchmark for improvement. Unit leaders may decide to
start with an element that is new for them or an element that has been in
place but needs a little tweaking for better success. One strategy is to set
growth benchmarks for each element (eg, if at baseline no element is up to
50% compliance, a reasonable goal would be to have all elements at or
above 50% compliance in 3 months).
Goal setting should be done collaboratively with all the stakeholders from
the interprofessional team. Although the ultimate goal is for every patient to
receive every eligible component of the bundle every day, this goal may
take a while to achieve. It is useful to set some interim goals that can be
celebrated along the way (Table 3). Typically, 80% to 85% compliance
rates that are sustained indicate that a new procedure has been adopted into
practice. On the way to adoption, keep in mind (and remind your teams)
that nearly all of the research studies of this bundle have shown that
additional improvement in compliance and performance yields additional
improvement in patient outcomes.8-10 Compliance of 60% is better than
30%, and 80% is better than 60%. Goals can be set for full bundle
compliance and for each individual element. Short-term goals can help you
move up the mountain of improvement and provide “wins” along the way
to celebrate. An example of progress or relative goal is to improve 20% in
all bundle elements in 2 months. Communicate the goals and progress to the
entire staff by means such as bulletin boards (hallway or breakroom),
newsletters, or staff-wide emails. Celebrate reaching goals with things like
pizza parties, bagel breakfasts, cakes, and/or drawings for gift cards. Last,
inform superiors (eg, medical directors, hospital administrators) when goals
are reached (even short-term goals). This is a great way to gain recognition
for the staff at a higher level and provide objective data to justify resource
requests.
Table 3. Types of Goals
Goal Type Description

Ultimate goal Every patient, every day = 100%.
Progress These are short-term goals for increased compliance relative to baseline; for example:
“relative” goals
In 2 months, our goal is to improve 20% in all bundle elements.
In 3 months, we want to improve 30% in the overall bundle compliance.
We are aiming for 3 straight months above 70% compliance.
Adoption goal Typically, 80%-85% compliance rates that are sustained ( >3 consecutive months) indicate
that a new protocol has been adopted into practice.
PLAN, DO, STUDY, ACT CYCLES

Once goals are in place, the IHI Model for Improvement’s PDSA cycle
serves as a helpful framework for implementing the continuous quality
improvement plan. This process helps teams stay on track and in forward
motion. Here is a breakdown of those phases as they apply to implementing
the ICU Liberation Bundle. Additionally, an example of PDSA cycles as
they relate to the bundle is found in Table 4.
Table 4. Plan-Do-Study-Act Example
What are we trying to Increase amount of out-of-bed mobility in the ICU.

accomplish?
How will we know that a Document the percentage of patients per month who mobilize.
change is an improvement?
What changes can we make Implement a mobility protocol.

that will result in an
improvement?
Plan: Develop a plan to test the Meet with an interprofessional team that includes all stakeholders
change. (eg, nurses, doctors, rehabilitation therapists, respiratory therapists,
pharmacy staff).
Review the mobility protocol.
Brainstorm and plan screening and stopping criteria; outline roles
and responsibilities.
Discuss communication and coordination challenges.
Create a plan to implement a mobility protocol.
Set a goal to mobilize one patient in the next week.
Look for an “easy win.”
Do: Execute a small test of Actively screen the unit for a relatively healthy, stable patient to start
change. the mobility protocol who will likely be able to walk in the ICU.
From admission throughout the week, apply the protocol to the
patient and progress the patient as applicable.
Study: Set aside time to Meet with the team and debrief the experience.
analyze the data and study How did the protocol hold up during screening? Were criteria too
results. restrictive? Were any too specific? Were any too vague?
How were the communication and coordination with nursing and
rehabilitation team?
How was the protocol integrated into rounds? Was daily progress in
the protocol discussed?
What was the patient’s and family’s experience?
What could be improved?
What was the documentation experience like?
Act: Refine the change, based

on what was learned from the Modify the protocol as needed:
test. Adjust screening criteria.
Adjust stopping criteria.
Modify the communication and coordination plan as needed.
Modify the discussion on rounds as needed.
The first step in this cycle is to plan the change you are testing. The work
that has been done up to this point will provide the basis for this step. All
the baseline data that have been gathered will guide your team in creating a
plan to begin the implementation work. This is when a small workgroup
decides the details of the proposed change: Who? What? When? Where?
Often, the proposed change will involve modifying existing policies,
procedures, and protocols. In this phase, the team also makes predictions
about what will happen with this change.
The “Do” phase is where the change happens. At this point, the change can
be small and can focus on a small number of patients. Next, the change is
further improved and rolled out to more patients. After more improvements,
the change is eventually rolled out to the whole unit.
In the “Study” phase, the quality improvement team analyzes the baseline
data, reviews the predetermined metrics, and makes observations. The team
compares the results with their predictions, asking questions such as “Do
we have the type of improvement we thought would happen with this
change?” This learning turns to action in the next phase.
In the “Act” phase, teams translate the observations to modifications of the
change with questions like “Given these data, what do we need to change?”
Having a dashboard, regardless of whether it is embedded in your EHR,
SCCM’s MDS, or another system, is essential for tracking progress.
As mentioned above, the dashboard data help to establish a baseline and
track trends. When evaluating trends, it is often helpful to consider data in
3-month intervals. Evaluating several months at a time helps avoid the
influence of outliers. This does not mean that smaller intervals cannot be
examined with small tests of change evaluations. However, larger time
spans are more helpful when considering trends of improvement. Similarly,
consider something a trend only if it has happened 3 months in a row.
Apply this same rule when deciding whether you have sustained
achievement of certain goals. For example, if your next goal is 80%
compliance, look for 3 months in a row where the compliance is more than
80%. Three consecutive months at your goal gives an indication that true
change is happening versus a temporary fluctuation. You can still celebrate
the first time you get to 80%—just wait until you have 3 months in a row to
celebrate sustained work at that level. Three types of trends (ie, upward,
downward, and plateau) are discussed below.
Upward or improvement trends are those that entail at least 3 months of
increasing compliance (example in Figure 1A). This type of trend indicates
that your efforts are working. Improvement trends indicate there is
movement toward full adoption. Celebrate and communicate these trends.
Let the staff know their hard work is paying off, and let administrators
know that this program is headed in the right direction. Keep cheerleading
the efforts, and remember that while this indicates sustained improvement,
you have not yet reached your ultimate goal. Downward or regression
trends are those that show at least 3 months of decreasing compliance
(Figure 1B). Plateau trends (Figure 1C) are when there is no movement, up
or down, for 3 months. These types of trends indicate that changes in your
implementation strategy and techniques are needed. Sometimes additional
data are needed. Perhaps the data set that is populating your dashboard does
not capture the root of the problem. You may need a “deeper data dive.”
Some frequent barriers involve EHR record displays, education, and
staffing perceptions.17,18
Often EHR systems have built-in qualities that prohibit communication and
coordination (eg, screens are hidden from certain views, or the system
doesn’t capture the right information). Staffing and/or equipment may be
insufficient (or may be perceived to be insufficient). There may be an
education deficit among types of staff or individual staff. The staff may not
be comfortable with safety criteria or stopping criteria. The deeper
investigation could include auditing patients’ charts to better understand
circumstances. Polling staff members (informally or formally) and asking
about barriers and roadblocks is an additional way to gather data. Be sure to
include all the interprofessional staff members involved. If you are
collecting data on a limited number of patients, consider expanding this
number to ensure that outliers (sicker or healthier patients) are not skewing
your report.
Specifically, the plateau trend could indicate that further compliance will
require bigger changes in the unit structure. For example, a plateau could
indicate that more equipment and/or staff members are needed. If this is the
case, the dashboard data can provide a powerful tool for advocating with
the senior leadership for resources. You can use the tool to show progress
and plateau. You can communicate unit-wide engagement that has stalled
without more resources. Additionally, this may be an important time to
reevaluate the screening and stopping criteria that you are using for
spontaneous awakening trials, spontaneous breathing trials, and early
mobility. Are these criteria too restrictive? Are they too loose? Do staff feel
uncomfortable or unsafe performing the interventions? Last, plateauing
frequently happens above the 90% mark. At this point, the macro changes
have been adopted to unit practice, but there may be certain patient
populations or specific staff members who are noncompliant. Auditing the
noncompliant patient charts can help you better understand the barriers and
needs in these situations. Seek to identify the late adopters and meet with
them to better understand their positions.
SUMMARY
The ICU Liberation Bundle has been shown to be a powerful tool in
advancing and improving patient care. This bundle requires all members of
the critical care team to communicate and coordinate activities, and thus
members from each of those groups should be part of implementation
planning. The IHI’s Model for Improvement can serve as a framework for
implementing the bundle into bedside clinical practice. Having a way to
monitor performance, through use of tools like the SCCM MDS, is
necessary to drive continuous improvement.
REFERENCES
1. Vasilevskis EE, Ely EW, Speroff T, et al. Reducing iatrogenic risks:
ICU-acquired delirium and weakness—crossing the quality chasm.
Chest. 2010;138:1224-1233.
330.
3. Chamberlain DJ, Willis EM, Bersten AB. The severe sepsis bundles as
processes of care: a meta-analysis. Aust Crit Care. 2011;24:229-243.
4. Resar R, Pronovost P, Haraden C, et al. Using a bundle approach to
improve ventilator care processes and reduce ventilator-associated
pneumonia. Jt Comm J Qual Patient Saf. 2005;31:243-248.
5. Berwick DM, Calkins DR, McCannon CJ, et al. The 100,000 lives
campaign: setting a goal and a deadline for improving health care
quality. JAMA. 2006;295:324-327.
6. McCannon CJ, Hackbarth AD, Griffin FA. Miles to go: an introduction
to the 5 Million Lives Campaign. Jt Comm J Qual Patient Saf.
2007;33:477-484.
7. Balas M, Vasilevskis EE, Olsen KM, et al. Effectiveness and safety of
the awakening and breathing coordination, delirium
monitoring/management, and early exercise/mobility (ABCDE)
bundle. Crit Care Med. 2014;42:1024-1036.
10. Hsieh SJ, Otusanya O, Gershengorn HB, et al. Staged implementation
of awakening and breathing, coordination, delirium monitoring and
management, and early mobilization bundle improves patient
outcomes and reduces hospital costs. Crit Care Med. 2019;47:885-893.
11. Resar R, Griffin FA, Haraden C, et al. Using Care Bundles to Improve
Health Care Quality. IHI Innovation Series white paper. Cambridge,
MA: Institute for Healthcare Improvement; 2012.
Med. 2018;46:e825-e873.
2017;45:103-128.
14. Institute for Healthcare Improvement. Plan-do-study-act (PDSA)
worksheet.
http://www.ihi.org/resources/Pages/Tools/PlanDoStudyActWorksheet.a
spx. Accessed November 10, 2019.
16. Shehabi Y, Bellomo R, Reade MC, et al. Early intensive care sedation
predicts long-term mortality in ventilated critically ill patients. Am J
17. Stollings JL, Devlin JW, Pun BT, et al. Implementing the ABCDEF
bundle: top 8 questions asked during the ICU Liberation ABCDEF
Bundle Improvement Collaborative. Crit Care Nurse. 2019;39:36-45.
18. Balas MC, Pun BT, Pasero C, et al. Common challenges to effective
ABCDEF bundle implementation: the ICU Liberation Campaign
experience. Crit Care Nurse. 2019;39:46-60.
Administrators’ Perspectives
on the ICU Liberation Bundle
Jaspal Singh, MD, MHA, MHS, FCCM,
Erika Gabbard, DNP, RN, CCNS, CCRN-K, Yasaman O. Back, MS,
and George E. Ross, MBA, HCM, CPHQ
Objectives
Describe the business principles behind an ICU Liberation

program.
Highlight resources and financial strategies needed to support
and sustain the program.
Describe strategies for effective communication including use
of the electronic health record.
Keywords: critical care, business, length of stay, ventilators,

mechanical, delivery of health care, mortality, delirium
A multicomponent liberation and animation strategy for patients in the ICU

aimed at reducing delirium and weakness has been proven effective in a
variety of ICU settings.1,2 Liberation refers to reducing exposure to
mechanical ventilation and sedative medications using coordinated, target-
based sedation protocols, spontaneous awakening trials (SATs) and
spontaneous breathing trials (SBTs). Animation refers to early mobilization,
which reduces delirium. This evidence-based strategy was originally
referred to as the ABCDE bundle: Awakening and Breathing Coordination,
Delirium monitoring/management, and Early exercise/mobility. This bundle
was adopted in 2015 for a large-scale quality improvement project led by
the Society of Critical Care Medicine (SCCM). Since that time, the bundle
has been modified and has incorporated newer guidelines related to family-
based care3 and most recently Sleep Medicine Practices.4 As described in
previous chapters, the ICU Liberation bundle incorporates elements of
analgesia, breathing, choice of sedation strategies, delirium, early
mobilization, and family engagement in a more synchronous fashion
through daily interprofessional care rounds of the ICU patient. The SCCM
quality improvement project coordinated the bundle implementation across
80 ICUs in North America. Although the bundle has been shown to be
effective in isolated ICUs, unique aspects of coordination, education, and
implementation were discovered.5 Moreover, complete bundle performance
was associated with lower likelihood of six outcomes: hospital death within
7 days, next-day mechanical ventilation, coma, use of physical restraint,
ICU readmissions, and discharge to a facility other than home. In addition,
a dose-response relationship was found between bundle performance and
outcomes.6
In the adoption of the bundle across small and large healthcare institutions,
several issues arise in the implementation process. Certain aspects pose
particular challenges for specific teams, units, institutions, and
organizations. In this chapter we highlight these issues while proposing
alternative means to overcome these challenges. Moreover, we provide an
administrative lens to the issue with the goal to emphasize the partnership
between bedside clinicians and their administrators. We ultimately make the
case that such adoption has advantages in operational, financial, and service
domains.
OPERATIONAL IMPACT OF THE BUNDLE
Workforce Impact
Intensive Care Physicians (Intensivists)
There is a national and worsening shortage of intensive care physicians,7,8
and although a number of solutions have been proposed to address this
shortage,9 it has resulted in a crisis for some of our hospitals. As such,
having an intensivist-led team places challenging demands on intensivists
regarding pressure to be present simultaneously at the bedside during
emergencies, in different hospital locations, and during team-based rounds.
As well, teaching and workforce responsibilities limit resident duty-hours,
such that the workload might shift to the attending,10 thus adding to the
limited availability of the bedside intensivist. Since many intensive care
physicians in the United States also have mixed pulmonary and office
responsibilities outside of the ICU,8 this creates additional difficulty in
synchronizing team-based rounds. We have observed this at our large
healthcare system, whereby rounds had to be adjusted in timing, scope, and
practice to the needs and desires of the leading intensive care physician. In
some instances, team-based rounds do not occur with regularity due to the
lack of desire by the intensivist to have these performed, leading some ICUs
to have rounds led by advanced practice providers, nursing staff,11 and
others without intensivist involvement. Hospitals that have trouble
recruiting a stable physician workforce thereby will have challenges
mandating physician-led team-based rounds. That being stated, a number of
hospitals round without an intensivist at the bedside, realizing that the
intensivist’s lack of availability can impede otherwise consistent staffing
and implementation of daily goals of care. Although we believe that
intensivists’ roles in ICUs have major advantages in optimizing team-based
care, we have begun to proceed with team-based rounds in some of our
ICUs even when intensivists are not available. The latter is done simply to
ensure that other aspects of care coordination, resource allocation, and
patient safety are attended.
Nurses
Shortages in nursing in critical care12 have also posed challenges to team-
based rounds and other aspects of ICU Liberation. To adjust for the
shortages, hospitals have had to increase the number of patients cared for by
nursing staff, thereby limiting the ability of a nurse to care for the complex
needs of an individual patient. Moreover, new graduates in critical care may
have difficulty transitioning to critical care practice,13 and we believe that
in our ICUs, the ICU Liberation Bundle helps these recent graduates by
providing structure in the bedside goals that align with institutional goals.
From a hospital administrators’ perspective, improving the performance and
integration of new nursing graduates is an imperative that cannot be
understated because this aligns with the need to minimize turnover and
increase retention of experienced staff.
Pharmacist Extension
Much evidence supports the roles and expertise of critical care
pharmacists.14,15 However, in many hospitals critical care pharmacists are
not available due to lack of staffing models that incorporate these
professionals. We have noted that our ICU Liberation Bundle, which was
developed and implemented in concert with our critical care pharmacists,
has extended the expertise and scope of our current critical care
pharmacists. These pharmacists developed protocols limiting the choice of
sedation, worked with our electronic medical record (EMR) teams to create
distinct restrictions and warnings to clinicians prescribing benzodiazepine
infusions, and helped to standardize some of our previous approaches to
sedation, agitation, and delirium consistent with the PAD guidelines.
By no means is the ICU Liberation Bundle a replacement for bedside
critical care pharmacists rounding in the hospital, but in hospitals that do
not have such a resource, the ICU Liberation bundle with pharmacist input
serves as some means of goal alignment and process standardization.
Physical and Occupational Therapy Coordination of Services

Early mobilization of ICU patients and involvement of physical therapy
(PT) and occupational therapy (OT) have been demonstrated to provide a
net benefit in a number of studies (reviewed by Adler and Malone16), even
in patients receiving mechanical ventilation.17 Key lessons arise related to
organizational processes in such work to optimize patient safety and
performance when early mobilization is employed,18 but by and large the
net benefits of early involvement by PT and OT can be quite remarkable.
That said, significant staffing and economic challenges are related to PT
and OT involvement in the ICU, which have posed a direct hindrance to
effective and sustainable implementation of this across a broad range of
ICUs.
Our strategy for implementation of the ICU Liberation Bundle was directed
toward which domains of mobilization were best managed by nursing staff
versus those best managed by bedside specialists in this space (Figure 1).
Delineating this has been helpful to clarify roles and expectations.
Figure 1. Stepwise approach to early mobility
Abbreviations: AROM, active range of motion; ECG, electrocardiographic; HOB, head of bed; OT,
occupational therapy; PEEP, positive end-expiratory pressure; PROM, passive range of motion; PT,
physical therapy; RASS, Richmond Agitation-Sedation Scale.
Respiratory Therapy Care and Coordination

The benefits of coupling awakening and breathing trials for patients
receiving mechanical ventilation have been known for quite some time,19
but many hospitals and healthcare systems have struggled to implement
this. Timing of awakening trials, physician preferences, risks of self-
extubation, and staffing coordination have impeded the ability to
consistently operationalize standard processes. Implementing the bundle
has catalyzed institutional efforts to create a more standardized protocol for
managing awakening and breathing trials (Figure 2).
Figure 2. Coupling of Spontaneous Awakening Trial (SAT) and Spontaneous Breathing Trial (SBT)
Abbreviations: BP, blood pressure; GCS, Glasgow Coma Scale; HR, heart rate; ICP, intracranial
pressure; I:E, inspiratory-expiratory; PEEP, positive end-expiratory pressure; RASS, Richmond
Agitation-Sedation Scale; RR, respiratory rate; Spo2, oxygen saturation.
Integration of Electronic Medical Records, Patient Safety, and Quality

Use of the ICU Liberation Bundle has facilitated the use of rounding tools
across our healthcare system. We struggle as others do to find tools that are
pragmatic, integrated with the daily workflow, and able to integrate with the
EMR. Moreover, each ICU is different in a healthcare system, such that
tools and processes that work in one ICU are difficult to transfer to another.
By using the ICU Liberation bundle we were able to approach unification
of a mission across our ICUs in a manner that we struggled with earlier. Use
of the bundle set the tone for standardization of workflow and processes for
measuring sedation, agitation, and delirium scales, and by having the work
of SCCM associated with this, we found it easier to achieve buy-in from
our units and staff.
We were able to work with our EMR vendor (Cerner) to develop a rounding
view and worksheet to facilitate the ICU Liberation rounding process,
including piloting a physician documentation tool. Further iterations of this
process are in development, but the ICU Liberation campaign served as a
catalyst to develop this work. It forced us to examine and overcome barriers
in awakening trials, breathing trials, sedation, analgesia, delirium, and other
practices and to measure our performance in these aspects.
From an administrator’s perspective, use of the ICU Liberation bundle was
effective in aligning our organization’s education of the ICU staff,
extending our workers’ expertise, and measuring effectiveness of our
patients’ journeys through the ICU. Attention to outcomes, quality, costs,
and patient safety across a broad geography and institutional diversity is of
great value to healthcare systems and their respective staff and patient
populations.
OUR INSTITUTIONAL APPROACH

Our healthcare system (Atrium Health) is a large healthcare system in the
southeast United States, headquartered in and around Charlotte, North
Carolina. We sought to pilot the ICU Liberation Bundle through 3 initial
sites:
A 29-bed neurosurgical ICU in our tertiary care referral hospital

A 14-bed mixed medical-surgical ICU in an urban-rural facility
An 18-bed mixed medical-surgical ICU in a rural hospital
Each ICU in the pilot phase shares a common medical record platform
(Cerner Powerchart), general leadership and data reporting structure, and
telemedicine monitoring capability (Phillips VISICU). The multisite pilot
allowed our team to design and initiate the various processes of the bundle
and develop a data-centered platform on which to base this work.
The 3 pilot sites participated in an 18-month program that included the
following:
Development and use of standardized evidenced-based algorithms as
communicated through the SCCM Collaborative Listserv
Adoption of standardized clinical definitions for ICU daily work
Redesign of nursing and respiratory therapy documentation
Interprofessional education with regular site visits, seminars, and
communication
Creation of data infrastructure to capture metrics through a direct
Cerner-based process
Focused team-based communication to accomplish the complex tasks
above
A process was defined in which critical care physician, nursing, pharmacy,

therapy, and administrative services collaborated to define bundle specifics.
Critical care leadership and local institutions agreed that additional
elements of the bundle needed integration, including glucose management,
minimizing hospital-acquired infections through removal of unnecessary
lines, and assessment of volume status (elements G, H, and I respectively).
Each element of the Atrium bundle required specific tasks and diligence, as
noted in Table 1.
Table 1. Elements of the Atrium Bundle
Element Efforts Required for Systems-Based ICU Care

A: Assessment, Initiated use of CPOT for pain assessment across CHS hospitals.20 Optimized
prevention, and provider order sets to reflect use of CPOT.
management of
pain Standardized CPOT into nursing assessments.
Educated nursing staff to reliably measure and document CPOT.
B: Both SATs and Designed and deployed a universally acceptable SAT/SBT algorithm with Critical
SBTs Care Quality Safety Operations Council and respiratory therapy stakeholders.19,21
Conducted daily safety screen and evaluation for potential extubation in all
mechanically ventilated patients, which included daily interruption of sedation and
analgesia.
Aligned nursing and respiratory therapy policies for mechanically ventilated
patients.
Provided education for all respiratory therapists and critical care nurses.
C: Choice of Ensured widespread adoption of single scale: the Richmond Agitation-Sedation

analgesia and Scale for sedation assessment and clinical documentation.22
sedation
Pharmacy leadership adjusted critical care order sets to require specific clinical
indications for benzodiazepine infusions to limit broad use.
Critical care CPOE sets were adjusted to reflect increasing attention to analgesia
and short-acting sedation strategies.
D: Delirium Adopted and standardized the Intensive Care Delirium Screening Checklist
assessment, assessment and clinical documentation.23
prevention, and
management Developed delirium intervention and prevention strategy by the following:
Improved circadian rhythm alignment by minimizing nocturnal disruptions
including laboratory tests and bathing.
Increased involvement of physical therapy and occupational therapy
leaders in daily care with patient-customized approach toward interventions.
Collaborated with patient experience department to adopt a series of
nonpharmacological interventions, including the Quiet Kit, with resources
and education for the patient and family regarding delirium prevention,
including eye masks and ear plugs.
E: Early mobility Adopted a nursing-based strategic approach toward early mobility definitions and
and exercise interventions from the SCCM Collaborative listserv.24
Worked with physical therapy and occupational therapy specialists to define
specific interventions for appropriate patients.
F: Family Created family engagement guidelines to foster family visitation and integration of
engagement and family in the ICU.
empowerment
Collaborated with patient experience department to develop educational material
for families regarding the campaign and how to best involve families in the daily
plan of care.
Assessed communication between family and the medical team daily.
G: Glucose Noted attention to hyperglycemia in the daily rounding process.25

management
H: Hospital- Reviewed checklist daily to ensure that catheters (central venous, arterial, and
acquired urinary) were removed if not clinically indicated.26
I: “Ins and outs” Paid attention to daily volume status to minimize fluid overload.27
Abbreviations: CPOE, computerized provider order entry; CPOT, Critical-Care Pain Observation
Tool; SAT, spontaneous awakening trial; SBT, spontaneous breathing trial.
Along with algorithm development and deployment, an interdisciplinary

rounding tool was developed for daily rounds and goal setting. The daily
interprofessional collaboration with family engagement on rounds provides
a foundation for improved communication, transparency, and sustainability
of the bundle elements.
Data collection was through Atrium Health’s electronic data warehouse
consisting of Premiere data for length of stay (LOS) and duration of
mechanical ventilation. Unique patient encounters were defined as any
patient admitted to the ICU during this time and each time a single patient
may have readmitted to any of the studied ICUs or transferred across
studied ICUs; therefore, each admission consisted of a unique encounter.
The preintervention time was defined as the first 6 months (December 1,
2015, through May 31, 2016); the postintervention time point was the next
6 months (June 1, 2016, through November 30, 2016). Outcome measures
of interest included ICU LOS, hospital LOS, duration of mechanical
ventilation days, and hospital mortality rate. Additionally, observed-
expected (O:E) ratios were derived for ICU LOS, hospital LOS, and
hospital mortality.
Compliance logic was defined for each of the above bundle elements
(Table 2).
Table 2. Compliance Logic for Individual Bundle Elements
Bundle Measure Definition Denominator Compliance Assessment

Element
A Assessment of Percentage of ICU All ICU patient stays for If pain is assessed at least
pain for ICU patient stays with the entire ICU
every 5 hours during patient’s
patients pain assessed stay duration ICU stay, then compliance =
every 4 hours Yes; otherwise, compliance =
during the ICU stay No.
B SAT screening Percentage of ICU All ICU stays on days in If documentation is present
assessment stays in which the which the patient is before 10 AM for “Interruption
made SAT screening is mechanically ventilated; Performed—Yes” or
completed before ICU day 1 is not “Interruption Performed—No”
10 AM each day included; last day in the on every day that the patient is
that the patient is ICU is not included if mechanically ventilated for an
mechanically patient is discharged ICU stay, then compliance =
ventilated from the ICU before 10 Yes; otherwise, compliance =
AM No.
SAT performed Percentage of ICU All ICU stays on days in If documentation is present
stays in which the which the patient is before 10 AM for “Time
SAT is performed mechanically ventilated Interruption Began” on every
before 10 AM each and the SAT screening day that “Interruption Performed
day that the patient assessment is —Yes” when the patient is
is mechanically completed; ICU day 1 is documented as receiving
ventilated and not included; last day in mechanical ventilation, then
“Interruption the ICU is not included if compliance = Yes; otherwise,
Performed” is patient is discharged compliance = No.
checked “Yes” from the ICU before 10
AM
SBT screening Percentage of ICU All ICU stays on days in If documentation is present
assessment stays in which the which the patient is before 2 PM for “SBT
made SBT screening mechanically ventilated; Performed—Yes” or “SBT
assessment is ICU day 1 is not Performed—No” on every day
performed before 2 included; last day in the that the patient is mechanically
PM each day that ICU is not included if ventilated for an ICU stay, then
the patient is patient is discharged compliance = Yes; otherwise,
mechanically from the ICU before 2 compliance = No.
ventilated PM
SBT performed Percentage of ICU All ICU stays on days in If documentation is present
stays in which the which the patient is before 2 PM and “SBT
SBT is performed mechanically ventilated Performed—Yes,” check that
before 2 PM each and the SBT screening “SBT Start” is documented
day the patient is is passed; ICU day 1 is before 2 PM when the patient is
mechanically not included; last day in documented as receiving
ventilated and the the ICU is not included if mechanical ventilation for an
SBT screening is patient is discharged ICU stay, then compliance =
passed from the ICU before 2 Yes; otherwise, compliance =
PM No.
C Pain and Percentage of ICU All ICU stays in which If the power plan “Adult Critical
agitation stays in which the the patient is for some Pain and Agitation
management or patient is ventilated portion of the stay Management of the
benzodiazepine at some time and mechanically ventilated Mechanically Ventilated Patient”
infusion power the pain and or “Adult Critical
plan used agitation Benzodiazepine Continuous
management or the Infusion Orders” is initiated
benzodiazepine during the ICU stay for a
infusion power plan mechanically ventilated patient,
is initiated during then compliance = Yes;
the ICU stay otherwise, compliance = No.
Assessment of Percentage of ICU All ICU stays in which for If RASS level is assessed and
RASS level for stays in which some portion of the ICU documented at least every 3
mechanically RASS level is stay the patient is hours while the patient is
ventilated assessed and mechanically ventilated mechanically ventilated, then
patients recorded at least compliance = Yes; otherwise,
every 3 hours while compliance = No.
the patient is
mechanically
ventilated
Assessment of Percentage of ICU All ICU stays for

If delirium is assessed at least
delirium stays in which the duration of
every 13 hours during a
delirium is the ICU stay patient’s ICU stay, then
assessed and compliance = Yes; otherwise,
recorded at least compliance = No.
every 12 hours
D
Percentage of Percentage of ICU All ICU stays for
Not applicable
patients stays with at least 1 the duration of
experiencing score >4 during the the ICU stay

delirium during duration of the
ICU stay ICU stay
Safety screen Percentage of ICU All ICU stays for the If “Safety Screen Passed—Yes”
passed stays in which duration of the ICU stay; or “Safety Screen Passed—No”
mobility safety ICU day 1
before noon each day of the
screen is assessed is excluded ICU stay, then compliance =
at least once each Yes; otherwise, compliance =
day before noon No.
E Progressive Percentage of ICU All ICU stays for the If progressive mobility step is
mobility step stays in which duration of the ICU stay documented before noon each
progressive mobility on ICU days when safety day of the ICU stay that the
step is documented screen is passed; ICU safety screen is passed, then
when safety screen day 1 is excluded compliance = Yes; otherwise,
is passed at least compliance = No.
once each day
before noon
F Family meeting Percentage of ICU All ICU stays If family meeting is documented
held stays in which a within 72 hours of ICU
family meeting admission and every 72 hours
occurs and is thereafter, then compliance =
documented within Yes; otherwise, compliance =
72 hours of ICU No.
admission and
every 72 hours
thereafter
Family Percentage of ICU All ICU stays If “family informed,” “other
informed stays in which informed,” “agency informed,”
family, decision or “decision maker informed” is
maker, or other documented within 24 hours of
agency is informed ICU admission and every
within 24 hours of calendar day thereafter, then
ICU admission and compliance = Yes; otherwise,
every day compliance = No.
thereafter
Abbreviation: RASS, Richmond Agitation-Sedation Scale.
RESULTS
We analyzed 5,252 unique patient encounters from December 1, 2015,
through November 30, 2016. Of these, 2,705 were preintervention (during
the first 6 months) and 2,547 were postintervention (from the last 6
months). Although no statistically significant difference was found in age
and sex in the 2 cohorts, the preintervention cohort demonstrated slightly
higher scores on the Acute Physiology and Chronic Health Evaluation
(APACHE Iva) (P = 0.01) and Acute Physiology Score (APS) (P = 0.04).
No statistically significant difference was found in ICU LOS (P = 0.18),
duration of mechanical ventilation days (P = 0.11), or hospital mortality (P
= 0.45). A statistically significant difference was found in actual hospital
LOS (P = 0.03) but the O:E ratio was not statistically significant (P = 0.06)
(Table 3).
Table 3. Study Patient Outcomes
Overall (Before Preintervention Postintervention (June 1, P

and After (December 1, 2016, to November 30, Value
Intervention) 2015, to
2016) (Pre
May 31, 2016) vs
Post)
Total unique encounters, n 5,252 2,705 2,547 NA
Actual ICU LOS, d, median 1.4 [0.7, 2.7] 1.4 [0.8, 2.7] 1.4 [0.7, 2.6] 0.18
[IQR]
Age, y, average (SD) 59.7 (17.2) 60.0 (17.0) 59.3 (17.3) 0.13
Sex, % female 48.9 48.1 49.7 0.26
APACHE IVa score, 53.6 (26.8) 54.5 (26.7) 52.7 (26.9) 0.01
average (SD)
APS score, average (SD) 43.3 (24.7) 44.0 (24.6) 42.5 (24.9) 0.04
ICU LOS O:E 0.63 0.64 0.61 0.21
Actual hospital LOS, d, 4.6 [2.5, 8.6] 4.7 [2.6, 8.7] 4.6 [2.4, 8.4] 0.03
median [IQR]
Hospital LOS O:E 0.71 0.73 0.70 0.06
Actual duration of 1.6 [0.7, 4.3] 1.7 [0.7, 4.5] 1.5 [0.7, 4.1] 0.11
mechanical ventilation, d,
median [IQR]
Hospital mortality rate, % 8.6 8.9 8.3 0.45
Hospital mortality O:E 0.63 0.62 0.65 0.69
Abbreviations: APACHE, Acute Physiology and Chronic Health Evaluation; APS, Acute Physiology
Score; IQR, interquartile range; LOS, length of stay; NA, not applicable; O:E, observed-expected
ratio.
DISCUSSION
The initial pilot phase of implementation of the ICU Liberation Bundle in 2
separate mixed medical-surgical ICUs and 1 subspecialty ICU provided the
basis for understanding initial needs for systemwide adaptation and
adoption of the bundle. Efforts were made to standardize clinical practice,
educate clinical staff, set expectations for daily ICU care, and develop
important data definitions as the work progressed. Algorithms and protocols
from the SCCM Collaborative and from other collaborative sites were used
extensively. This helped our leadership team save time and effort because
materials that had been tested and refined at other institutions could be
simply adapted rather than created de novo. Moreover, by electing to use
standardized scales for pain, agitation, and delirium that were endorsed by
SCCM, we were better able to globally adopt our clinical standards.
Additional barriers to efforts for team process improvement involved the
way the compliance data were disseminated. The original method was to
view all individual assessments for a particular bundle component as one
total event for scoring purposes. That led to an “all-or-nothing” compliance
reporting. This method was used because we were limited by how the data
components were abstracted from the EMR. Updated analytic capabilities
have allowed us to now abstract the discrete components and report them as
individual opportunities instead of a collective whole. This new design will
be implemented soon, and we are excited to see whether these efforts assist
the team in identifying where the true opportunities are and make
improvements based on specific identified areas of opportunity, such as
particular shifts, teams, or individuals. This reporting method also helps to
motivate team members and leaders to celebrate the individual successes of
a clinician’s work.
We have not yet demonstrated significant reductions in length of stay,
duration of mechanical ventilation, and hospital mortality; still, we were
encouraged by the paradigm shift in systems-based care to define, adopt,
and measure standards across a range of facilities and clinical teams. We
believe further efforts are needed in education, refinement of the initiatives,
and better understanding of which elements and efforts provide the greatest
value in ICU performance. We believe that with persistent efforts and
expansion of the bundle, we will see improvement in important hospital
metrics with longer time and increased sample size. Still, we did note
tremendous variances in personnel composition, dialogue, and efficiencies
in daily ICU rounds.28 Such variance may hinder the impact of the ICU
Liberation rounding process, and increased attention to the rounding
process itself will require dedicated efforts.
We have since expanded the ICU Liberation rounding process across the
larger hospital system. We are currently merging the workflows with
clinical documentation, expanding our educational platforms, and further
defining data-driven strategies for clinical performance. The new ICU
Liberation 2.0 definitions were therefore based on these lessons, and are
emblematic of the next phase of our ICU Liberation Expansion. These are
highlighted in Table 4 and Figures 3 and 4.
Table 4. ICU Liberation 1.0 vs ICU Liberation 2.0
The newer definitions of ICU Liberation are revised based on the evolving goals and lessons learned
with the early phase of ICU Liberation. These metrics will be assessed across the ICU beds of the
healthcare system.
Figure 3. ICU Liberation 1.0 vs ICU Liberation 2.0

Figure 4. Examples of differences in metric trends
One of the key lessons learned from our early approach to our latter
approach was that we did not realize in our efforts to promote bundle
adherence, we were creating a sense of perceived “failure” by units and
staff. In other words, our metrics were reporting as an “all or none” in
adherence, which in turn hindered buy-in. We believe that daily monitoring
of each metric in the bundle is important, but that units and staff should be
encouraged to continuously improve. We therefore had to redefine the
language and data metrics to better align with the aims of the ICU
Liberation Bundle, better reflect the daily attention to bundle elements, and
be overall perceived better by the staff and managers responsible for the
work. We believe these efforts will provide the foundation for more
extensive efforts in optimizing ICU patient safety and quality.
SUMMARY
We identified that within a large healthcare system, the ICU Liberation
Bundle is feasible across a broad enterprise. Moreover, this process was
used to support and sponsor a system of critical care integration and
education by helpful selection of appropriate scales of pain, agitation, and
delirium while also providing guidance for awakening-breathing trials,
mobilization, and family engagement. By using and adapting the resources
through the SCCM Collaborative, we were more strategic and streamlined
in this complicated process and were thus able to focus on other meaningful
needs for our organization including but not limited to attention to glucose
control, catheters, and volume status. This care program was layered over
shared EMR platforms, protocols, leadership structure, and telemedicine
monitoring capabilities. We are now able to define patient care goals more
concisely and measure efficacy of ICU processes. Thus, we believe that
ICU Liberation Bundle project helped us create a foundation to catalyze a
more strategic approach toward ICU daily care. Further work will explore
the systemwide impact of the ICU Liberation Bundle process across a range
of ICUs, and further define the impact by disease processes, facility
resources, and cultural and organizational factors. (Table 4, Figures 3 and
4).
We would like to thank the leaders of Atrium Health’s Critical Care
Network, as well as the numerous clinicians, staff, and support personnel
from its facilities. We would also like to thank the SCCM ICU Liberation
Campaign leadership and its teams for facilitation of the collaborative and
this work.
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4. Devlin JW, Skrobik Y, Gélinas C, et al. Executive summary: clinical
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ICU Liberation in the Pediatric ICU: Bringing the ICU
Liberation Bundle to the Bedside of the Critically Ill
Child
Hector R. Valdivia, ARNP, Brent A. Hall, PharmD,
Alix Fitzgerald, CCLS, and John C. Lin, MD
Objectives
Recognize that the normal range of neurocognitive

development seen in children requires pediatric-specific
assessment tools for pain, agitation, and delirium in the PICU.
Understand the unique and important role of the child life
specialist as part of the PICU interprofessional team in
maximizing nonpharmacological interventions to help achieve
sedation and analgesia goals while decreasing exposure to
deliriogenic medications.
Key words: ICU Liberation, sedation, analgesia, delirium, early

mobilization
In 2013, the Society of Critical Care Medicine (SCCM) published clinical

practice guidelines for the management of pain, agitation, and delirium in
adult ICU patients (PAD guidelines).1 Since this initial publication, multiple
adult studies have demonstrated the benefit of individual components as
well as the efficacy of combined implementation of the ABCDEF care
bundle elements, now called the ICU Liberation Bundle.2-6 To more
effectively promote adoption of these initiatives across adult ICUs, SCCM
started a dissemination and implementation program, the ICU Liberation
Campaign, in August 2015. The ICU Liberation Collaborative began as a
nationwide effort to promote ongoing uptake of the ICU Liberation Bundle,
to foster interprofessional collaborative teamwork and practice, and to study
the impact of large-scale application of this comprehensive approach to care
across varied ICU and hospital settings throughout the United States. In a
consistent dose-response fashion, higher ICU Liberation Bundle
compliance correlated with progressive improvements in clinically
meaningful patient outcomes including survival, duration of mechanical
ventilation, delirium and coma incidence, ICU readmission rate, and post-
ICU discharge disposition.7
Application of individual ICU Liberation Bundle elements in pediatric ICU
patients (PICU Liberation) has also demonstrated benefit.8-11 PICU
Liberation follows the same strategic approach of emphasizing
interprofessional team collaboration; creating unit-wide consistency in
identifying, preventing, and treating pain, anxiety, and delirium; daily
assessments of extubation readiness; and early rehabilitation initiation and
continued progression throughout the PICU stay. However, the perceived
barriers to ICU Liberation Bundle implementation in children among
pediatric ICU professionals, the broad range of normal and atypical
developmental and neurocognitive stages, and the role of parents and family
members as primary medical decision makers all require a different tactical
approach to managing sedation in the critically ill child12 and addressing
the overall behavior and culture observed in the PICU.13 This chapter
outlines pediatric-specific tools, pediatric pharmacological considerations,
and the role of the child life specialist as part of the PICU interprofessional
team in optimizing nonpharmacological interventions to achieve sedation
and analgesia goals and minimize exposure to deliriogenic medications.
PEDIATRIC BEDSIDE ASSESSMENT TOOLS
Pain Assessment
Objectively assessing pain in pediatric patients requires scales that consider
the cognitive, emotional, and developmental capabilities of children and
their changes with growth over the entire pediatric age range, where age is
often only an approximation of this capacity, particularly in patients with
cognitive impairments from their underlying medical condition.14 Pain
assessment tools are based on 2 general categories: self-report by the patient
or observation of the patient. Given the inherent subjective nature of pain,
self-report measures have been accepted as the gold standard method.1,15
For older patients, the visual analog scale (VAS) requires patients to mark a
point along a nonlabeled continuum of pain that allows for better
discernment of relative degrees of pain.16 However, the VAS requires a
higher degree of abstraction on the part of patients in describing their pain,
requires use of a physical tool, and is not amenable to telephone follow-up
rating. In comparison, numeric rating scales (NRS) have been widely used
in the inpatient setting and can be administered without any supporting
materials. Patients are simply asked to rate their pain on an 11-point scale
from 0 to 10 (NRS-11).17 The NRS-11 has been validated and well-
established for use in children older than 8 years; additional advantages of
the NRS-11 over the VAS include ease of use, reproducible cutoff values of
4 and 8 to distinguish moderate and severe pain, and easy compatibility
with electronic medical system documentation.18 The addition of
representative facial expressions correlating with numeric pain ratings
allows use in patients as young as 3 years, who may have difficulty
abstracting their perceived pain into a discrete numeric value. These facial
expression–based scales include the Oucher pain scale,19 the Faces Pain
Scale–Revised (FPS-R),20 and the Wong-Baker Faces Pain Rating Scale
(WBFPRS).21 Of these, none has been demonstrated to be superior to
another for clinical use in soliciting self-reports of pain. However, the
WBFPRS uses a smiling face to represent absence of pain rather than the
neutral face used in the FPS-R, a factor that could lead to confounding
anxiety and fear with pain. For research use, the FPS-R has been
recommended based on its ease of use and its favorable psychometric
features.22
In contrast to self-reported pain scales, observational assessment tools rate a
patient’s degree of pain based on observable behaviors. This allows pain
assessments in preverbal infants and toddlers as well as children who are
nonverbal because of their atypical developmental state or because of their
illness and need for interventions such as invasive mechanical ventilation.
Although not validated for use in this fashion, the NRS, VAS, and FPS have
all been used as global rating scales for the observer’s overall impression of
a patient’s pain. Significant drawbacks include not having specific
anchoring behaviors for each assigned pain level and having a significant
risk of observer bias.23 In comparison, the Faces, Legs, Activity, Cry, and
Consolability (FLACC) tool meets these criteria. Developed first for
nonverbal children ages 2 months to 7 years undergoing surgical
procedures, the FLACC tool assigns values of 0 to 2 in each of the
eponymously named 5 domains supported with specific anchoring
descriptions for each score in each domain.24 In a small group of patients
experiencing postoperative pain, the FLACC score correlated well with FPS
self-reported by children ages 5 to 7 years, supporting FLACC validity.25
The revised version (r-FLACC) was updated to allow use in cognitively
impaired children by incorporating comparison of behavior and muscle tone
to parental reports of baseline state. Although developed specifically to
account for individualized behaviors seen in neurodevelopmentally atypical
children, the r-FLACC can be used in developmentally appropriate children
as well.26-28
Sedation, Agitation, and Distress Assessment

Pain may not be the sole reason for distress or agitation. Thus, assessment
tools based on behavioral manifestations of distress must be used to
supplement pain-specific scores, particularly in the nonverbal patient. All of
these tools assign scores to behaviors along a spectrum of activity from
none to excessive. Here again, the VAS and NRS have been used with the
extreme ends of the scale representing “absolutely calm” and “extremely
distressed,” requiring the observer to mark a point on the nonnumeric line
or assign a numeric value to the degree of perceived distress.29,30 Similar
issues with the use of these scales for pain rating based on observer-
assigned values exist when used for agitation assessment. Thus, attempts to
create more standardized assessments led to development of the
COMFORT scale. Originally designed and validated specifically for PICU
patients, COMFORT assigns ratings of 1 through 5 across 8 different
dimensions that included behaviors, expressions, and vital signs, to give a
total score range of 8 to 40.29 Notably, of the 8 dimensions, the 2
dimensions assigned as heart rate and mean arterial pressure correlated best
with each other and worst with the other 6 behavioral and psychological
dimensions.29,31 The poor sensitivity and specificity of vital signs with
agitation led to modification of this scale to the COMFORT “behavior”
scale by eliminating heart rate and mean arterial pressure, leaving only 6
dimensions to give a total score of 6 to 30.31,32 In comparison, the State
Behavioral Scale (SBS) provides a simpler score ranging from −3
(unresponsive) to <+2 (agitated). Each value has specific anchoring
descriptors to promote interrater reliability and increase specificity for
sedation rather than both pain and sedation.30 The SBS has been used
successfully in the largest trial of pediatric sedation management in
intubated patients.33 More recently, the Richmond Agitation-Sedation Scale
(RASS), originally developed and validated for adult ICU patients, has been
validated in the PICU population from 2 months to 21 years of age.34-36
Because the RASS ranges from −5 to <+4, it potentially provides greater
discernment of varying levels of awareness when compared with SBS
(Table 1).
Table 1. Richmond Agitation-Sedation and State Behavioral Scale
Richmond Agitation-Sedation Scale (RASS)34- State Behavioral Scale (SBS)30

36
4: Combative +2: Agitated

Overly combative or violent; poses May have difficulty breathing with ventilator
immediate danger to self Coughs spontaneously
No external stimulus required to elicit response
Spontaneously pays attention to care provider
3: Very agitated Unsafe (biting endotracheal tube, pulling at
Pulls on or removes tube(s) or catheter(s) catheters, cannot be left alone)
or has aggressive behavior toward staff Unable to be consoled
Increased movement (restless, squirming, or
thrashing side-to-side, kicking legs)
2: Agitated
Frequent nonpurposeful movement or
patient-ventilator dyssynchrony
1: Restless +1: Restless and difficult to calm

Anxious or apprehensive but movement Spontaneous effective breathing; has difficulty
not aggressive or vigorous breathing with ventilator
Occasional spontaneous cough
Responds to voice; no external stimulus is required
to elicit response
Drifts off; spontaneously pays attention to care
provider
Intermittently unsafe
Does not consistently calm despite 5-min attempt;
unable to be consoled
Increased movement (restless, squirming)
0: Alert and calm 0: Awake and able to calm

Spontaneous and effective breathing
Coughs when repositioned or occasional
spontaneous cough
Responds to voice; no external stimulus is required
to elicit response
Spontaneously pays attention to care provider
Becomes distressed with procedures
Able to be calmed with comforting touch or voice
when stimulus removed
Occasional movement of limbs or shifting of
position or increased movement (restless,
squirming)
1: Drowsy −1: Responsive to gentle touch or voice

Not fully alert but has sustained ( >10 s) Spontaneous but ineffective nonsupported breaths
awakening, with eye contact, to voice Coughs with suctioning or repositioning
Responds to touch or voice
Able to pay attention but drifts off after stimulation
Becomes distressed with procedures
Able to be calmed with comforting touch or voice
when stimulus removed
Occasional movement of limbs or shifting of
position
−2: Light sedation −2: Responsive to noxious stimuli

Briefly (<10 s) awakens with eye contact Spontaneous yet supported breathing
to voice Coughs with suctioning or repositioning
Responds to noxious stimuli
Unable to pay attention to care provider
Will become distressed with a noxious procedure
Does not move, or occasional movement of limbs
or shifting of position
−3: Moderate sedation −3: Unresponsive

Any movement (but no eye contact) to No spontaneous respiratory effort
voice No cough, or coughs only with suctioning
No response to noxious stimuli
Unable to pay attention to care provider
−4: Deep sedation Does not become distressed with any procedure
No response to voice, but any movement (including noxious)
to physical stimulation Does not move
−5: Unarousable
No response to voice or physical
stimulation
RASS and SBS scores modified and reprinted from two separate sources with permission. RASS:
Reprinted with permission of the American Thoracic Society. Copyright © 2020 American Thoracic
Society. Modified from Sessler CN, Gosnell MS, Grap MJ, et al. 2002. The Richmond Agitation-
Sedation Scale Validity and Reliability in Adult Intensive Care Unit Patients. Am J Respir Crit Care
Med. 166:1338-44. The American Journal of Respiratory and Critical Care Medicine is an official
journal of the American Thoracic Society. SBS: Reproduced with permission Curley MA, Harris SK,
Fraser KA, et al. State Behavioral (SBS): A Sedation Assessment Instrument for Infants and Young
Children Supported on Mechanical Ventilation. Pediatr Crit Care Med. 2006; 7:107-114. Copyright
© 2006 the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and
Critical Care Societies. All rights reserved.
Delirium Assessment
Recognition of delirium in the PICU population has markedly increased in
the past 10 years. The advent of 3 pediatric delirium assessment tools has
aided in our understanding of the incidence of delirium and correlation with
worse neurological outcomes in critically ill children. The Pediatric and
Pre-school Confusion Assessment Method–ICU (pCAM-ICU and psCAM-
ICU) were developed and based on the similarly named adult CAM-ICU
screening tool.37,38 Validated in children as young as 5 years of age
(pCAM-ICU) and from 6 months to 5 years (ps-CAM-ICU), these
screening tools allow ICU practitioners to assess for in-the-moment
presence or absence of delirium in an interactive and cognitively oriented
fashion. Importantly, these two tools have not been validated for use in
children with developmental delay.
In comparison, the Cornell Assessment for Pediatric Delirium (CAPD)
provides an observation over time of behaviors encompassing both
hypoactive and hyperactive delirium regardless of age or cognitive
capacity.39,40 Administered by the bedside nurse based on multiple patient
interactions over an entire shift, the CAPD does not require patient
participation and is entirely observational, allowing use even in
developmentally delayed patients. By anchoring assessments to typical age-
based developmental milestones, the CAPD assigns scores on a 0 to 4
Likert scale across 8 dimensions for a total range of 0 to 32, with scores 9
or higher indicating a high risk of delirium. The single largest evaluation of
pediatric delirium prevalence in the PICU used the CAPD as its delirium
screening tool.41
More recently, the Sophia Observation Withdrawal Symptoms Scale–
Pediatric Delirium tool (SOS-PD) was validated for screening of delirium
and withdrawal in children between 3 months and 18 years old who have
been in the PICU for 48 hours or longer or who have received
benzodiazepines and/or opioids for 5 days or more.42-44 The SOS-PD
consists of 3 sections: comparison of current vital signs with established
baseline range; parental assessment of the child’s behavior compared with
the child’s typical behavior (eg, “This is not my child”); and observations of
22 distinct behaviors. Notably, the inclusion of parental input into the SOS-
PD provides an unproven but potential advantage in sensitivity of this tool
compared with either the CAPD or CAM-ICU tools. The 22 behavioral
observations acknowledge that delirium and withdrawal symptoms overlap
and consist of 17 delirium-specific and 5 withdrawal-specific observations;
10 behaviors are considered overlapping and consistent with either delirium
or withdrawal. The 17 delirium observations are performed once in the
latter half of each bedside nursing shift to allow sufficient evaluation of the
child’s behavior over time. The tool prompts referral to psychiatric
evaluation for a threshold delirium score of ≥4 out of the 17 delirium-
specific behavioral observations, parental assessment of abnormal child
behavior, or if the patient appears to be having hallucinations.
All 3 of these delirium screening tools can be performed only in patients
who have sufficient levels of consciousness to respond. For the CAM-ICU
and SOS-PD tools, RASS scores of −4 or −5, correlating with a deeply
sedated or unarousable state, preclude administration of the tool. For
CAPD, a RASS score of −4 or −5 or an SBS score of −2 or −3, correlating
with unresponsive or only responsive to noxious stimuli, preclude use.
Assessment of Iatrogenic Withdrawal Symptoms

The SOS-PD has also been validated for screening of iatrogenic withdrawal
syndrome (IWS).42,45 Designed for use when patients have received
benzodiazepines and/or opioids for 5 days or more, the SOS-PD entails
comparison of current with established baseline vital signs, and the 15
withdrawal behavior observations are assessed at least once a shift after
medication weaning begins, with 1 point assigned for every observed
behavior. Additional observations are performed within 2 hours of receiving
therapies to treat IWS. An SOS-PD withdrawal score of 4 or higher
provides the best specificity for IWS, whereas a score of 3 or higher
provides the best sensitivity.
The Withdrawal Assessment Tool-1 (WAT-1) has been validated as a
screening tool to be used at the start of benzodiazepine and/or opioid
weaning after exposure for 5 or more days. The WAT-1 incorporates 11
observed behaviors with a maximum score of 12.46,47 In contrast to the
SOS-PD, the WAT-1 assesses behaviors over different time periods and
includes an assessment of ability to calm after a stimulus. WAT-1
developers recommend use at least every 12 hours in combination with SBS
assessment, with more frequent scoring as needed if IWS is identified and
to assess response to therapy. A score of 3 or higher provides the best
combination of sensitivity and specificity for IWS.
PEDIATRIC PHARMACOLOGICAL CONSIDERATIONS

Differences in body composition, physiological characteristics, and
pharmacokinetic parameters complicate the pharmacological approach to
analgesia and sedation in the PICU, where the patient population ranges in
age from neonate through adolescent.48 This variability in physical and
neurocognitive development has resulted in a relative lack of literature
either assessing comparative effectiveness of different pharmacological
approaches or providing guidelines for clinical practice when addressing
pain and sedation management in the critically ill child.49 Accordingly,
there is limited agreement among pediatric critical care practitioners about
the best regimen of analgesia and sedation medications to optimize pain
relief and to achieve sedation goals in the pediatric critical care population
even after considering underlying disease state and cardiopulmonary
status.50-53
Despite the lack of definitive evidence demonstrating superiority of any one
pharmacological regimen, multiple studies have demonstrated the benefit of
using a nurse-driven, goal-directed approach to sedation and analgesia
management. Reported benefits include reduction in duration of mechanical
ventilation,54-56 decreased cumulative drug exposure,33,54,56 decreased
incidence of delirium,10 and reduced incidence of iatrogenic withdrawal
symptoms.57 Notably, however, the largest trial of pediatric sedation and
analgesia management in intubated pediatric patients in North America
(Randomized Evaluation of Sedation Titration for Respiratory Failure
[RESTORE]) using a nurse-driven, goal-directed sedation approach failed
to demonstrate a difference in duration of mechanical ventilation but did
definitively demonstrate the feasibility of large-scale implementation of
nurse-driven sedation and analgesia management.33 As a result, just as
recommended in adult ICU patients, incorporation of routine pain and
sedation assessments, goal-setting for pain and sedation levels, and nurse-
driven titration is becoming accepted best-practice in the PICU. The rest of
this section reviews the pharmacological data surrounding
dexmedetomidine, fentanyl, morphine, and midazolam. These 4 agents have
been most commonly reported as starting regimens for sedation and
analgesia in the PICU.50
Dexmedetomidine
Dexmedetomidine, a selective α2 agonist with sedative properties, works on
receptors in the locus coeruleus to mimic natural sleep while stimulating α2
receptors in the brain, spinal cord, and peripheral sites to cause mild
analgesia. Benefits of dexmedetomidine include improved efficacy in
patients with neurological impairments, potential for decreasing opioid
and/or benzodiazepine requirements, and less effect on respiratory drive.
These properties make dexmedetomidine an attractive sedative during
procedural sedation and noninvasive ventilation. Observed clinical benefits
include decreased duration of mechanical ventilation,58 shortened ICU
length of stay,59 and decreased incidence and/or duration of delirium.60,61
Limitations of the use of dexmedetomidine include reduced efficacy in
patients with higher ICU acuity,62,63 hemodynamic effects including
bradycardia and hypotension,64 and lack of amnestic properties.
Consequently, use of dexmedetomidine alone for sedation would seem
inappropriate in patients receiving neuromuscular blockade. Nevertheless,
dexmedetomidine use for PICU sedation has been increasing steadily. The
RESTORE trial used midazolam and morphine infusions as the
protocolized pharmacological approach in the intervention groups but
observed a progressive increase in dexmedetomidine use for sedation
during invasive mechanical ventilation in the control PICUs where sedation
and analgesia selection was not protocolized. In these control PICUs,
dexmedetomidine nearly doubled from 38% in 2009 at the start of the trial
to 61% by 2013 when the trial concluded.33 This observed practice change
reflects an increasing penetration of dexmedetomidine into sedation
practice, even though the only available literature focuses on safety profiles
and broadening indications for use.65 Withdrawal symptoms have been
noted in patients receiving continuous infusion for more than 72 hours.66
In adults, dexmedetomidine follows linear kinetics and is primarily
metabolized via N-glucuronidation and to a lesser extent by CYP 2A6 and
N-methylation. Pediatric patients have differing pharmacokinetics and
observed half-life (T½) due to differences in volume of distribution (Vd)
from higher fat distribution and lower protein and albumin levels as well as
clearance rates due to immature hepatic elimination pathways. Premature
infants appear to have the highest Vd and lowest clearance resulting in the
longest T½: 7.6 versus 3.2 versus 2-2.5 hours in premature versus term
infants versus adults, respectively. Blood-brain barrier immaturity further
complicates dosing, with observed higher cerebrospinal fluid concentrations
in neonates. Animal data also suggest a higher density of α2 receptors in the
postnatal period. Current data support serum concentrations of 0.4 to 0.8
μg/L to be sufficient for general sedation; these levels appear to be achieved
with maintenance doses of 0.33 μg/kg/h in term neonates and 0.53 μg/kg/h
by age 2 years.67-70
Midazolam
Midazolam, a short-acting benzodiazepine with rapid onset, stimulates γ-
aminobutyric acid (GABA) receptors in the central nervous system to
generate anxiolysis, amnesia, sedation, hypnosis, and muscle relaxation.
Use for sedation in adults and children has a long history, and midazolam is
the best studied drug of all sedative agents used in the PICU.49 Benefits
include its amnestic properties and anticonvulsant effects as well as the
ability to achieve deep sedation. Limitations to its use include hypotension,
cardiac depression, potential for withdrawal, and development of tolerance.
Further concerns surrounding midazolam have been identified in more
recent literature, including associations with increased duration of
mechanical ventilation and increased length of stay.71 As well, recognition
of the association of benzodiazepine use and higher rates of delirium has
increased.60,71-73 These latter correlations with undesired, meaningful
clinical outcomes have resulted in recommendations to limit
benzodiazepine exposure in adults when possible, with similar
recommendations beginning to appear in the pediatric literature.1,74
Midazolam is a highly lipophilic and protein-bound benzodiazepine
requiring both hepatic and renal clearance; midazolam undergoes hepatic
metabolism via CYP3A4 to 3 metabolites with subsequent renal excretion,
one of which is active.75 Midazolam pharmacokinetics in children
compared with adults demonstrate similar Vd but decreased clearance and
thus longer T½, with lower clearance observed in premature infants and
neonates compared with older children and adolescents.76 Further
complicating midazolam pharmacokinetics, midazolam clearance
demonstrates large individual variation from patient to patient and is
prolonged during critical illness with both noninflammatory and
inflammatory states.77,78 Consequently, although the typical recommended
starting dose for continuous infusion ranges from 0.05 to 0.1 mg/kg/h in
children, and is less than 0.05 mg/kg/h in premature infants, serial
assessments of sedation level are crucial for achieving sedation goals.
Morphine
Morphine is a naturally occurring alkaloid that is considered the
prototypical opioid analgesic against which other analgesic medications are
compared. Its analgesic effects result from stimulation of the μ-, δ-, and κ-
opioid receptors. μ-Receptor stimulation in the central and peripheral
nervous systems causes the majority of morphine’s analgesic properties by
increasing central inhibitory nociceptive pathways and inhibiting peripheral
nociceptive afferent neurons. With its longer duration of action and
moderate sedative properties, morphine provides more stable dosing and the
dual effect of analgesia and sedation. This sedative effect has important
clinical impact and likely contributes to the observed lower use of
benzodiazepines in patients receiving morphine rather than fentanyl for
analgesia in mechanically ventilated PICU patients.52 Side effects include
respiratory depression, constipation, nausea, euphoria, hemodynamic
instability, and induced histamine release causing pruritus and possible
bronchospasm.51
Morphine undergoes hepatic metabolism via glucuronidation into 2 active
metabolites, morphine-3-glucoronide and morphine-6-glucoronide, which
are renally excreted and thus accumulate with renal dysfunction. Morphine
pharmacokinetics appear to be similar between children older than 1 year
and adults. In comparison, preterm neonates show a higher renal clearance
of unchanged drug, and neonates and infants demonstrate differences in
protein binding resulting in higher levels of free drug available for
pharmacodynamic effect. However, infants appear to require a 7-fold higher
morphine plasma concentration for control of pain than older children yet
have a higher risk of respiratory depression. Immaturity of opioid receptors
causing decreased analgesic effects but increased respiratory depression and
decreased active metabolite production from immature sulfation metabolic
pathways likely contribute to the need for higher plasma concentrations.
This variability in the pharmacokinetics seen in the youngest PICU patients
and the buildup of active metabolites with renal dysfunction highlight the
importance of close monitoring to achieve adequate analgesia while
minimizing respiratory depression.76,79,80
Fentanyl
Fentanyl is a synthetic opioid 50 to 100 times more potent than morphine
with rapid onset and short duration that has minimal hemodynamic
effects.81 Its analgesic effects result primarily from stimulation of the μ-
opioid receptor as well as its less potent activity on the δ- and κ-receptors.
Side effects notably include respiratory depression, constipation, nausea,
and euphoria. At higher doses, these central effects include sedation,
delirium, and dyskinesia. In addition, long-term use leads to significant
tolerance and high risk of IWS with exposure to a cumulative dose greater
than 1.6 mg/kg or infusion for more than 5 to 9 days.76,82 Thus, although
fentanyl may have additive effects to other sedative medications such as
benzodiazepines and α2 agonists that augment sedation, the rapid
development of tolerance and high risk of withdrawal make fentanyl a poor
choice for primary sedation purposes.
Fentanyl undergoes hepatic metabolism via N-dealkylation and
hydroxylation, with 6% renally excreted as unchanged drug. Due to
increased hepatic blood flow in children age 6 months to 6 years, fentanyl
clearance is faster than in adults. In contrast, neonates demonstrate a slower
clearance similar to adults, potentially due to delayed meconium excretion
and higher bilirubin concentrates. Prematurity does not appear to affect
clearance, but it has been noted that children less than 34 weeks gestation
appear to require less fentanyl for adequate sedation.76,83,84
PICU INTERPROFESSIONAL TEAM AND THE ROLE OF

THE CHILD LIFE SPECIALIST
Developing effective interprofessional collaboration requires intentional
effort and understanding of individual roles and appreciation for the
expertise and contribution of each team member. A broad and in-depth
body of evidence correlates the effectiveness of team-based unit structure
with patient outcomes, with a resulting summary statement highlighting this
approach as the best practice model for both adult and pediatric ICUs.86
Recently, Donovan et al87 described in great detail the roles and
responsibilities of the individual team members comprising the adult ICU
team. This comprehensive review summarizes the literature supporting the
benefit of meaningful patient outcomes when collaborative teamwork
occurs from each profession: critical care nurses, advanced practice
providers, critical care pharmacists, respiratory therapists, rehabilitation
therapists, dieticians, spiritual care providers, social workers, physicians,
and patients and family members. The PICU team incorporates all of these
same professions but also includes a role unique to pediatric care: the
certified child life specialist (CCLS).
Although any one bundle element may require more involvement of one
individual profession to achieve compliance, different professions hold
greater roles for different elements, each of which overlaps, supports, and
amplifies the impact of the other bundle elements. Thus, optimal success
with ICU Liberation Bundle implementation requires effective
communication and coordination of efforts across multiple professions in
order to achieve best results.85 For example, extubation readiness testing
(ERT) in pediatric patients, similar to the spontaneous awakening trials and
spontaneous breathing trials described in intubated adult patients,
incorporates a safety screen to identify patients for whom an ERT can be
performed safely. Bundle compliance metrics would be high if an intubated
patient underwent a safety screen each day that identified lack of respiratory
drive as an excluding parameter for subsequent testing, regardless of
whether the patient demonstrates hypopnea caused only by excessive
sedation. Similarly, unrecognized and unaddressed delirium can result in
profound agitation and accompanying tachypnea and tachycardia, vital sign
changes that could be misconstrued to mean that an ERT either is unsafe to
attempt or is not tolerated. As a result, unidentified delirium could
contribute to unnecessarily prolonged duration of invasive ventilator
support. In these scenarios, despite achieving high ERT compliance metrics
because of completion of the ERT process, ERT performance would be low
due to failure to accomplish the goal of the ERT: early identification of
resolution of the disease process necessitating invasive ventilator support
and subsequent timely extubation. Meeting the ultimate goal of this one
bundle element (ie, B) in these two common examples thus requires
effective completion of bundle elements A, C, and D. The CCLS can play a
significant role in achieving the goals of the A and C bundle elements
without relying only on pharmacological interventions.
Child life programs began in the 1920s as early hospital play programs and
evolved into the first Child Life and Education division in 1955 at
Cleveland City Hospital. This landmark program was founded by Emma
Plank to address the unique needs that children have when faced with
illness. The positive impact of child life programs has been recognized
across the world, and a hospital’s ability to provide child life services is
now recognized as a quality benchmark and marker of excellence.
Requiring a 4-year bachelor’s degree in child life, child development, or
other related field, a CCLS must then complete a 480- to 600-hour
internship and pass a certifying examination. With this background, the
CCLS considers child and family variables and the impact of diagnosis and
treatment variables.
The American Academy of Pediatrics considers the role of the CCLS to use
play and developmentally appropriate communication to achieve 6 goals:
(1) promote optimal development; (2) educate children and families about
health conditions; (3) prepare children and families for medical events or
procedures; (4) plan and rehearse useful coping and pain management
strategies; (5) help children work through feelings about past or impending
experiences; and (6) establish therapeutic relationships with patients,
siblings, and parents to support family involvement in each child’s care.88
Techniques used to achieve the patient goals include use of therapeutic play,
distraction, combined cognitive behavioral therapy, and visual imagery.89
Specific support for family members uses strategies such as coaching,
counseling, empowerment, and education.88,90,91 One can easily see how
the CCLS plays a crucial role in optimizing performance of the F bundle
element. By working with families on how to participate in their child’s
care while in the PICU, the CCLS can share strategies on how to engage in
therapeutic play, empower families to advocate for the child with the
medical team, and provide another medical team resource from whom
families can gain understanding and support.
These child life strategies have also been demonstrated to have significant
impact in other ICU Liberation Bundle elements. When used in addition to
pharmacological therapies, child life techniques provided a
nonpharmacological approach for treatment of pain and anxiety during
emergency department procedures and radiological diagnostic testing to
decrease sedative and analgesic use.92,93 In addition, integration of child life
services into an interprofessional approach to delirium prevention
demonstrated high patient and family satisfaction.94 With the ability to
affect the patient’s and family’s PICU experience in profound ways, the
CCLS serves as a crucial member specific to the PICU interprofessional
team. Indeed, a recently completed Cochrane Review concluded that
integration of child life techniques in clinical practice during pediatric
medical care can reduce pain and distress.89
SUMMARY
Optimizing interprofessional team collaboration serves as the foundation
for successful implementation of ICU Liberation strategies in the PICU to
achieve the primary goal of allowing PICU patients not only to survive their
critical illness but to have the best opportunity to return to their preillness
neurocognitive, physical, and psychosocial developmental trajectory. With
understanding of each team member’s role, unique expertise, and
contributions in caring for the critically ill child, the use of pediatric-
specific tools facilitates achievement of pain and sedation goals, delirium
screening and prevention, and ultimately initiation of early mobilization.
KEY POINTS
Pediatric-specific scoring tools should be used to assess pain, sedation,
and delirium in the PICU patient.
Pharmacokinetic considerations across the pediatric age spectrum must
be considered when selecting and dosing commonly used sedatives
and analgesics in critically ill children.
Inclusion of a certified child life specialist as an integral member of
the PICU interprofessional team can greatly amplify integration of
family members into the PICU team.
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Future Directions for ICU Liberation
Caroline L. Lassen-Greene, PhD, MS, Matthew F. Mart, MD,
James C. Jackson, PsyD, and E. Wesley Ely, MD, MPH
Objectives
Discuss future directions for efforts to liberate individuals from

the ICU and iatrogenic harm.
Challenge providers to cultivate practices to uphold the human
dignity and welfare of ICU patients, families, and caregivers.
Highlight and articulate the role of specialists from wide-
ranging disciplines in the care of ICU survivors.
Key words: post–intensive care syndrome (PICS), ICU survivors,

ICU Liberation Bundle, delirium, mechanical ventilation, sedation,
caregiver burden, survivorship, family engagement
The advances in critical care medicine over the last 50 years reflect a
nascent process of humanizing the care of patients and families during and
after ICU hospitalization. The stark image of the critically ill patient
confined to a hospital bed, complacently dependent on mechanical
ventilation, deeply sedated, isolated from family and friends who wait
anxiously at a distance for a chance to see their loved one once again, has
evolved into a more vibrant collage depicting an empowered person who is
increasingly alert and awake, challenged to breath freely without machines
and move beyond the hospital bed, and comforted by loved ones. This
profound shift has emerged from the tireless efforts to build the ICU
Liberation Bundle to mitigate iatrogenic harm and post-ICU human
suffering.1-3 After initial advances in critical care medicine powered
substantial improvements and innovations in the treatment of illnesses with
high mortality, the need to address the burden of ICU survivorship became
evident, concerning, and of utmost urgency.4
Despite the maturation in ICU care, the risk of iatrogenic harm and long-
term consequences of critical illness continue to jeopardize human dignity,
challenge patient identities, and compromise perceived self-worth.5,6 When
reflecting on the goals of ICU Liberation through which “the patient is to be
liberated from anything that threatens his or her sense of self-worth,
identity, and human dignity,” we recognize that our living framework of
ICU care must welcome novel approaches along the continuum of recovery
from critical illness, expand our interprofessional teams and support
networks, and extend its reach to patients and settings that grapple with
barriers to quality care in a manner that allows for movement and flexibility
to adapt to the needs and values of each patient and treatment setting.7,8
POST–INTENSIVE CARE SYNDROME: A REASON FOR

CHANGE
The determination and efforts sustaining these great improvements in ICU
care stem from the recognition of post–intensive care syndrome (PICS), a
condition that refers to a myriad of new or worsening cognitive, physical,
and psychological impairments experienced by survivors of critical
illness.9-12 As we have listened to our patients’ concerns and experiences
following ICU care, we have identified the far-reaching implications of
PICS and the challenges that ICU survivors face. The cost of survivorship is
high, with individual loss and suffering, personal and societal costs, and
public health and family/caregiver burden.5,13-15 The following statements
from ICU survivors not only illustrate the severity of PICS but also show
the complexity and entanglement of physical, cognitive, psychological, and
functional states following critical illness. These ICU survivors were saved
by medicine, a historically ideologically compartmentalized practice, and
their recovery depends upon the recognition of the holistic nature of patient
health and wellness.
“I would tell my family and doctors that what I was experiencing
was like having Alzheimer’s and knowing it but nothing I said seem
to be of any aid so I figured there wasn’t anything anyone could do.
I became isolated and excluded from everyone; no one wanted to be
around me.”
“My work suffers and I don’t know how much longer I’ll be able to
go on with it (although I haven’t admitted as much to my employer)
and I tire incredibly easily. . . . The past and present pain and
uncertainty of my underlying physical conditions (pancreatitis, renal
failure, etc) are a comparative cakewalk compared to seeing severed
heads in glass jars and being confused all the time. This is simply
unsustainable.”
“I spent eight days in the ICU . . . and I am still tortured by the life-
changing experience that happened to me. I suffer from acute
depression and anxiety, as well as changes in my personality and
behavior. I am on medications and know in my heart that without
them I could not have any chance of a life.”
These commentaries epitomize the burden of ICU survivorship that plagues
our patients. As part of the coordinated response to provide holistic and
synergistic care, the ICU Liberation Bundle was developed and has been
widely implemented with varying success, with improvements in mortality
and recovery from critical illness.8,16-18 The bundle combines refined and
evidence-based care for sedation and analgesia management, weaning
protocols from mechanical ventilation, delirium prevention and treatment,
early mobilization, and family engagement to improve outcomes and reduce
the burden of PICS among ICU survivors.
Yet, ICU patients and survivors continue to struggle with varying degrees of
debilitating physical, cognitive, and psychological impairments that
challenge their autonomy, dignity, and identity.19-24 Directions for future
research and quality improvement efforts aimed to lessen the threat to ICU
patients and survivors are vast and plentiful. Some of these avenues that
deserve greater attention include identifying optimal sedation agents for
patients on mechanical ventilation both with and without delirium,
optimizing implementation in ICUs with varying amounts of resources, and
considering the dose-response relationship of the ICU Liberation Bundle
implementation with clinical outcomes. However, perhaps the most
pressing of these areas is the toll of survivorship on individuals, families,
and caregivers, which is only expected to increase with advances in critical
care medicine coupled with many populations aging at an unprecedented
rate.
No uniform approach is available for the assessment or treatment of
survivors of critical illness. Indeed, current approaches to PICS care tend to
be fragmented, highly variable, and biased toward physical interventions
without adequate consideration of acquired dementia, psychological
adjustment, or posttraumatic stress disorder (PTSD); they might be offered
months to years after an ICU stay, and they can contribute to poor patient
and family recovery. The current care model inadequately addresses the
heavy toll on healthcare services, the persistent needs of this vulnerable
patient and caregiver population, and gaps in continuity of care for ICU
survivors. As such, exploring patient-centered and recovery-oriented
models of care to reduce family and caregiver distress during and after
critical illness is of utmost importance.25
TOWARD A RECOVERY-ORIENTED MODEL OF CARE

Redefining recovery is an integral step in planning and implementing a
successful comprehensive care plan for survivors of critical illness.
Recovery from critical illness encompasses much more than the treatment
of illness in acute settings. Defining ICU survivorship and recovery requires
a broad perspective and awareness of the person, ICU-acquired
impairments, and the intersection of post-ICU health with the patient’s
environment and premorbid life. On a fundamental level, recovery is a
process of discovering and fostering self-empowerment, redefining the self,
returning to basic functioning, and improving quality of life, yet there is no
consensus on what defines recovery from critical illness.26 The concept of
recovery, although untapped and underdeveloped in the care of ICU
survivors, has been deeply explored and fostered among other patient
populations and care settings including mental health treatment and
rehabilitation medicine. For example, recovery-oriented systems of care
provide a framework with many key components relevant to recovery from
critical illness.27 As intensivists and other critical care providers
collaboratively expand best models of care for ICU survivors, it may be
timely to consider the substantial overlap in existing care models used more
frequently in mental health recovery, such as the recovery-oriented systems
of care.
Upon examination of select core concepts of recovery-oriented systems of
care, we notice striking similarities with our current efforts and
conversations regarding ICU recovery as well as with existing models of
survivorship.28 Recovery involves (1) integrated care, (2) strengthening the
continuity of care with stage-appropriate services from which to choose at
any point in the recovery process, (3) individualized and comprehensive
services across the lifespan, (4) inclusion of families for support of the
patient but also to address the needs of families and allies who struggle
during the recovery process, (5) commitment to peer recovery support
services, (6) ongoing monitoring and outreach, and (7) cultural
responsiveness (Figure 1). These key elements borrowed from existing care
models parallel priorities of recovery from critical illness that may help
guide our development of a more holistic recovery care model that
promotes health and wellness across the lifespan for survivors of critical
illness and their families and caregivers.
Figure 1. Core concepts of recovery from critical illness
POST-ICU RECOVERY CLINICS
Patients and families often leave the ICU with little understanding of how
to manage their complex medical needs. Post-ICU clinics have piloted
attempts to bridge the gap in care for ICU survivors and address the needs
of patients and families with PICS using a team-based approach of
professionals from diverse clinical disciplines (eg, medicine, psychology,
occupational therapy, physical therapy, pharmacy, social work). Post-ICU
clinics at select institutions in North America and Europe—developing
models of survivorship treatment grounded in the care of survivors with
other medical conditions such as cancer—have forged the way for these
novel care centers, which vary with regard to services provided.29-32 Many
post-ICU centers provide comprehensive assessments, with a focus on rapid
identification of areas of potential concern; incorporate brief, highly
effective clinical interventions; and facilitate referrals to outpatient
providers and community resources that will assist patients in reaching and
maintaining the highest possible level of recovery. Through this model,
patients and caregivers secure the opportunity to gain invaluable
understanding of their physical, psychological, cognitive, and functional
needs; engage in early and preventive treatments to mitigate detrimental
outcomes; secure long-term support throughout their lifelong recovery
process; and develop helpful and realistic expectations of the course of their
respective illnesses.
Current investigations of recovery clinics provide mixed but hopeful
findings and are subject to limitations such as small sample sizes and great
variability in services provided by ICU follow-up clinics.23,32-34 Promising
preliminary data from one trailblazing recovery center demonstrated that
collaborative care that included a physician, a nurse, a case manager, a
mental health professional, and others, when appropriate, improved
cognitive and functional outcomes of survivors who were seen in the
recovery clinic twice. Of note, the study also demonstrated the feasibility of
ICU recovery centers because the study population included “high-risk”
ICU survivors who, despite numerous barriers, were still able to actively
participate in treatment.35 Furthermore, the establishment of ICU recovery
clinics in mental health recovery is of great value because it provides the
opportunity to diagnose and treat psychological difficulties following ICU
hospitalization that may otherwise go undetected and untreated.
Consultations to address symptoms of PTSD through individualized
interventions have been associated with reduced symptoms of PTSD.36
Figure 2 provides examples of the ways that ICU recovery clinics could
affect patient care and patient outcomes.
Figure 2. Clinical vignettes from an ICU recovery center

A. Medication reconciliation and counseling find the patient to be taking a number of inappropriate
medications, including omeprazole and quetiapine, which were prescribed in the ICU. The
medications are stopped, decreasing the risk of Clostridium difficile colitis, QT prolongation, and
excess somnolence and freeing the patient from the financial burden of unnecessary medications.
B. Medical evaluation reveals abnormal spirometry, low oxygen saturation, and a hoarse, airy voice.
The patient is referred to voice clinic for airway evaluation and started on supplemental oxygen.
C. A patient is seen for a cognitive assessment and displays severe but previously unrecognized
cognitive impairment on screening tests of visuospatial and executive ability. He is advised not to
drive and is referred for a formal driving evaluation.
D. Six-minute walk distance is severely decreased and the patient is having difficulty caring for her
baby due to necrosis of the fingers and toes, a result of high-dose pressors in the ICU. Case
management evaluation reveals that the patient never received physical and occupational therapy
prescribed at discharge because she did not have a primary care physician to receive the
paperwork. The case manager arranges home therapy and assists the patient in finding an in-
network primary care physician.
E. At a patient-centered consultation, a review of spirometry shows early obstruction concerning for
smoking-related lung disease. The patient reveals that he stopped smoking in the ICU but has been
having cravings. After interdisciplinary review with psychology, pharmacy, and case management, a
smoking cessation plan with behavioral and pharmacological intervention is integrated into a
survivorship care plan.
No consensus is available regarding optimal services, treatment

interventions, or evaluation methods best suited for clinics serving ICU
survivors and families. Barriers to ICU follow-up clinics are numerous and
include limited resources, patient and provider level of awareness of long-
term difficulties, and lack of knowledge about the optimal interventions to
ensure successful recovery from critical illness.37,38 Future investigations
should verify the best practices in ICU follow-up clinics that will help
patients and families to manage physical debility, psychological distress,
and cognitive difficulties; navigate return-to-work and community
engagement options; and enhance quality of life.
EXPANDING THE INTERPROFESSIONAL TEAM

To address patient needs and provide individualized treatment plans, we
must additionally expand our interprofessional treatment team, which has
often been limited to providers from only a few disciplines. The impact of
critical care medicine relies heavily on the collaborative care within and
beyond the ICU. As we continue to recognize and address the vast needs of
ICU patients and survivors, we can rely on the expertise of our colleagues
through powerful relationships and formal integration of other providers
into the critical care team. The interprofessional approach has been shown
to improve outcomes in other populations including heart failure,
Parkinson’s disease, stroke, general medical illness, depression, and
cancer.39-45 In general, treatment teams—whether in the ICU or after—have
expanded considerably so that in postdischarge environments they include
specialists such as an acute care nurse practitioner, ICU pharmacist,
pulmonary intensivist, case manager, and neuropsychologist to better
identify needs of survivors after ICU discharge and coordinate a
comprehensive recovery treatment plan.46 Formal investigations are still
needed to characterize the impact of such interprofessional teams in ICU
recovery clinics, and the creation of an interprofessional team may vary
tremendously depending on the treatment setting and the additional
healthcare resources, or lack thereof, in the community. Of note, recovery
clinics may facilitate recovery from PICS with the inclusion of experts in
rehabilitation medicine, physical and occupational therapy, or social
workers who are well-versed in disability and return-to-work options
(Figure 3). Although including an interprofessional team in ICU recovery
clinics hold great promise in identifying and igniting recovery for ICU
survivors, recovery is a process that continues beyond the clinic setting to
promote greater integration of the patient into “normal” life. The
interprofessional team necessary for long-term recovery is likely to benefit
from a wide network of referrals that allow for individualizing treatment
plans and facilitating care and support in the community, ultimately
transitioning patients from a level of greater dependence on hospital
settings to increased independence and quality of life.
Figure 3. Interprofessional clinical teams for ICU recovery
Medicine (pulmonary, critical care, internal medicine, physical medicine and rehabilitation,
geriatrics, palliative care)
Psychology (neuropsychology, rehabilitation)
Nursing (advance expertise in critical care)
Pharmacy
Case management
ENHANCING RECOVERY THROUGH THE

COALESCENCE OF BEHAVIORAL AND CRITICAL CARE
MEDICINE
Interventions aimed at reducing psychological distress of survivors,
families, and caregivers have yielded great promise despite some concern
regarding limited or mixed evidence for incorporating psychological and
behavioral health interventions into treatment plans for patients and
survivors of critical illness. Nonetheless, over the last decade, a greater
emphasis has been placed on fostering resilience and empowering patients
through psychological interventions. Evidence-based treatments for
psychological disorders are plentiful, and the power of these interventions
relies, in part, on the proper implementation of these treatments with great
consideration of patient motivation and readiness, accurate diagnoses, and
appropriate referrals.
Intra-ICU psychological interventions have been largely neglected and
underexplored. Perhaps the most well-known psychological intervention to
date is the ICU diary, a tool to assist patients in understanding their critical
illness.47 ICU diaries are generally well-received and are perceived by
patients as providing comfort, encouragement, and hope.48 One randomized
controlled trial of ICU diaries reported reduced new-onset PTSD to 5% in
comparison to 13.1% in the control group.49 Despite disagreement among
researchers regarding some negative results of ICU diary studies, many
agree that the diaries appear promising in mitigating long-term psychiatric
difficulties in ICU survivors.50-52
Future endeavors for intra-ICU behavioral health interventions may
augment current practice in both the assessment and treatment of pain.53
Pain management increasingly involves and recognizes cognitive appraisals
of somatic experiences and psychological aspects of the pain experience.54
Psychological interventions including biofeedback, mindfulness-based
interventions, and cognitive behavioral therapy for chronic pain have been
used and explored in outpatient settings with promising results.55-57 Studies
indicate that mindfulness-based psychological interventions are associated
with reduced pain severity ratings and opioid use for pain management.58
Psychological interventions are more frequently used on burn units where
patients often experience significant levels of distress and pain despite
pharmacological interventions.59,60 However, psychological interventions
are underused in seemingly apropos pain management scenarios across
other ICUs where comprehensive pain management has great potential to
reduce patient distress, overuse of opioid medications, and associated
complications that otherwise increase the risk of PICS.
Future investigations are needed to understand the impact of early
psychological interventions, beyond the ICU diary, which may strengthen
the ability of the ICU Liberation Bundle to reduce post-ICU suffering.
Despite the general absence of psychologists in the ICU, investigations
have shed light on the value of psychological interventions and support for
a variety of ICU-relevant scenarios, including procedural anxiety and
psychological distress during hospitalization, which are associated with
immediate and long-term benefits.61,62 For example, a randomized
controlled trial of bedside psychological assessment and therapy in the ICU
reported a reduced risk of PTSD at 12 months after discharge.62 Complex
interventions may prove more person-centered and generalizable to a wider
population of ICU patients. Complex interventions that aim to create a
therapeutic environment, provide stress support, and promote relaxation and
recovery strategies are under development and investigation to bolster
coping strategies for distress in the ICU.63,64 Such early interventions allow
patients to build resilience throughout the recovery process, as many of the
skills acquired through intra-ICU psychological interventions easily
translate to other phases of recovery to promote healthy coping and
adjustment following discharge from the ICU.
Support groups are one avenue to increase social support and foster a
culture of resilience in survivors.10,65-67 Peer support groups have
demonstrated effectiveness in multiple clinical populations including cancer
survivors, patients with diabetes, and people with psychological and
substance use disorders.68-73 In addition to facilitating an exchange of
information and education about PICS and ICU survivorship, peer support
groups allow group members to address and overcome issues of identity in
the face of significant changes in physical, psychological, and cognitive
function; cultivate hope and optimism; and recreate and embrace meaning
in their lives. Unfortunately, despite patient testimonials and the alluring
benefit gleaned from other clinical populations, we lack an evidence base
for providing peer support to ICU survivors. However, the value of support
groups in recovery is less controversial, and as we embrace the long-term
and often lifelong recovery process for ICU survivors, we may recognize
that the inherent commonalities unifying survivors of cancer, critical illness,
and substance use disorder supersede their differences, warranting the
availability and investigation of ICU recovery support groups.
Patient peer mentorship also shows promise in helping survivors transition
from dependence on healthcare providers to a life with greater integration
with community resources, improved coping, and enhanced health
behavior.74-77 Through peer mentorship, an ICU survivor serves as a liaison
and resource of knowledge about recovery to a patient recently discharged
from the ICU to facilitate the often-challenging transition to life after
critical illness. In addition to promoting resilience and coping following
critical illness, both support groups and peer mentorship are well-suited
interventions to overcome key barriers to quality of life in ICU survivors—
a lack of awareness and understanding of PICS among ICU patients.78
It is important to conceptualize the evolving field of critical care, which
now envelopes treatment of long-term physical, cognitive, and
psychological difficulties through rehabilitation efforts and behavioral
medicine. The apparent value of treating psychological distress calls for
guidelines to promote psychological assessment of ICU patients and
survivors to ensure timely and appropriate referral in a patient-centered
manner.
ADDRESSING THE NEEDS OF FAMILIES AND

CAREGIVERS OF ICU PATIENTS AND SURVIVORS
The ICU Liberation Bundle includes the Family Engagement and
Empowerment component to address the essential role of families and
caregivers in the process of recovery from critical illness as well as the
persistent emotional difficulties experienced by family members who have
PICS (known as PICS-Family [PICS-F]).15 Building a relationship of trust
and compassion between patients, families, and healthcare providers can
promote patient-centered care during and after ICU hospitalization.
Enhanced communication with families improves satisfaction with care,
enhances understanding of patient health, and even reduces length of stay.79
At times, this communication can be impeded by mental health difficulties
(notably PTSD, which occurs in up to a third of spouses and children of
ICU survivors), and these problems can contribute to issues of attending,
focusing, and understanding complex medical information and decision
making. Although the emotional challenges experienced by family
members potentially impede patient care, they are problems in their own
right and frequently can be improved by thoughtfully delivered
psychological interventions. In light of this insight, it remains important for
providers to explicitly query family members about their adjustment and
coping and to recognize family members as individuals with their own
unique needs in addition to their relationship with the ICU patient of
interest.
Although evaluating the mental health needs of family members is
paramount, clinicians must address other practical concerns related to the
capacity of family members to provide supportive care. For example, the
spouse of a frail elderly man about to leave the ICU may herself be frail,
elderly, and ill, and despite her desire to care for her husband at home, she
may be ill equipped to do so. Carefully exploring issues related to caregiver
capacity and evaluating unmet needs of the patient and family are necessary
and ultimately helpful in determining what healthcare, local, or community-
based resources could be leveraged to reduce barriers to recovery, optimize
patient functioning and participation, and promote quality of life.
PATIENT-CENTERED CARE IN THE ICU

In a culture with such heavy emphasis on preserving life, we are challenged
to simultaneously prioritize patient autonomy and quality of life at every
stage of life for ICU patients and survivors.
Life, within which exists death and dying, is best experienced fully and
with compassionate care even when one is fighting critical illness. As ICU
providers to those walking the fine line between life and death, and to
patients and families who are often unexpectedly confronting the fragility
of human existence, we must not only heal ailments but also support a
human experience that is meaningful to patients as they move through life
and recovery. At times, this may mean pausing, allowing space for
contemplation of death and dying.83,84 Patients who do not have survivable
illness benefit substantially from patient-centered communication about
goals of care. For example, routine ICU family conferences and palliative
care consultation can facilitate patient and family decision making
regarding transition to comfort-focused care and forgoing of life-sustaining
treatment.85,86
Providing the means for patients and families to contemplate such life-
altering decisions is crucial to preserve a patient’s dignity and autonomy
while minimizing discomfort.25 Although some care settings readily use
palliative care services, these services are not ubiquitously available within
the ICU or thereafter. Few critical care teams formally incorporate a
palliative care provider into routine care of ICU patients, which leaves
patients more vulnerable to threats to autonomy and dignity. This highly
valued service provides the opportunity for quality, skilled communication
between providers, patients, and families and empowers patients and
families to maintain autonomy through active and thoughtful engagement in
healthcare decision making.87 When it is not feasible to incorporate
palliative care providers in critical care treatment plans, providing other
clinicians with training in communication of goals-of-care discussion and
symptom management may ease the family and patient distress from the
burden of such critical personal and healthcare decision making.90
CONSIDERATIONS FOR EQUITABLE IMPLEMENTATION

OF THE ICU LIBERATION BUNDLE
A persistent challenge related to the ICU Liberation Bundle is that, to date,
this model of care has been implemented primarily in sophisticated and
prosperous resource-rich environments. Although we believe that key
features of the bundle can be implemented across ICUs globally, this is
somewhat aspirational as the bundle remains untested in many contexts. A
key goal, then, is to test the bundle in diverse cross-cultural environments
and to determine which features of the bundle are portable and scalable and
can be most readily adapted for use in non-Western contexts. Finally, we
must reflect on whether there are aspects of the bundle that respond to
predominantly “local” as opposed to international sensitivities and whether
any aspects of the bundle are culturally bound. These efforts will promote
equitable delivery and access to critical care medicine and quality
healthcare while testing the global impact of our efforts.
SUMMARY
As described throughout this chapter, the care and management of critically
ill patients have undergone a radical and dramatic paradigm shift such that
current care extends far beyond a narrow focus on survival and reaches
toward the development of broader goals that involve quality of life after
critical illness. Quality of life, which includes an emphasis not only on
patients but on family members as well, appears to be enhanced by
implementation of the ICU Liberation Bundle, particularly when delivered
by robust interdisciplinary teams that draw on the collective wisdom and
insights of experts from widely varying backgrounds. Although the bundle
was originally designed as a set of interventions aimed largely at inpatient
care, it has now expanded to emphasize care of individuals long after
discharge by applying models such as ICU recovery centers and concepts of
recovery. These models have a long history with other medical populations
and have only recently been adapted for survivors of sepsis, acute
respiratory distress syndrome, multiple organ failure, and other expressions
of critical illness. As the field continues to evolve and expand, it is
important to acknowledge those stable attributes underlying great change.
Undoubtedly, the field of critical care medicine is characterized by an
immeasurable concern for survivor health and well-being and the respect
for human dignity, which continue to drive efforts to think strategically,
imaginatively, and compassionately about future improvement plans for an
even more comprehensive model of care that will empower ICU patients
and survivors to thrive.
KEY POINTS
The ICU Liberation Bundle is a living framework that must continue
to evolve, adapt to various environments, and become increasingly
patient-centered.
Redefining recovery, with consensus among providers, will unify our
efforts to promote the goals of ICU Liberation.
Principles shared by recovery-oriented and cancer survivorship models
can help expand the focus of critical care medicine from survival to
recovery of health and wellness.
Investigations of intra-ICU and post-ICU psychosocial interventions
hold great promise in mitigating long-term impairment in survivors of
critical illness.
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Copyright © 2020 Society of Critical Care Medicine, exclusive of any U.S. Government material.

All rights reserved.

Managing Editor: Kathy Ward

Printed in the United States of America

First Printing, May 2020

Society of Critical Care Medicine

500 Midway Drive

Phone +1 847 827-6869

International Standard Book Number: 978-1-620751-00-8

Jaspal Singh, MD, MHA, MHS, FCCM

Joanna L. Stollings, PharmD, FCCM, FCCP

Michele C. Balas, PhD, RN, CCRN-K, FCCM, FAAN

Mary Ann Barnes-Daly, MS, RN, CCRN-K, DC

Juliana Barr, MD, FCCM

Mélanie Bérubé, PhD, RN

Nathan E. Brummel, MD, MSCI

Judy E. Davidson, DNP, RN, MCCM, FCCM

John W. Devlin, PharmD, FCCM

E. Wesley Ely, MD, MPH

Heidi Engel, PT, DPT

Alix Fitzgerald, CCLS

Erika Gabbard, DNP, RN, CCNS, CCRN-K

Celine Gélinas, PhD, RN

Timothy D. Girard, MD, MSCI

Brent A. Hall, PharmD

Ken D. Hargett, MHA, RRT, FAARC, FCCM

Ramona O. Hopkins, PhD

James C. Jackson, PsyD

Ruth Kleinpell, PhD, RN, FCCM

Caroline L. Lassen-Green, PhD, MS

Geraldine Martorella, PhD, RN

Mark E. Mikkelsen, MD, MSCE

Giora Netzer, MD, MSCE

Pratik Pandharipande, MD, MSc

Brenda Pun, DNP, RN, FCCM

Kathleen Puntillo, PhD

George E. Ross, MBA, HCM, CPHQ

Paul M. Szumita, PharmD, FCCM

Hector R. Valdivia, ARNP

Kathleen Vollman, MSN, RN, CCNS, FCNS, FCCM, FAAN

Chris Winkelman, PhD, ACNP, CCRN, CNE, FCCM, FAANP

Jerry Zimmerman, MD, PhD, FCCM

Chapter 1: Introduction to the Bundle

Chapter 2: Assessment, Prevention, and Management of Pain

Chapter 3: Spontaneous Awakening and Breathing Trials

Chapter 4: Choice of Analgesia and Sedation

Chapter 5: Delirium Assessment, Prevention, and Management

Chapter 6: Early Mobility

Chapter 7: Family Engagement and Empowerment

Chapter 9: Strategies to Facilitate Effective Adoption of the ICU Liberation Bundle,

Chapter 13: Administrators’ Perspective on the ICU Liberation Bundle

Chapter 15: Future Directions for ICU Liberation

It is with great pleasure that we acknowledge the significant work of the

Describe appropriate pain assessment strategies for use in

Key words: pain, pain assessment, pain management, practice

Pain management remains a major issue in intensive care practice, which

Component Description Link With Pain Descriptors

Figure 1. Visual formats of the 0- to 10-point numeric rating scale

When Self-Report Is Not Possible, Use a Standardized Behavioral

Consult Family Members About the Patient’s Common Behaviors

Reproduced with permission. Copyright © 2016 Celine Gélinas, RN, PhD.

A systematic, standardized, interprofessional approach to pain management

Intervention Schedule or Dosage Pain Implementation Other Comments