PADIS Guidelines Teaching Slides Sedation

Agitation/Sedation
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
Introduction
2018 pain, agitation/sedation, delirium, immobility, and sleep disruption
(PADIS) guidelines
• Update of 2013 PAD guidelines by:

– Adding 2 new topics: rehabilitation/mobilization and sleep disruption
– Including patients as collaborators and coauthors
– Adding experts from Europe and Australia
• 37 recommendations and two ungraded good practice statements

– Only 2 of 37 recommendations rated as “strong”
• 32 ungraded statements (nonactionable descriptive questions)
Slide development by: R. Nikooie, MD, C. Chessare, MS, D. Needham, MD, PhD
© Society of Critical Care Medicine.

All rights reserved.
Methods
• Grading of Recommendations Assessment, Development, and Evaluation
(GRADE) methodology
• Chairs, section heads, panel members, ICU survivors, librarian
• Topics selected and prioritized, PICO questions finalized, and then:
– Literature review: 5 electronic databases, 1990 to October 2015
– Evaluation of study (primarily RCT) methodologic rigor: risk of bias
– Formulation of preliminary recommendations: GRADE evidence-to-
decision process
– In-person discussion among full panel (SCCM 2017 Congress)
– Anonymous recommendation voting
– > 80% agreement with > 70% response rate
– 100% of the panel voted (with reminders and prompts)
• ICU survivors participated in every step
Devlin JW, et al. PADIS Method Innovations Paper. Crit Care Med 2018; 46:1457-1463

Formulate Select Rate Systematic Evidence profile 1 Pooled estimate of effect per outcome
question outcomes importance review 2 Quality of evidence per outcome
High
High| Moderate Low|Very low
Moderate | Low
Very low
Outcome1 Critical RCT high
Patient, start observational low
intervention, Outcome2 Critical
comparison, 1. Risk of bias
outcome Outcome3 Important
rate down
2. Inconsistency
(PICO)
Outcome4 Not 3. Indirectness
question
imp 4. Imprecision
ort
an 5. Publication bias
t
Exclude 1. Large effect
rate up
2. Dose response
3. Antagonistic bias
systematic review of evidence
Evidence-to-Decision (EtoD)
framework:
 Balance
benefits/downsides Rate overall quality of
 Quality of evidence evidence
 Values and preferences across outcomes
 Resource use (cost) Section Panel Members
 Feasibility
 Acceptability
Formulate preliminary Large Electronic voting
recommendation group (blinded to
 For or against an action discussion others voting)
 Strong or conditional
(strength)
© Society of Critical Care Medicine. Final recommendation
Slide courtesy of Waleed Alhazzani, MD, MSc
Strong Versus Conditional Recommendations
Strong Conditional
Patients Applies to almost all patients Applies to most patients
(significant exceptions based on patient
condition, values, and preferences)
Supporting Moderate- to high-quality Conflicting, low quality, insufficient,
evidence across broad populations and/or limited populations
Benefits versus Benefits clearly outweigh May be close balance between benefits
burdens burdens and burdens
Influence of future Limited potential to change Possible/probable potential to change
research recommendation recommendation
Performance or Can be readily adapted in Requires significant deliberation at the
quality indicators most healthcare systems local level based on practice patterns,
patients served, and resource
availability
Balas MC, Weinhouse GL, Denehy L, et al. Interpreting and implementing the 2018 pain, agitation/sedation, delirium, immobility, and sleep disruption
clinical practice guidelines. Crit Care Med. 2018 Sep;46(9):1464-1470.

PICO and Descriptive Questions for PADIS Clinical Practice Guideline
Pain Agitation/Sedation Delirium Immobility Sleep
(Rehab/Mobilization) Disruption
Factors that influence pain Light vs. deep sedation Delirium prediction Rehab/mobilization Comparison of sleep in critically
(performed in or out of bed) ill adults vs.:
Assessment Prevalence, rationale, and • Risk factors vs. different • Healthy adults
• Patient self-report outcomes of physical restraint • Influence of level of rehab/mobilization • Delirium (vs. no delirium)
• Behavioral use arousal on delirium intervention, placebo, or • MV (vs. no MV)
• Proxy reporters assessment sham Prevalence of unusual sleep
• Physiologic measures • Outcomes of delirium
Protocol-based assessment and Daily sedation interruption vs. Delirium assessment using Harm associated with Physiologic/nonphysiologic sleep
management: nurse-protocolized sedation valid tool (vs. no rehab/mobilization (either in monitoring
• Analgesia first assessment) or out of bed)
• Analgosedation
Multimodal analgesia to reduce Mechanically ventilated patients Pharmacologic prevention: Clinical indicators to safely Risk factors affecting ICU sleep
opioid use: after cardiac surgery: • Haloperidol initiate rehab/mobilization quality:
• Acetaminophen • Propofol vs. benzodiazepines • Atypical antipsychotic (either in or our of bed) • Before critical illness
• Nefopam • Statin • ICU-acquired
• Ketamine • Dexmedetomidine Disrupted sleep outcomes:
• Neuropathic analgesia • Ketamine • During ICU admission
• IV lidocaine • After ICU discharge
• NSAID
Procedural analgesia: Mechanically ventilated critically Pharmacologic treatment: Clinical indicators to stop Pharmacologic sleep
• Opioid vs. none ill adults: • Haloperidol rehab/mobilization improvement:
• High- vs. low-dose opioid • Propofol vs. benzodiazepines • Atypical antipsychotic (either in or out of bed) • Melatonin
• Local analgesia • Dexmedetomidine vs. • Statin • Dexmedetomidine
• Nitrous oxide benzodiazepines • Dexmedetomidine • Propofol
• Isoflurane • Propofol vs. • Ketamine
• NSAID (systemic/gel) dexmedetomidine
Nonpharmacologic analgesic Objective sedation monitoring Nonpharmacologic delirium Nonpharmacologic sleep

strategies: tools reduction interventions: improvement:
• Cybertherapy/hypnosis • Single component: Bright • AV vs. PS mode
• Massage light therapy • Adaptive vs. PS mode
• Music • Multicomponent: • Aromatherapy
• Cold therapy ABCDEF bundle • Music
• Relaxation techniques • Noise and light reduction
• Multimodal protocol

Agitation/Sedation
• Sedatives may predispose patients to increased morbidity.
– Must determine specific indication for use (is pain present?)
– Assess sedation status frequently using a valid/reliable scale (e.g. RASS)
– Critically ill patients are prone to increased adverse events because of:
o Reduced drug clearance, unpredictable response, baseline hemodynamic
instability
2013 Guidelines
• Improving patients’ short-term outcome by:
– Targeting light levels of sedation or daily awakening trials
– Minimizing benzodiazepines
2018 Guidelines
• Improving post-ICU outcomes by:
– Sedation delivery paradigm and specific sedative medication choice
• 3 actionable (PICO) questions plus 3 descriptive questions

Light Versus Deep Sedation
PICO Question
P Critically ill adults

Lightly sedated (Richmond Agitation-Sedation Scale [RASS] = –2 to +1 or
I equivalent)
(*DIS/SAT studies not included)
C Deeply sedated
•90-day mortality •Time to extubation •Delirium
O •Tracheostomy •Cognitive and physical function decline*
•Depression •Posttraumatic stress disorder (PTSD)
Rationale: 8 RCTs, 3 observational studies.

*No randomized controlled trials (RCTs) evaluated post-ICU cognitive or physical functioning.

• Time to extubation (3 RCTs, 453 patients, low quality)
– Associated with shorter time, MD –0.77 days (95% CI, –2.04 to 0.50)
• Time to extubation (3 observational studies, 1,524 patients, low quality)

– Associated with shorter time, MD –3.46 days (95% CI, –5.70 to –1.23)

• Tracheostomy rate (1 RCT and 1 observational study, 452 patients)

– Reduced, RR 0.57 (95% CI, 0.41 to 0.80)
• Light sedation was not associated with reduction in:

– Delirium (2 RCTs, 140 patients), RR 0.96 (95% CI, 0.80 to 1.16)
– PTSD (2 RCTs, 62 patients), RR 0.67 (95% CI, 0.12 to 3.79)
– Depression (2 RCTs, 128 patients), RR 0.76 (95% CI, 0.10 to 5.58)

• 90 days mortality (2 RCTs, 324 patients)
– Not significant, RR 1.01 (95% CI, 0.80 to 1.27, low quality)
• Self-extubation (4 RCTs, 546 patients)

– Not significant, RR 1.29 (95% CI, 0.58 to 2.88, low quality)

Recommendation:
We suggest using light (vs. deep) sedation in critically ill, mechanically ventilated
adults (conditional recommendation, low quality of evidence).
Evidence gaps:
• There is no consensus on definitions of light, moderate, and deep sedation.
• The relationship between changing sedation levels over time and clinical
outcomes remains unclear.
• The effect of light sedation on post-ICU, patient-specific factors needs to be
evaluated in RCTs.
• There is a dearth of information about interactions between sedative choice,
depth, and patient-specific factors.

Daily Sedation Interruption Versus
Nurse-Protocolized Sedation
Descriptive Question:
In critically ill intubated adults, is there a difference between daily sedation
interruption (DSI) protocols and nurse-protocolized targeted sedation in the
ability to achieve and maintain a light level of sedation?
A DSI or spontaneous awakening trial (SAT) is a period of time during which a

patient’s sedative medication is discontinued so the patient can wake up and
achieve arousal and/or alertness defined by objective actions (opening eyes in
response to a voice, following simple commands, and/or RASS score of −1 to +1.
Nurse-protocolized targeted sedation is an an established protocol used by a

bedside nurse to titrate sedatives to an established sedation goal. Note that the
frequency of assessment and sedative titration often vary considerably.

Daily Sedation Interruption Versus
Nurse-Protocolized Sedation
Data: 5 unblinded RCTs compared DSI to either usual or nurse-protocolized targeted
sedation (739 patients, usually a benzodiazepine with or without an opioid)
– While differences exist among individual RCTs regarding the ability of DSI (vs. its
comparator) to maintain light sedation, the overall ability of DSI and nurse-
protocolized targeted sedation to achieve light sedation is similar.
– Both DSI and nurse-protocolized targeted sedation are safe.
Ungraded statement:
DSI protocols and nurse-protocolized targeted sedation can achieve and maintain a light
level of sedation.
Evidence gaps:
– Variability exists in nursing sedation assessment frequency and reporting.
– Variability exists in sedative administrative routes among institutions.
– Patient and family preferences and education should be considered.

Choice of Sedative: Cardiac surgery
Question: Should propofol, as compared to a benzodiazepine, be used for sedation in
mechanically ventilated adults after cardiac surgery?
Note: Clinical significance was defined (for the evidence evaluated) as a shortened time to light sedation of ≥ 30
minutes and a shortened time to extubation of ≥ 1 hour.
• Time to extubation (7 RCTs, 409 patients)

– Reduced by 1.4 hours (95% CI, −2.2 to −0.64, low quality)
Time to light sedation (2 RCTs, 70 patients)

– Reduced by 52 minutes (95% CI, −77.5 to −26.2, low quality)

All rights reserved. Slide development by: R. Nikooie, MD, C. Chessare, MS, D. Needham, MD, PhD
Choice of Sedative: Cardiac surgery
Recommendation:
We suggest using propofol over a benzodiazepine for
sedation in mechanically ventilated adults after cardiac
surgery (conditional recommendation, low quality of
evidence).

Choice of Sedative:
Medical and Surgical Patients (Noncardiac Surgery)
Question: For sedation in critically ill mechanically ventilated adults:
1. Should propofol, as compared to a benzodiazepine, be used?
2. Should dexmedetomidine, as compared to a benzodiazepine, be used?
3. Should dexmedetomidine, as compared to propofol, be used?
Clinical significance was defined (for the evidence evaluated) as:

• a shortened time to light sedation of ≥ 4 hours
• a shortened time to extubation of ≥ 8-12 hours (one nursing shift)

Choice of Sedative:
Propofol versus benzodiazepine:
• Time to extubation (10 RCTs, 423 patients)
– Reduced by 11.6 hours (95% CI, −15.6 to −7.6, low quality)
Note: Benzodiazepines are nearly always administered as continuous infusions.


Choice of Sedative:
Propofol versus benzodiazepine:
• Time to light sedation (10 RCTs, 357 patients)
– Reduced by 7.2 hour (95% CI, −8.9 to −5.5, low quality)
Note: Benzodiazepines are nearly always administered as continuous infusions.


Choice of Sedative:
Dexmedetomidine versus benzodiazepine:
• No significant benefit of dexmedetomidine (vs. benzodiazepine) infusion for:
• Duration of mechanical ventilation (5 RCTs, 1,052 patients)
– MD −0.7 days (95% CI, −1.9 to 0.5, low quality)
• ICU length of stay (3 RCTs, 969 patients)
– MD −0.2 days (95% CI, −0.6 to 0.1, low quality)
• Risk of delirium (4 RCTs, 1,007 patients)
– RR 0.8 (95% CI, 0.6 to 1.08, low quality)
Dexmedetomidine versus propofol:

• No significant difference in time to extubation (3 RCTs, 850 patients)
• No data available for other outcomes

Recommendation:
We suggest using either propofol or dexmedetomidine over benzodiazepines
for sedation in critically ill mechanically ventilated adults (conditional
recommendation, low quality of evidence).
Evidence Gaps:
• Effect of sedative choice on longer-term, patient-centered outcomes needs to be
investigated; a reliance on evaluating faster extubation no longer suffices.
• Patient perceptions, including their ability to communicate, while on different
sedatives, needs to be evaluated.
• Pharmacology of sedatives and their delivery methods needs to be considered.
• Cost considerations are important and often vary among different countries.
• Sedative choice in the context of analgosedation needs further evaluation.
• Choice of sedative in certain patient subgroups needs further evaluation.
– Neurologically injured hemodynamically unstable patients needing deep
sedation

Objective Sedation Monitoring
Are objective sedation monitoring tools (EEG-based tools or tools such as heart rate
variability, actigraphy, and evoked potentials) useful in managing sedation in critically ill
intubated adults?
Data: 32 ICU-based studies
• Subjective scales have limited use in deep sedation (reach their minimum values).
• Objective tools have limited use in increasing agitation (reach their maximum values).
• Objective tools (such as bispectral index [BIS]) allow measurements without
stimulating the patient.
Ungraded statements:
1. BIS monitoring is best suited for sedative titration during deep sedation or
neuromuscular blockade.
2. Sedation monitored with BIS compared to subjective scales may improve sedative
titration when a sedative scale cannot be used.

Physical Restraints
What are the prevalence rates, rationale, and outcomes (harm and benefit)
associated with physical restraint use in intubated or nonintubated critically
ill adults?
Rationale:
• No RCTs have explored safety and efficacy.
• Use varies from 0 in some European countries to 75% in North America.
• Historically used to:
– enhance patient safety and prevent falls
– prevent self-extubation or tube or device dislodgement or removal
– control patient behavior and protect staff from combative patients
• Paradoxically higher event rate with restraint use found in some
descriptive studies

Physical Restraints
Ungraded statements:
. . . frequently used for critically ill adults, although prevalence rates vary
greatly by country . . . to prevent self-extubation and medical device
removal, avoid falls, and to protect staff . . . despite a lack of studies
demonstrating efficacy and the safety concerns associated with physical
restraints (e.g., unplanned extubation, greater agitation).
Evidence gaps:
• Effect of nursing staffing pattern, family and patient advocacy, and staff
education
• Necessity and ethics of physical restraint during end-of-life care
• Effect on patient-important outcomes

PADIS Guideline Authors
1
John W. Devlin, PharmD (Chair for Overall CPG)
2
Yoanna Skrobik, MD, MSc (Vice-Chair)
21
Dale M. Needham, MD, PhD (Chair, Immobility)
3
Céline Gélinas, RN, PhD (Chair, Pain) 22
Linda Denehy, PT, PhD
4
Aaron M. Joffe, DO 23
Michelle E. Kho, PT, PhD
5
Kathleen A. Puntillo RN, PhD 24
Chris Winkelman, RN, PhD
6
Gerald Chanques, MD, PhD 25
Nathaniel E. Brummel, MD, MSCI
7
Jean-Francois Payen, MD, PhD 26
Jocelyn Harris, OT, PhD
8
Paul M. Szumita, PharmD 27
Julie Lanphere, DO
28
Sina Nikayin, MD (research staff)
9
Pratik P. Pandharipande, MD, MSCI(Chair, Sedation)
10
Richard R. Riker, MD 29
Paula L. Watson, MD, MPH (Co-Chair, Sleep)
11
Michele C. Balas, RN, PhD 30
Gerald L. Weinhouse, MD (Co-Chair, Sleep)
12
Yahya Shehabi, MD, PhD 31
Xavier Drouot, MD, PhD
13
John P. Kress, MD 32
Karen Bosma, MD
14
Bryce R.H. Robinson MD, MS 33
Sharon McKinley, RN, PhD
15
Arjen Slooter, MD, PhD (Chair, Delirium) 34
Waleed Alhazzani, MD, MSc (Chair, Methods)
16
Brenda T. Pun, RN, DNP 35
Mark E. Nunnally, MD
17
Gilles L. Fraser, PharmD, MCCM 36
Bram Rochwerg, MD, MSc
18
Margaret Pisani, MD, MPH 37
John E. Centofanti, MD, MSc
19
Karin J. Neufeld, MD, MPH
20
Mark van den Boogaard, RN, PhD 38
Carrie Price, MLS (medical librarian)
39
Cheryl J. Misak, PhD (patient rep)
40
Ken Kiedrowski, MA (patient rep)
41
Pamela Flood, MD (patient rep)

Acknowledgement
Slide content has been provided by the

PADIS Guideline Leadership.

For more information on how to implement the 2018
PADIS guidelines, please visit the ICU Liberation
Campaign website: http://www.sccm.org/ICULiberation


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Agitation/Sedation

2018 SCCM Clinical Practice Guidelines for the

• Update of 2013 PAD guidelines by:

• 37 recommendations and two ungraded good practice statements

• 32 ungraded statements (nonactionable descriptive questions)

© Society of Critical Care Medicine.

© Society of Critical Care Medicine.

© Society of Critical Care Medicine.

Nonpharmacologic analgesic Objective sedation monitoring Nonpharmacologic delirium Nonpharmacologic sleep

© Society of Critical Care Medicine.

© Society of Critical Care Medicine.

P Critically ill adults

•90-day mortality •Time to extubation •Delirium

O •Tracheostomy •Cognitive and physical function decline*

•Depression •Posttraumatic stress disorder (PTSD)

Rationale: 8 RCTs, 3 observational studies.

© Society of Critical Care Medicine.

• Time to extubation (3 observational studies, 1,524 patients, low quality)

© Society of Critical Care Medicine.

• Tracheostomy rate (1 RCT and 1 observational study, 452 patients)

• Light sedation was not associated with reduction in:

© Society of Critical Care Medicine.

• Self-extubation (4 RCTs, 546 patients)

© Society of Critical Care Medicine.

© Society of Critical Care Medicine.

A DSI or spontaneous awakening trial (SAT) is a period of time during which a

Nurse-protocolized targeted sedation is an an established protocol used by a

© Society of Critical Care Medicine.

© Society of Critical Care Medicine.

• Time to extubation (7 RCTs, 409 patients)

Time to light sedation (2 RCTs, 70 patients)

© Society of Critical Care Medicine.

© Society of Critical Care Medicine.

Question: For sedation in critically ill mechanically ventilated adults:

1. Should propofol, as compared to a benzodiazepine, be used?

2. Should dexmedetomidine, as compared to a benzodiazepine, be used?

3. Should dexmedetomidine, as compared to propofol, be used?

Clinical significance was defined (for the evidence evaluated) as:

© Society of Critical Care Medicine.

Note: Benzodiazepines are nearly always administered as continuous infusions.

© Society of Critical Care Medicine.

Note: Benzodiazepines are nearly always administered as continuous infusions.

© Society of Critical Care Medicine.

Dexmedetomidine versus propofol:

© Society of Critical Care Medicine.

© Society of Critical Care Medicine.

© Society of Critical Care Medicine.

© Society of Critical Care Medicine.

© Society of Critical Care Medicine.

© Society of Critical Care Medicine.

Slide content has been provided by the

© Society of Critical Care Medicine.

© Society of Critical Care Medicine.

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