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Johns Hopkins University

Armstrong Institute for
Patient Safety and Quality

SAT AND SBT PROTOCOL

DEFINITIONS FOR
CUSP FOR VAP: EVAP
Protocol Definitions and Recommendations for
Spontaneous Awakening Trials (SAT) and Spontaneous Breathing Trials (SBT)
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Table of Contents
I. JHU Armstrong Institute - Protocol for SAT and SBT

II. SAT and SBT Protocol Definitions for CUSP for VAP: EVAP
1. Recommendations by Boles, et al.
2. Summary of Pertinent Points by Girard, et al.
3. Spontaneous Awakening Trial (SAT)
4. Spontaneous Breathing Trial (SBT)
5. Results
6. Summary of Pertinent Points by Kress, et al.

III. References

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I. Johns Hopkins University Armstrong Institute -

Protocol for Spontaneous Awakening (SAT) and
Spontaneous Breathing Trial (SBT)

Spontaneous Awakening (SAT) and Spontaneous Breathing Trial (SBT) Protocol:

Introduction - Reducing the number of days a patient is on mechanical ventilation has been
shown to reduce the risk of VAP. (Ely 1996, Brook 1999, Kress 2000) Strategies for weaning
patients off of mechanical ventilation are often not handled well as the spontaneous awakening
(SAT) and spontaneous breathing trials (SBT) are viewed separately. A wake up and breathe
protocol using both the SAT and SBT can significantly reduce the number of days patients are
on mechanical ventilation. Girard et. al. showed that paired, the SAT and SBT reduced the
number of days patients were on mechanical ventilation (3.1 mean difference, 95% CI 0.7-5.6;
p=0.02), with a concomitant reduction in the length of hospital stay (4 day difference) when
compared to SBT alone. This same technique, often called a readiness-to-wean or sedation
protocol, has been used in other institutions with much success. (Kress 2000, Blackwood 2011,
Quenot 2007) We are using the model Girard et. al. developed in 2008 for this project.
A patient is considered to have passed the SAT if already awake, defined by Kress et. al. 2000 as
“They can do three out of four simple tasks on request: open their eyes, look at their caregiver,
squeeze the hand or put out their tongue.”
The SAT consists of two parts, a safety screen and the trial. (Please see flow diagram below.)
The safety screen attempts to assure the trials will not be used when contraindicated. Patients
pass the screen unless:
1. They are receiving a sedative infusion for active seizures or alcohol withdrawal
2. They are receiving escalating doses of sedative for agitation
3. They are receiving neuromuscular blockers
4. They have evidence of active myocardial ischemia in prior 24 hours
5. They have evidence of increased intracranial pressure

If the patient passes the safety screen, all sedatives and analgesics used for sedation are
stopped. Analgesics used for pain are continued. The goal is that the patient can do three out
of four simple tasks on request: open their eyes, look at their caregiver, squeeze the hand or
put out their tongue (Kress 2000) or can go without sedation for 4 hours or more without the
following:
1. sustained anxiety
2. agitation
3. pain
4. a respiratory rate of 35 breaths/minute for >= 5 minutes
5. an SpO2 of less than 88% for >=5 minutes
6. an acute cardiac dysrhythmia
7. two or more signs of respiratory distress
a. tachycardia

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b. bradycardia
c. use of accessory muscles
d. abdominal paradox
e. diaphoresis
f. marked dyspnea

If a patient fails the SAT, sedatives are started at one half the prior dosage and titrated up as
needed.
If a patient passes the SAT, the patient is assessed for the SBT safety screen. Patients pass if:
1. they have adequate oxygenation (SpO2 >=88% or an F1O2 of <=50% and a PEEP <=8 cm
H2O)
2. any spontaneous inspiratory effort in a 5-min period
3. no agitation
4. no significant use of vasopressors or inotropes
5. no evidence of increased intracranial pressure

If a patient fails the safety screen, he is reassessed for SAT the following day. If the patient
passes the safety screen, they undergo the SBT. Ventilatory support is removed. Patient is
allowed to breathe through either a T-tube circuit of a ventilatory circuit with CPAP of 5cm H2O
or pressure support ventilation of less than 7cm H2O. Patients pass the trial if they don’t
develop any of the following failure criteria for 120 minutes.
1. respiratory rate of more than 35 or less than 8 breaths per min for 5 min or longer
2. hypoxemia (SpO2 < 88% for >=5 min)
3. abrupt change in mental status
4. an acute cardiac arrhythmia
5. two or more signs of respiratory distress
a. tachycardia
b. bradycardia
c. use of accessory muscles
d. abdominal paradox
e. diaphoresis
f. marked dyspnea

If a patient fails the SBT, he is reassessed for SAT the following day. If a patient passes the SBT,
the patient’s physicians are notified for possible extubation.

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II. Spontaneous Awakening Trials (SAT) and Spontaneous

Breathing Trials (SBT) Protocol Definitions for a
Comprehensive Unit-Based Safety Program (CUSP) for
Ventilator- Associated Pneumonia (VAP): Eliminate
Ventilator-Associated Pneumonia (EVAP)

Our protocol is based on the Boles and Girard articles below. We feel that these have the
strongest evidence for the parameters for an SBT.

Boles, et. al.1 – Recommendations from this Review Article:

Link:
http://www.ersj.org.uk/content/29/5/1033.full.pdf+html

This is a Review.

“Weaning should be considered as early as possible in patients receiving mechanical

ventilation; a majority of patients can be successfully weaned on the first attempt. SBT is the
major diagnostic test to determine if patients can be successfully extubated. The initial SBT
should last 30 min and consist of either T-tube breathing or low levels of PS (5–8 cmH2O in
adults; f10 cmH2O in paediatric patients) with or without 5 cmH2O PEEP. SIMV should be
avoided as a weaning modality. Weaning protocols are most valuable in hospitals in which
physicians otherwise do not adhere to standardized weaning guidelines.”

Girard, et. al.2 - Summary of Pertinent Points:

Link:
http://www.sciencedirect.com/science/article/pii/S0140673608601051

This is a randomized controlled trial. Outcomes are comparing use of the SBT vs. SAT and SBT
combined. SBT and SAT below are from the same protocol.

“Numerous randomized trials support the use of ventilator weaning protocols that
include daily spontaneous breathing trials (SBTs) as their centrepiece; such protocols are
standard of care, having reduced the duration of mechanical ventilation in diverse populations
of patients with acute respiratory failure.3, 4, 4-8 Recent clinical trials, seeking to identify ways to
manage sedation that might also facilitate earlier extubation, have shown that both
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intermittent use of sedatives and spontaneous awakening trials (SATs)—ie, daily interruption of
sedatives—can reduce the duration of mechanical ventilation without compromising patient
comfort or safety.9-11The paucity of additional evidence supporting the routine use of SATs,
however, as well as anecdotal concerns regarding patient safety and agitation, have led to
limited use of this sedation strategy. Whereas some intensive-care practitioners report only
lightly sedating patients during most of their time on the ventilator, less than half of
practitioners worldwide have implemented daily interruption of sedatives—eg. 34% in
Germany,16 40% in Canada,17 and 40% in the USA.12, 13 Also, proponents of patient-targeted
sedation strategies argue that titration of sedatives according to patients’ needs produces
outcomes equivalent to those resulting from a protocol that promotes daily SATs.14, 15”

Spontaneous Awakening Trials (SAT):

“In accordance with the SAT protocol, patients in the intervention group were assessed
every morning with an SAT safety screen. SATs were prescribed by protocol only for patients in
the intervention group, although patients in the control group were not prevented from
undergoing SATs if the managing clinician felt that they were indicated. Patients passed the
screen unless they were receiving a sedative infusion for active seizures or alcohol withdrawal,
were receiving escalating sedative doses due to ongoing agitation, were receiving
neuromuscular blockers, had evidence of active myocardial ischaemia in the previous 24 h, or
had evidence of increased intracranial pressure. Patients who failed the screen were reassessed
the following morning.
Patients who passed the screen underwent an SAT: all sedatives and analgesics used for
sedation were interrupted. Analgesics needed for active pain were continued. Patients were
monitored by intensive-care staff or study personnel for up to 4 h. Patients passed the SAT if
they opened their eyes to verbal stimuli or tolerated sedative interruption for 4 h or more
without exhibiting failure criteria. Patients failed the SAT if they developed sustained anxiety,
agitation, or pain, a respiratory rate of more than 35 breaths per min for 5 min or longer, an
SpO2 of less than 88% for 5 min or longer, an acute cardiac dysrhythmia, or two or more signs
of respiratory distress, including tachycardia, bradycardia, use of accessory muscles, abdominal
paradox, diaphoresis, or marked dyspnoea. When patients failed an SAT, intensive-care staff
restarted sedatives at half the previous dose and then titrated the medications to achieve
patient comfort. Patients who passed the SAT were immediately managed with the SBT
protocol.”

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Spontaneous Breathing Trials (SBT):

“In accordance with the SBT protocol, patients in the control group were assessed every
morning with an SBT safety screen. Patients passed the screen if they had adequate
oxygenation (oxygen saturation [SpO2] ≥88% on a fraction of inspired oxygen [FIO2] ≤50% and a
positive end-expiratory pressure [PEEP] ≤8 cm H2O), any spontaneous inspiratory effort in a 5-
min period, no agitation, no evidence of myocardial ischaemia in the previous 24 h, no
significant use of vasopressors or inotropes (dopamine or dobutamine ≥5 μg/kg per min,
norepinephrine ≥2 μg/min, or vasopressin or milrinone at any dose), and no evidence of
increased intracranial pressure. Patients who failed the screen were reassessed the following
morning.
Patients who passed underwent an SBT: ventilatory support was removed, and the
patient was allowed to breathe through either a T-tube circuit or a ventilatory circuit with
continuous positive airway pressure of 5 cm H2O or pressure support ventilation of less than 7
cm H2O.22 No change was made in FIO2 or PEEP during the SBT. Patients failed the SBT if they
developed a respiratory rate of more than 35 or less than eight breaths per min for 5 min or
longer, hypoxaemia (SpO2 <88% for ≥5 min), abrupt changes in mental status, an acute cardiac
arrhythmia, or two or more signs of respiratory distress, including tachycardia (>130 bpm),
bradycardia (<60 bpm), use of accessory muscles, abdominal paradox, diaphoresis, or marked
dyspnoea. Patients who failed the SBT were ventilated immediately with the ventilator settings
used before the trial. Patients passed the SBT if they did not develop any failure criteria during
a 120-min trial. If the SBT was successful, the patients’ physicians were notified verbally.”

Results:
“150 (90%) patients in the intervention group passed an SAT safety screen; these
patients underwent 895 SATs (table 2). Analgesics were continued for pain during 132 (15%) of
these SATs. Clinicians discontinued the sedatives administered to 52 (31%) patients in the
control group before at least one SBT (table 2). The number of patients in each group treated
with benzodiazepines, opiates, or propofol was similar, as was the cumulative dose of propofol
(table 2). The cumulative benzodiazepine dose was higher in the control group than in the
intervention group. Only 45 (27%) patients in the control group and 31 (18%) patients in the
intervention group received haloperidol (p=0・07).
Patients in the intervention group spent more days breathing without assistance than
those in the control group (3・1 mean ventilator-free days diff erence, 95% CI 0・7–5・6;
p=0・02; table 3). Additionally, the intervention protocol resulted in discharge about 4 days
earlier from both intensive care and from the hospital (table 3 and figure 3). There was no
significant interaction between study centre and treatment with respect to the number of
ventilator-free days (data not shown). The duration of coma was significantly shorter in the
intervention group than in the control group, whereas the duration of delirium was similar
between the two groups (table 3). Of the assessable patients, delirium occurred in 124 (74%) in
the intervention group and 119 (71%) in the control group (p=0・66).”

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Kress, et. al.10 – Summary of Pertinent Points:

Link:
http://www.nejm.org/doi/full/10.1056/NEJM200005183422002

Each day, we assessed each patient’s mental status with respect to wakefulness. A
patient was considered “awake” if he or she was able to perform at least three of the following
four actions, which could be assessed objectively: open the eyes in response to a voice, use the
eyes to follow the investigator on request, squeeze a hand on request, and stick out the tongue
on request.

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III. References

1. Boles JM, Bion J, Connors A, et al. Weaning from mechanical ventilation. Eur Respir J.
2007;29(5):1033-1056. doi: 10.1183/09031936.00010206.

2. 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(9607):126-134. doi:
10.1016/S0140-6736(08)60105-1.

3. Ely EW, Baker AM, Dunagan DP, et al. Effect on the duration of mechanical ventilation of
identifying patients capable of breathing spontaneously. N Engl J Med. 1996;335(25):1864-
1869. doi: 10.1056/NEJM199612193352502.

4. MacIntyre N. Evidence-based guidelines for weaning and discontinuing ventilatory support: A

collective task force facilitated by american college of chest physicians; the american
association for respiratory care; American College of Critical Care Medicine. Chest.
2001;120:375-396.

5. 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(6):345-
350. doi: 10.1056/NEJM199502093320601.

6. Kollef MH, Shapiro SD, Silver P, et al. A randomized, controlled trial of protocol-directed
versus physician-directed weaning from mechanical ventilation. Crit Care Med. 1997;25(4):567-
574.

7. Marelich GP, Murin S, Battistella F, Inciardi J, Vierra T, Roby M. Protocol weaning of

mechanical ventilation in medical and surgical patients by respiratory care practitioners and
nurses: Effect on weaning time and incidence of ventilator-associated pneumonia. Chest.
2000;118(2):459-467.

8. Lellouche F, Mancebo J, Jolliet P, et al. A multicenter randomized trial of computer-driven

protocolized weaning from mechanical ventilation. Am J Respir Crit Care Med. 2006;174(8):894-
900. doi: 10.1164/rccm.200511-1780OC.

9. Brook AD, Ahrens TS, Schaiff R, et al. Effect of a nursing-implemented sedation protocol on
the duration of mechanical ventilation. Crit Care Med. 1999;27(12):2609-2615.

10. Kress J, Pohlman A, O'Connor M, Hall J. Daily interruption of sedative infusion in critically ill
undergoing mechanical ventilation. N.Engl.J.Med. 2000;342:1471-1477.

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11. Carson SS, Kress JP, Rodgers JE, et al. A randomized trial of intermittent lorazepam versus
propofol with daily interruption in mechanically ventilated patients. Crit Care Med.
2006;34(5):1326-1332. doi: 10.1097/01.CCM.0000215513.63207.7F.

12. Tanios M, de Wit M, Epstein S, Devlin J. Perceived barriers to the use of sedation protocols
and daily sedation interruption: A multidisciplinary survey. Journal Critical Care. 2009;24:66-73.

13. Devlin JW, Tanios MA, Epstein SK. Intensive care unit sedation: Waking up clinicians to the
gap between research and practice. Crit Care Med. 2006;34(2):556-557.

14. Hong JJ, Mazuski JE, Shapiro MJ. Daily interruption of sedative infusions in critically ill
patients. N Engl J Med. 2000;343(11):814; author reply 814-5. doi:
10.1056/NEJM200009143431114.

15. Heffner JE. A wake-up call in the intensive care unit. N Engl J Med. 2000;342(20):1520-1522.
doi: 10.1056/NEJM200005183422011.

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