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Critical Care Canada ForumOctober 31, 2012
Daily Sedation Interruption:Is it Necessary?
Geeta Mehta MD, FRCPC
Mount Sinai Hospital
Disclosures
• I have no disclosures
Is daily sedation interruption
necessary?
Is daily sedation interruption
necessary?
Is daily sedation interruption
necessary?
Daily Interruption of Sedation
Kress JP et al. NEJM 2000;342:1471
150 Mechanically
Ventilated patients
Daily sedation
interruption
RN directed
Re-titration Ramsay
score
Usual care
MDs made
decisions
Single center
No surgical pts
PI involvement
Daily Interruption of Sedation
0
2
4
6
8
10
Interruption
Contol
Duration of MV ICU LOS
Days
p = 0.004 p = 0.02
Kress JP et al. NEJM 2000;342:1471
4.9
7.36.4
9.9
Daily Interruption of Sedation
• Hospital LOS: no difference
• midazolam dose by 50%
• Days awake 85% vs 9% p<.001
• Fewer neurologic tests
• DI: 6 CT
• Control: 15 CT, 2 MRI, 1 LP p=.02
• No increase in adverse events
Kress et al. NEJM 2000
Psychological impact of daily interruption
Kress JP et al. AJRCCM 2003;168:1471
• Reduced symptoms of PTSD
DI and complications of critical illness
Schweikert et al. Crit Care Med 2004;32:1272
“Complications”: VAP, UGIB, bacteremia, barotrauma, VTE,
cholestasis, sinusitis
• DI 13 (2.8%) vs Control 26 (6.2%) p=.04
DI in patients at risk for CAD
Kress JP et al. Crit Care Med 2007;35:365
• Not associated with myocardial ischemia
Lancet 2008;371:126
336 MV patients
SAT
and
SBT
Usual care
and
SBT
4 centers
Validated sedation scale
ABC TrialExtubation
ICU
Discharge
ABC Trial
DI group: More
self-extubations
Extubation
ICU
Discharge
ABC Trial
NNT 7
74 MV patients
Daily
Interruption
Sedation
protocol
Crit Care 2008
74 MV patients
Daily
Interruption
Sedation
protocol
Interim analysis - DMC terminated trial
Daily interruption group
• More MV days (median 6.7 vs 3.9)
• Slower improvement of SOFA
• Longer ICU and hospital LOS
• (Higher mortality – and no causal link)
Crit Care 2008
74 MV patients
Daily
Interruption
Sedation
protocol
Interim analysis - DMC terminated trial
Daily interruption group
• More MV days (median 6.7 vs 3.9)
• Slower improvement of SOFA
• Longer ICU and hospital LOS
• (Higher mortality – and no causal link)
Crit Care 2008
2009
97 medical, surgical ,
neurosurgical patients
DI or usual care
Propofol & remifentanyl
Duration of Mechanical Ventilation
Endotracheal tube removal
Risk of Tracheostomy
How often do clinicians
interrupt sedation?
A Canadian survey of the use of sedatives, analgesics,
and neuromuscular blocking agents in critically ill patients.
S Mehta, L Burry, S Fischer, C Martinez-Motta, D Hallett,
D Bowman, C Wong, M Meade, T Stewart, and D Cook,
for the Canadian Critical Care Trials Group
Critical Care Medicine 2006;34:374
A prospective evaluation of sedative, analgesic, anti-psychotic,
and paralytic prescribing practices in Canadian mechanically
ventilated adults.
L Burry, M Perreault, D Williamson, D Cook, Z Wong, R Pinto,
H Rodrigues, C Either, K Bandayrel, A Little, F Quittnat,
N Ferguson, S Mehta.
Proc American Thoracic Society 2009; 179:A5492.
2004
2009
Stated use in Canada: 2009 vs 2004
0%
10%
20%
30%
40%
50%
60%
70%
80%
Sedation
Protocol
NMBA Protocol Sedation Scale Pain Scale Delirium Scale Daily
Interrruption
29%
49%
3%
40%
2009: 51 ICUs, 712 pts, 3621 pt-days Burry et al. Proc ATS 2009; 179:A5492
Stated use in Canada: 2009 vs 2004
0%
10%
20%
30%
40%
50%
60%
70%
80%
Sedation
Protocol
NMBA Protocol Sedation Scale Pain Scale Delirium Scale Daily
Interrruption
29%
49%
3%
40%
2009: 51 ICUs, 712 pts, 3621 pt-days
ACTUAL PRACTICE 2009
Titration to protocol 18%
Sedative interrupted 32%
Analgesic interrupted 14%
Varney Gill 12 US 50% 36%
Burry 09 Canada 18 32
Saluh 09 Brazil 88 53 32
Patel 09 USA 88 71 22
O’Connnor 09 Australia 75 54 20
Reschreiter 08 UK 88 80 78
Martin 07 Germany 46 52 34
Payen 07 France 28 36 0
Mehta 06 Canada 49 29 40
Tanios 06 US 64 40
Egerod 05 Denmark 44 23 31
Scale Protocol DI
Why don’t clinicians
interrupt sedation?
Perceived barriers
Daily sedation interruption– Lack of nursing acceptance (20%)
– Patients pulling out lines and tubes (20%)
– Respiratory compromise (19%)
– Compromising patient comfort (19%)
– Observer availability (12%)
Sedation protocol– Lack of physician order (35%)
– Not applicable to clinicians’ own patients (25%)
– Lack of nursing support (11%)
– Fear of oversedation (7%)
Tanios et al. J Crit Care 2009;24:66
Willingness of nurses to perform daily
interruption
Nurse factors associated with willingness– Previous personal performance of DI (P<.0001)
– Perception of patient stability (P=.03)
– Not targeting deep sedation (SAS ≤ 2) (P=.03)
Patient factors associated with RN willingness– Older patient (P=.02)
– Diagnosis of sepsis (P=.04)
Patient factors associated with RN unwillingness– higher dose of continuous midazolam (P=.006) or fentanyl (P=.008)
– FIO2 > 50% (P = .03)
– PEEP > 5 mmHg (P =.006)
– Patient currently deeply sedated (SAS ≤ 2) (P =.05)
– Agitation (SAS ≥ 5) in prior 24 hrs (P=.003) or 48 hrs (P = .01)
Roberts et al. J Crit Care 2010
Other concerns about DI
• Workload
• Surgical patients
• Withdrawal syndromes
• Patient Memories
• PTSD
BMJ Quality Safety 2012
Postal survey
386 hospitals
Respondent: lead
infection control
professional
jamanetwork.com
Available at www.jama.com
S Mehta and coauthors
Daily Sedation Interruption in
Mechanically Ventilated Critically Ill
Patients Cared for With a Sedation
Protocol: A Randomized Controlled
Trial
Published online October 17, 2012
All patients managed
with RN driven
sedation/analgesia protocol
Daily interruption
Sedation/analgesiaNo daily interruption
randomized
N=430
16 centers
Surgical and
medical pts
ITT
Eligibility
Inclusion criteria
• 18 years
• MV and anticipated need for MV ≥ 48 hours
• ICU team has decided to initiate continuous opioid and/or benzodiazepine infusion(s)
Exclusion criteria• Admission after cardiac arrest • Traumatic Brain Injury• Receiving Neuromuscular blockers • Withdrawal or limitation of life support• Previous enrolment in SLEAP• Enrolment in confounding trial• Lack of informed consent
Primary Outcome
Duration of MV: from intubation to extubation or tracheostomy mask, for 48 hours
Secondary outcomes
Lengths of ICU/hospital stay
Opioid/benzodiazepine use
Nurse and Respiratory Therapist Workload
Unintentional device removal
Physical Restraint
Delirium – Intensive Care Delirium Screening Checklist
Neurological evaluation (CT/MRI, EEG, LP, consult)
Both groups…
Nurse-implemented algorithm for management of analgesia and sedation
Analgesia: morphine, fentanyl or hydromorphone
Sedation: midazolam or lorazepam
Sedation Scale: SAS 3 or 4 or RASS 0 to -3
Ventilator Weaning protocol
Daily interruption group
Bedside nurses interrupted opioid and benzodiazepine infusions daily
Assessed hourly for wakefulness: SAS 4-7 (RASS -1 to +4) and able to perform at least 3 of:
1) eye opening2) tracking3) hand squeezing4) toe moving
If infusions no longer required (patient free of discomfort and agitation, SAS 2-5, or RASS -4 to +1), oral or bolus IV therapy used
If infusions required, resumed at half prior dose(s), titrated to achieve target level of light sedation
Baseline Characteristics
PS + DI
N=214
PS
N=209
Age (years) 57 (46,70) 60 (49,70)
Female 43.5% 44.0%
APACHE II 24 (18,28) 23 (19,29)
SOFA Score 7 (5,10) 6 (4,9)
Type of admission
Medical
Surgical
Trauma
81.8%
14.5%
3.7%
86.1%
11.0%
2.9%
Baseline Characteristics
PS + DI
N=214
PS
N=209
Admission Diagnosis (N)
Bacterial/viral pneumonia
Non-urinary sepsis
Other respiratory disease
Aspiration pneumonia
COPD
Post operative respiratory disease
39
40
22
11
4
7
47
36
21
4
10
7
MV days prior to randomization 2 (1,4) 2 (1,4)
Opioid infusions at randomization (%)
Days, median
87%
1 (1,3)
89%
1 (1,3)
Benzodiazepine infusions at randomization (%)
Days, median
81%
1 (1,3)
80%
1 (1,3)
Outcomes
0 5 10 15 20 25
0.2
0.4
0.6
0.8
1.0
Time, daysNo. of patients at risk
Sedation Protocol
Sedation Protocol
+ Daily Interruption
209
214
146
140
72
81
49
42
34
28
23
16
Sedation Protocol
Sedation Protocol + Daily Interruption
P=0.495
Kaplan-Meier Curves - Time to Successful Extubation
HR 1.08
95% CI 0.86,1.35
P=0.495Proportion
successfully
extubated
0
4
8
12
16
20
24
PS
PS+DI
MV ICU LOS Hospital
LOS
Duration of MV and Lengths of Stay
Days P=.36
P=.42
P=.52
Opioid and benzodiazepine use
PS+DI
N=214
PS
N=209
P value
Midazolam equivalents (mg)
Dose/patient/day
Infusion, days
Boluses/day
102 (326)
5.7 (6.4)
0.25 (1.1)
82 (287)
5.6 (5.9)
0.18 (0.81)
0.04
0.007
Fentanyl equivalents (mcg)
Dose/patient/day
Infusion, days
Boluses/day
1780 (4135)
6.4 (6.9)
2.2 (2.9)
1070 (2066)
6.6 (6.2)
1.8 (2.7)
<.0001
<.0001
SLEAP – Secondary outcomes
PS+DI
N=214
PS
N=209P
Device removal
Gastric tube
ETT
Urinary catheter
C-line or A-line
18 (8.5%)
10 (4.7%)
6 (2.8%)
17 (8.0%)
29 (13.9%)
12 (5.7%)
13 (6.2%)
10 (4.8%)
.08
.64
.09
.18
Neuro-imaging
CT
MR
29 (13.6%)
9 (4.2%)
33 (15.9%)
7 (3.4%)
.53
.64
SLEAP – Secondary outcomes
PS+DI
N=214
PS
N=209
P
Delirium 113 (53%) 113 (54%) .83
Physical restraint 161 (76%) 163 (79%) .46
Tracheostomy 49 (23%) 54 (26%) .46
ICU Mortality 50 (23%) 52 (25%) .72
Hospital Mortality 63 (30%) 63 (30%) .89
3%3%4%4%
6%
11%
14%
17%
38%
Ventilation
Agitation/pain
Day 1 of study
Missed
Hemodynamics
Airway hemorrhage
MD request
Palliative
Other
Reasons for non-interruption of infusions
Very Fairly Somewhat Difficult
Easy Easy Difficult
% of
scores
Nurse Visual Analogue Scale
How difficult was the patient’s management during your shift?
0
10
20
30
1 2 3 4 5 6 7 8 9 10
PS PS+DI
N > 8000
Nurse Visual Analogue Scale
How difficult was the patient’s management during your shift?
Mean VAS score
PS+DI 4.22 vs PS 3.80
Mean diff 0.41, 95% CI 0.17 to 0.66; P=0.001
Clinicians’ perspectives on a sedation
protocol and daily interruption for
mechanically ventilated patients
enrolled in SLEAP
L Burry, M Steinberg, L Rose, S Kim, J Devlin, B Ashley, O Smith,
K Poretta, Y Lee, J Harvey, M Brown, P Cheema, Z Wong, S Mehta
for the SLEAP Investigators & Canadian Critical Care Trials Group.
Intensive Care Medicine 2011; 37(1): S83.
0
20
40
60
80
100
RN
MD
Appropriate
sedation
Under-
sedation
Like using
DI
RN and MD opinions about DI
%
All p<.001
0%
10%
20%
30%
40%
50%
60%
70%
80%
Discomfort
Inappropriate pt
Workload
Less contro
l
Coordinate
Inappropriate-a
ll
Too awake
Anxious to le
ave room
Nurses who disliked DI (N = 32)
0
10
20
30
40
50
60
70
80
RN
MD
Concerns about DI
%
Resp Pain/ Agitation Device Cardiac Psychological
compromise discomfort Removal instability consequences
DI and Self-Extubation
Study Control DI
Kress 00 4/60 (7%) 3/68 (4%)
Carson 06 4/132 (3%)
Anifantaki 07 0/48 0/49
Girard 08 6/168 (3.6%) 16/168 (9.5%)
DeWit 08 4/38 (1%) 1/36 (2.8%)
Mehta 08 3/33 (9%) 3/32 (9%)
Mehta 12 10/214 (4.7%) 12/209 (5.7%)
Total 27/561 (4.8%) 39/694 (5.6%)
Is daily sedation interruption
necessary?
• If patients kept lightly
sedated
• SLEAP and SR:
– no difference in MV days
– higher daily opioid and
benzodiazepine doses
– Perception of higher
nurse workload
NO YES
Sedation-agitation scale
7 Dangerous Pulling ET, trying to remove catheters, climbing bed agitationrail, striking staff, thrashing
6 Very agitated Not calm, despite verbal reminding; requires physical restraints, biting ET tube
5 Agitated Mildly agitated, attempting to sit up, calms with verbal instructions
4 Calm and cooperative Calm, awakens easily, follows commands
3 Sedated Difficult to arouse, awakens to verbal stimuli or gentle shaking but drifts off again, follows simple commands
2 Very sedated Arouses to physical stimuli but does not communicate nor follow commands, may move spontaneously
1 Unarousable Minimal or no response to noxious stimuli, does not communicate nor follow commands
Riker RR et al. Crit Care Med 1999;27:1325
Richmond Agitation Sedation Scale
+4 Combative Overtly combative, violent, immediate danger to staff
+3 Very agitated Pulls or removes tube(s) or catheter(s); aggressive
+2 Agitated Frequent non-purposeful movement, fights ventilator
+1 Restless Anxious but movements not aggressive, vigorous
0 Alert and Calm Difficult to arouse, awakens to verbal stimuli or gentle shaking but drifts off again, follows simple commands
-1 Drowsy Not fully alert, but has sustained awakening (eye-opening/eye contact) to voice (≥ 10 seconds)
-2 Light Sedation Briefly awakens with eye contact to voice (< 10 seconds)
-3 Moderate Sedation Movement or eye opening to voice (but 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
Sessler CN et al. AJRCCM 2002;166:1338
