Daily Sedation Interruption: Is it Necessary?
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1 Daily Sedation Interruption: Is it Necessary? Geeta Mehta MD, FRCPC Mount Sinai Hospital Critical Care Canada Forum October 31, 2012
2 Disclosures I have no disclosures
3 Is daily sedation interruption necessary?
4 Is daily sedation interruption necessary?
5 Is daily sedation interruption necessary?
6 Daily Interruption of Sedation 150 Mechanically Ventilated patients Usual care Daily sedation interruption MDs made decisions RN directed Re-titration Ramsay score Single center No surgical pts PI involvement Kress JP et al. NEJM 2000;342:1471
7 Daily Interruption of Sedation 10 p = p = Days Interruption Contol 2 0 Duration of MV ICU LOS Kress JP et al. NEJM 2000;342:1471
8 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
9 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
10 336 MV patients Usual care and SBT SAT and SBT 4 centers Validated sedation scale Lancet 2008;371:126
11 ABC Trial Extubation ICU Discharge
12 ABC Trial Extubation DI group: More self-extubations ICU Discharge
13 ABC Trial NNT 7
14 Crit Care MV patients Sedation protocol Daily Interruption
15 Crit Care MV patients Sedation protocol Daily Interruption 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)
16 Crit Care MV patients Sedation protocol Daily Interruption 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)
17 medical, surgical, neurosurgical patients DI or usual care Propofol & remifentanyl
18 Duration of Mechanical Ventilation
19 Endotracheal tube removal
20 Risk of Tracheostomy
21
22 How often do clinicians interrupt sedation?
23 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.
24 Stated use in Canada: 2009 vs % 70% 60% 50% 29% 49% 40% 40% 30% 20% 3% 10% 0% Sedation Protocol NMBA Protocol Sedation Scale Pain Scale Delirium Scale Daily Interrruption 2009: 51 ICUs, 712 pts, 3621 pt-days Burry et al. Proc ATS 2009; 179:A5492
25 Stated use in Canada: 2009 vs % 70% 60% 50% 40% 30% 29% 49% ACTUAL PRACTICE 2009 Titration to protocol 18% Sedative interrupted 32% Analgesic interrupted 14% 40% 20% 3% 10% 0% Sedation Protocol NMBA Protocol Sedation Scale Pain Scale Delirium Scale Daily Interrruption 2009: 51 ICUs, 712 pts, 3621 pt-days
26 Scale Protocol DI Varney Gill 12 US 50% 36% Burry 09 Canada Saluh 09 Brazil Patel 09 USA O Connnor 09 Australia Reschreiter 08 UK Martin 07 Germany Payen 07 France Mehta 06 Canada Tanios 06 US Egerod 05 Denmark
27 Why don t clinicians interrupt sedation?
28 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
29 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) FIO 2 > 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
30 Other concerns about DI Workload Surgical patients Withdrawal syndromes Patient Memories PTSD
31 Postal survey 386 hospitals Respondent: lead infection control professional BMJ Quality Safety 2012
32 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 Available at jamanetwork.com
33 N= centers Surgical and medical pts ITT All patients managed with RN driven sedation/analgesia protocol randomized Daily interruption Sedation/analgesia No daily interruption
34 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
35 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)
36 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
37 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 opening 2) tracking 3) hand squeezing 4) 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
38
39
40 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%
41 Baseline Characteristics Admission Diagnosis (N) Bacterial/viral pneumonia Non-urinary sepsis Other respiratory disease Aspiration pneumonia COPD Post operative respiratory disease PS + DI N= PS N= MV days prior to randomization 2 (1,4) 2 (1,4) Opioid infusions at randomization (%) Days, median Benzodiazepine infusions at randomization (%) Days, median 87% 1 (1,3) 81% 1 (1,3) 89% 1 (1,3) 80% 1 (1,3)
42 Outcomes
43 Kaplan-Meier Curves - Time to Successful Extubation Sedation Protocol Sedation Protocol + Daily Interruption Proportion successfully extubated HR % CI 0.86,1.35 P=0.495 P=0.495 No. of patients at risk Sedation Protocol Sedation Protocol + Daily Interruption Time, days
44 Duration of MV and Lengths of Stay 24 P= Days P=.52 P=.36 PS 8 PS+DI 4 0 MV ICU LOS Hospital LOS
45 Opioid and benzodiazepine use PS+DI PS P value N=214 N=209 Midazolam equivalents (mg) Dose/patient/day 102 (326) 82 (287) 0.04 Infusion, days 5.7 (6.4) 5.6 (5.9) Boluses/day 0.25 (1.1) 0.18 (0.81) Fentanyl equivalents (mcg) Dose/patient/day 1780 (4135) 1070 (2066) <.0001 Infusion, days 6.4 (6.9) 6.6 (6.2) Boluses/day 2.2 (2.9) 1.8 (2.7) <.0001
46 SLEAP Secondary outcomes PS+DI N=214 PS N=209 P Device removal Gastric tube 18 (8.5%) 29 (13.9%).08 ETT 10 (4.7%) 12 (5.7%).64 Urinary catheter 6 (2.8%) 13 (6.2%).09 C-line or A-line 17 (8.0%) 10 (4.8%).18 Neuro-imaging CT 29 (13.6%) 33 (15.9%).53 MR 9 (4.2%) 7 (3.4%).64
47 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
48 Reasons for non-interruption of infusions 6% 4% 4% 3% 3% 38% Ventilation Agitation/pain Day 1 of study Missed 11% Hemodynamics Airway hemorrhage 14% MD request 17% Palliative Other
49 Nurse Visual Analogue Scale How difficult was the patient s management during your shift? PS PS+DI % of scores Very Fairly Somewhat Difficult Easy Easy Difficult N > 8000
50 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
51 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.
52
53 RN and MD opinions about DI All p<.001 % RN MD 0 Appropriate sedation Undersedation Like using DI
54 Nurses who disliked DI (N = 32) 80% 70% 60% 50% 40% 30% 20% 10% 0% Discomfort Inappropriate pt Workload Less control Coordinate Inappropriate-all Too awake Anxious to leave room
55 Concerns about DI % RN MD 0 Resp Pain/ Agitation Device Cardiac Psychological compromise discomfort Removal instability consequences
56 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%)
57 Is daily sedation interruption necessary?
58 NO YES If patients kept lightly sedated SLEAP and SR: no difference in MV days higher daily opioid and benzodiazepine doses Perception of higher nurse workload
59 Thank-you!
60
61 Sedation-agitation scale 7 Dangerous Pulling ET, trying to remove catheters, climbing bed agitation rail, 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
62 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 (eyeopening/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
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