- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00675363
Daily Sedative Interruption in Critically Ill Patients Being Managed With a Sedation Protocol (SLEAP)
March 22, 2018 updated by: Sangeeta Mehta, Mount Sinai Hospital, Canada
A Randomized Trial of Daily Sedative Interruption in Critically Ill, Mechanically Ventilated Patients Being Managed With a Sedation Protocol
The purpose of this study is to determine whether the use of both a nurse-driven sedation protocol and daily sedative interruption, compared with a sedation protocol alone, result in better outcomes for mechanically ventilated adults.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
All critically ill, mechanically ventilated patients in the Intensive Care Unit receive medications to relieve pain and anxiety.
However, accumulation of these medications can be associated with serious complications, most notably longer time on the breathing machine and in the ICU.
Two strategies have been shown to dramatically improve patient outcomes: nurse-directed protocols for giving sedation, and daily interruption of sedation.
However, these strategies have not been widely adopted, because of physicians' concerns, and because it is unclear which strategy is better.
Given that patient outcome is improved with either of these strategies, the fundamental question that arises is whether patients managed with a combination of two strategies which both reduce drug accumulation (protocolized sedation and daily interruption) have an even better outcome than patients managed with only one of them (protocolized sedation).We are conducting a multicenter randomized trial in which 400 critically ill, mechanically ventilated patients will have their sedation managed with protocolized sedation alone, or both strategies.
Primary outcomes are duration of mechanical ventilation and ICU and hospital lengths of stay.
Secondary outcomes are the incidence of delirium, the use of neurologic tests, nurse and respiratory therapist effort associated with the sedation management, the incidence of patient self-removal of lines and tubes, and patient recall of the ICU stay.
The results of this large multi-center trial will help to inform best practice with regard to sedation management of critically ill patients in Canada and elsewhere.
Study Type
Interventional
Enrollment (Anticipated)
410
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada, T5H 3V9
- Royal Alexandra Hospital
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Edmonton, Alberta, Canada, T6G 2B7
- Walter C. Mackenzie Health Sciences Centre
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-
British Columbia
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New Westminster, British Columbia, Canada, V3L 3W7
- Royal Columbian Hospital
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Vancouver, British Columbia, Canada, V3W 1Z2
- Surrey Memorial Hospital
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Vancouver, British Columbia, Canada, V6Z 1Y6
- Providence Health Care-St. Paul's Hospital
-
-
Manitoba
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Winnipeg, Manitoba, Canada, R3A 1R9
- Winnipeg Health Sciences Centre
-
-
Ontario
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Hamilton, Ontario, Canada, L8L 2X2
- Hamilton Health Sciences
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Hamilton, Ontario, Canada, L8N 4A6
- St. Joesph's Healthcare
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Toronto, Ontario, Canada, M5B 1W8
- St. Michael's Hospital
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Toronto, Ontario, Canada, M5T 2S8
- Toronto Western Hospital
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Toronto, Ontario, Canada, M5G 2N2
- Toronto General Hospital
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Toronto, Ontario, Canada, M5G 1X5
- Mount Sinai Hospital
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook HSC
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Quebec
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Montreal, Quebec, Canada, H1T 2M4
- Maisonneuve Rosemount
-
-
-
-
California
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Long Beach, California, United States
- Long Beach Memorial Medical Center
-
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Massachusetts
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Boston, Massachusetts, United States
- Tuft's Medical Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years of age or over
- Mechanically ventilated, with anticipated need for MV ≥48 hrs
- ICU team has decided to initiate continuous sedative/analgesic infusion(s)
- informed consent from patient and/or SDM
Exclusion Criteria
- Admission after resuscitation from cardiac arrest
- Traumatic brain injury
- Currently receiving neuromuscular blocking agents
- Allergy to midazolam and lorazepam
- Lack of commitment to aggressive treatment
- Previous enrolment in SLEAP, or current enrolment in related trial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: PS
Nurse-directed protocols for administering sedation and/or analgesia by continuous infusion.
|
Nurse-directed protocol for administering sedation and/or analgesia.
|
Active Comparator: PS + DI
Nurse-directed protocols for administering sedation and/or analgesia, with daily interruption of sedation/analgesia
|
Nurse-directed protocols for administering sedation and/or analgesia, with daily interruption of sedation/analgesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
time to successful extubation
Time Frame: This will be the length of time that the patient remains on continuous infusions of sedation and/or analgesia in the ICU. At 60 days, all study interventions will terminate, but patients will be followed for outcomes.
|
This will be the length of time that the patient remains on continuous infusions of sedation and/or analgesia in the ICU. At 60 days, all study interventions will terminate, but patients will be followed for outcomes.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
ICU and hospital lengths of stay, ICU and hospital mortality, Adverse events (e.g., self -removal of endotracheal tube)
Time Frame: This will be the length of time that the patient remains on continuous infusions of sedation and/or analgesia in the ICU. At 60 days, all study interventions will terminate, but patients will be followed for outcomes.
|
This will be the length of time that the patient remains on continuous infusions of sedation and/or analgesia in the ICU. At 60 days, all study interventions will terminate, but patients will be followed for outcomes.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sangeeta Mehta, M.D., Mount Sinai Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Mehta S, Meade M, Burry L, Mallick R, Katsios C, Fergusson D, Dodek P, Burns K, Herridge M, Devlin JW, Tanios M, Fowler R, Jacka M, Skrobik Y, Olafson K, Cook D; SLEAP Investigators and the Canadian Critical Care Trials Group. Variation in diurnal sedation in mechanically ventilated patients who are managed with a sedation protocol alone or a sedation protocol and daily interruption. Crit Care. 2016 Aug 1;20(1):233. doi: 10.1186/s13054-016-1405-3.
- Rose L, Burry L, Mallick R, Luk E, Cook D, Fergusson D, Dodek P, Burns K, Granton J, Ferguson N, Devlin JW, Steinberg M, Keenan S, Reynolds S, Tanios M, Fowler RA, Jacka M, Olafson K, Skrobik Y, Mehta S. Prevalence, risk factors, and outcomes associated with physical restraint use in mechanically ventilated adults. J Crit Care. 2016 Feb;31(1):31-5. doi: 10.1016/j.jcrc.2015.09.011. Epub 2015 Sep 25.
- Burry L, Cook D, Herridge M, Devlin JW, Fergusson D, Meade M, Steinberg M, Skrobik Y, Olafson K, Burns K, Dodek P, Granton J, Ferguson N, Jacka M, Tanios M, Fowler R, Reynolds S, Keenan S, Mallick R, Mehta S; SLEAP Investigators; Canadian Critical Care Trials Group. Recall of ICU Stay in Patients Managed With a Sedation Protocol or a Sedation Protocol With Daily Interruption. Crit Care Med. 2015 Oct;43(10):2180-90. doi: 10.1097/CCM.0000000000001196.
- Rose L, Fitzgerald E, Cook D, Kim S, Steinberg M, Devlin JW, Ashley BJ, Dodek P, Smith O, Poretta K, Lee Y, Burns K, Harvey J, Skrobik Y, Fergusson D, Meade M, Kraguljac A, Burry L, Mehta S; SLEAP Investigators; Canadian Critical Care Trials Group. Clinician perspectives on protocols designed to minimize sedation. J Crit Care. 2015 Apr;30(2):348-52. doi: 10.1016/j.jcrc.2014.10.021. Epub 2014 Oct 30.
- Mehta S, Burry L, Cook D, Fergusson D, Steinberg M, Granton J, Herridge M, Ferguson N, Devlin J, Tanios M, Dodek P, Fowler R, Burns K, Jacka M, Olafson K, Skrobik Y, Hebert P, Sabri E, Meade M; SLEAP Investigators; Canadian Critical Care Trials Group. Daily sedation interruption in mechanically ventilated critically ill patients cared for with a sedation protocol: a randomized controlled trial. JAMA. 2012 Nov 21;308(19):1985-92. doi: 10.1001/jama.2012.13872. Erratum In: JAMA. 2013 Jan 16;309(3):237.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
October 17, 2012
Study Registration Dates
First Submitted
May 7, 2008
First Submitted That Met QC Criteria
May 8, 2008
First Posted (Estimate)
May 9, 2008
Study Record Updates
Last Update Posted (Actual)
March 23, 2018
Last Update Submitted That Met QC Criteria
March 22, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 85487
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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