Daily Sedative Interruption in Critically Ill Patients Being Managed With a Sedation Protocol.
- Conditions
- Critical Illness
- Interventions
- Procedure: Protocolized SedationProcedure: Protocolized sedation, with daily interruption
- Registration Number
- NCT00675363
- Lead Sponsor
- Mount Sinai Hospital, Canada
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 410
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PS Protocolized Sedation Nurse-directed protocols for administering sedation and/or analgesia by continuous infusion. PS + DI Protocolized sedation, with daily interruption Nurse-directed protocols for administering sedation and/or analgesia, with daily interruption of sedation/analgesia
- Primary Outcome Measures
Name Time Method time to successful extubation 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
Name Time Method ICU and hospital lengths of stay, ICU and hospital mortality, Adverse events (e.g., self -removal of endotracheal tube) 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.
Trial Locations
- Locations (16)
Surrey Memorial Hospital
🇨🇦Vancouver, British Columbia, Canada
Providence Health Care-St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Tuft's Medical Centre
🇺🇸Boston, Massachusetts, United States
Royal Alexandra Hospital
🇨🇦Edmonton, Alberta, Canada
Winnipeg Health Sciences Centre
🇨🇦Winnipeg, Manitoba, Canada
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
St. Joesph's Healthcare
🇨🇦Hamilton, Ontario, Canada
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Maisonneuve Rosemount
🇨🇦Montreal, Quebec, Canada
Walter C. Mackenzie Health Sciences Centre
🇨🇦Edmonton, Alberta, Canada
Royal Columbian Hospital
🇨🇦New Westminster, British Columbia, Canada
Long Beach Memorial Medical Center
🇺🇸Long Beach, California, United States
Sunnybrook HSC
🇨🇦Toronto, Ontario, Canada