Daily Sedative Interruption in Critically Ill Patients Being Managed With a Sedation Protocol. (SLEAP)
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About
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.
Full 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.
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Inclusion and exclusion criteria
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
410 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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