Daily Sedative Interruption in Critically Ill Patients Being Managed With a Sedation Protocol
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | January 2008 |
| End Date: | October 17, 2012 |
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.
protocol and daily sedative interruption, compared with a sedation protocol alone, result in
better outcomes for mechanically ventilated adults.
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.
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.
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
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