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ISRCTN
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ISRCTN83837813
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ClinicalTrials.gov identifier
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Public title
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SLEAP: a randomised trial of daily sedative interruption in critically ill, mechanically ventilated patients being managed with a sedation protocol
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Scientific title
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Acronym
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SLEAP
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Serial number at source
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MCT-85487
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Study hypothesis
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To determine whether critically ill, mechanically ventilated adults managed with protocol-directed sedation and daily sedation interruption spend less time on the ventilator and in the intensive care unit (ICU) than patients managed with protocol-directed sedation alone.
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Ethics approval
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Ethics approval received from the Research Ethics Board of Mount Sinai Hospital (Toronto) on the 29th November 2007 (ref: 07-0281-A).
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Study design
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Concealed, unblinded, randomised, multicentre trial
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Mechanical ventilation
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Participants - inclusion criteria
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1. Aged greater than or equal to 18 years
2. Mechanically ventilated, with anticipated need for mechanical ventilation greater than or equal to 48 hours
3. ICU team has decided to initiate continuous sedative/analgesic infusion(s)
4. Informed consent
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Participants - exclusion criteria
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1. Admission after resuscitation from cardiac arrest
2. Traumatic brain injury
3. Currently receiving neuromuscular blocking agents (but these patients may be enrolled after these agents are discontinued)
4. Allergy to midazolam and lorazepam
5. Lack of commitment to aggressive treatment
6. Current enrolment in a related trial
7. Previous enrolment in this trial
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Anticipated start date
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01/01/2008
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Anticipated end date
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01/06/2010
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Status of trial
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Ongoing
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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410
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Interventions
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Experimental group:
Protocol-directed sedation and daily sedation interruption while patient is mechanically ventilated and receiving intravenous sedation infusions.
Control group:
Protocol-directed sedation while patient is mechanically ventilated and receiving intravenous sedation infusions.
Both groups will have sedation and analgesia managed according to their assigned strategy for the duration of their infusions of sedation and/or analgesia in the ICU. At 60 days, all study interventions (e.g., charting of sedation-agitation scale [SAS] and daily data collection) will cease, but patients will be followed for outcomes (e.g., duration of mechanical ventilation [MV], lengths of stay).
SLEAP takes place primarily in the ICU setting. All study interventions and data collection (e.g., charting of SAS or Richmond Agitation Sedation Scale [RASS], and daily data) (Daily Data Forms 4 to 7) will continue while patients are mechanically ventilated and receiving infusions of sedatives/analgesics. If patients remain ventilated and receiving infusions at 60 days, study interventions will cease, but patients will be followed to document clinical outcomes (e.g., duration of MV, ICU and hospital length of stay). Research Coordinators will not record daily data after discontinuation of drug infusions, but will interview patients on days 3 and 28, and 3 months after ICU discharge, to determine recall of ICU events.
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Primary outcome measure(s)
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Time to successful extubation measured from intubation to extubation or tracheostomy mask for 48 hours.
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Secondary outcome measure(s)
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1. ICU and hospital mortality, patients will be followed until hospital discharge or death
2. ICU and length of hospital stay, patients will be followed until hospital discharge or death
3. Adverse events (e.g., self-removal of endotracheal tube), measured while in ICU, receiving sedative/analgesic infusions, and being managed with the SLEAP sedation strategy
4. Delirium, as assessed by the Intensive Care Delirium Screening Checklist, measured while in ICU, receiving sedative/analgesic infusions, and being managed with the SLEAP sedation strategy
5. Reintubation and tracheostomy rates, measured while in ICU, receiving sedative/analgesic infusions, and being managed with the SLEAP sedation strategy
6. Neurologic function, measured while in ICU, receiving sedative/analgesic infusions, and being managed with the SLEAP sedation strategy
7. Patient recall of ICU events, measured on days 1 - 3, 1 month and 3 months post ICU discharge
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Sources of funding
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Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-85487)
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Trial website
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Publications
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Contact name
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Dr
Sangeeta
Mehta
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Address
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Mount Sinai Hospital
600 University Avenue, #18-216
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City/town
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Toronto, Ontario
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Zip/Postcode
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M5G 1X5
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Country
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Canada
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Tel
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+1 416 586 4800 ext. 4604
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Fax
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+1 416 586 8480
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Email
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geeta.mehta@utoronto.ca
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Sponsor
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Mount Sinai Hospital (Canada)
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Address
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600 University Avenue
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City/town
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Toronto, Ontario
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Zip/Postcode
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M5G 1X5
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Country
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Canada
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Sponsor website:
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http://www.mountsinai.on.ca/
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Date applied
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23/06/2008
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Last edited
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25/06/2008
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Date ISRCTN assigned
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23/06/2008
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