Condition category
Surgery
Date applied
23/06/2008
Date assigned
23/06/2008
Last edited
25/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sangeeta Mehta

ORCID ID

Contact details

Mount Sinai Hospital
600 University Avenue
#18-216
Toronto
Ontario
M5G 1X5
Canada
+1 416 586 4800 ext. 4604
geeta.mehta@utoronto.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00675363

Protocol/serial number

MCT-85487; 07-0281-A; 08-0135-E

Study information

Scientific title

SLEAP: a randomised trial of daily sedative interruption in critically ill, mechanically ventilated patients being managed with a sedation protocol

Acronym

SLEAP

Study hypothesis

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.

The results of the pilot study to this trial can be found at: http://www.ncbi.nlm.nih.gov/pubmed/18552687

SLEAP-SCP Trial:
As of 25/02/2010 this record was updated to include details of an add-on trial entitled: 'SLEAP - Sleep, Cognition and Psychology (SLEAP-SCP): psychological, cognitive, and sleep morbidity associated with the use of a sedation protocol versus a sedation protocol and daily sedative interruption in critically ill, mechanically ventilated adults'. All details of this add-on trial can be found in the relevant fields with the subtitle 'SLEAP-SCP Trial'.

This proposed study will add psychosocial outcome measures to the existing SLEAP study in an attempt to determine if patients in either group have a superior psychological outcome.

The anticipated start and end dates of the SLEAP-SCP Trial are as follows:
Anticipated start date: 01/10/2009
Anticipated end date: 01/12/2011
The SLEAP-SCP Trial has a target number of participants of 94, and is recruiting in Canada, as well as the United States of America.

Ethics approval

Research Ethics Board of Mount Sinai Hospital (Toronto) approved on the 29th November 2007 (ref: 07-0281-A)

SLEAP-SCP Trial:
Research Ethics Board of Mount Sinai Hospital (Toronto) approved on the 8th July 2008 (ref: 08-0135-E)

Study design

Concealed, unblinded, randomised, multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Mechanical ventilation

Intervention

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.

SLEAP-SCP Trial:
Patients enrolled in SLEAP will be approached after ICU discharge for consent for SLEAP-SCP. At 1 week and 6 months post-ICU discharge, patients will undergo measurements of psychological variables, using validated instruments for the assessment of post-traumatic stress disorder (PTSD) symptomatology, delirium, neurocognitive impairment, anxiety, depression, sleep impairment, functional recovery following critical illness.

Sponsor details for the SLEAP-SCP Trial:
Canadian Intensive Care Foundation (Canada)
1537 - 9th Avenue S.E.
Calgary, AB, T2G 2N4
Canada
T: +1 403 262 2177
F: +1 403 261 6818
E: info@cicf.ca
Website: http://www.cicf.ca/English/Home/english%20home.html

Contact details for the SLEAP-SCP Trial:
Ms Marilyn Steinberg
Mt. Sinai Hospital
600 University Ave, Rm 18-210
Toronto, ON, M5G 1X5
Canada
T: +1 416 586 4800 ext. 7499
F: +1 416 586 8480
E: msteinberg@mtsinai.on.ca

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Time to successful extubation measured from intubation to extubation or tracheostomy mask for 48 hours.

SLEAP-SCP Trial:
Extent of depressive, anxiety (Hospital Anxiety And Depression Scale [HADS] scores) and PTSD symptoms (Impact of Events Scale [IES] scores), compared across the two arms of the SLEAP study.

Secondary outcome measures

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

Overall trial start date

01/01/2008

Overall trial end date

01/06/2010

Reason abandoned

Eligibility

Participant inclusion criteria

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

Additional SLEAP-SCP Trial inclusion criteria:
1. In an ICU at participating hospitals
2. Aged greater than or equal to 18 years old
3. Intubated and mechanically ventilated
4. Receiving infusions of sedation and/or analgesia
5. Able to speak and understand English

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

410 (+ 94 in SLEAP-SCP Trial)

Participant exclusion criteria

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

Additional SLEAP-SCP Trial exclusion criteria:
1. Patients unable to communicate
2. Incompetent to decide on participation

Recruitment start date

01/01/2008

Recruitment end date

01/06/2010

Locations

Countries of recruitment

Canada, United States of America

Trial participating centre

Mount Sinai Hospital
Toronto, Ontario
M5G 1X5
Canada

Sponsor information

Organisation

Mount Sinai Hospital (Canada)

Sponsor details

600 University Avenue
Toronto
Ontario
M5G 1X5
Canada

Sponsor type

Hospital/treatment centre

Website

http://www.mountsinai.on.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-85487)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

SLEAP-SCP Trial:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Additional funding for this add-on study comes from:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Canadian Intensive Care Foundation (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes