Daily sedative interruption in critically ill patients being managed with a sedation protocol
| ISRCTN | ISRCTN83837813 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83837813 |
| ClinicalTrials.gov (NCT) | NCT00675363 |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | MCT-85487; 07-0281-A; 08-0135-E |
| Sponsor | Mount Sinai Hospital (Canada) |
| Funders | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-85487), Canadian Intensive Care Foundation |
- Submission date
- 23/06/2008
- Registration date
- 23/06/2008
- Last edited
- 28/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Sangeeta Mehta
Scientific
Scientific
Mount Sinai Hospital
600 University Avenue, #18-216
Toronto, Ontario
M5G 1X5
Canada
| Phone | +1 (0)416 586 4800 ext. 4604 |
|---|---|
| geeta.mehta@utoronto.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Concealed unblinded randomised multicentre trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | SLEAP: a randomised trial of daily sedative interruption in critically ill, mechanically ventilated patients being managed with a sedation protocol |
| Study acronym | SLEAP |
| Study objectives | 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(s) | 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) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Time to successful extubation measured from intubation to extubation or tracheostomy mask for 48 hours. |
| Key secondary outcome measure(s) |
1. ICU and hospital mortality, patients will be followed until hospital discharge or death |
| Completion date | 01/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 504 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2008 |
| Date of final enrolment | 01/06/2010 |
Locations
Countries of recruitment
- Canada
- United States of America
Study participating centre
Mount Sinai Hospital
Toronto, Ontario
M5G 1X5
Canada
M5G 1X5
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 21/11/2012 | 28/02/2019 | Yes | No |
| Results article | results | 01/10/2015 | 28/02/2019 | Yes | No |
| Results article | results | 01/08/2016 | 28/02/2019 | Yes | No |
| Results article | results | 01/04/2015 | 28/02/2019 | Yes | No |
| Results article | results | 01/02/2016 | 28/02/2019 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
28/02/2019: Publication references added.
