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Sponsors and Collaborators: |
Mount Sinai Hospital, Canada Canadian Institutes of Health Research (CIHR) Ottawa Health Research Institute |
Information provided by: | Mount Sinai Hospital, Canada |
ClinicalTrials.gov Identifier: | NCT00675363 |
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.
Condition | Intervention |
Critical Illness |
Procedure: Protocolized Sedation Procedure: Protocolized sedation, with daily interruption |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Trial of Daily Sedative Interruption in Critically Ill, Mechanically Ventilated Patients Being Managed With a Sedation Protocol |
Estimated Enrollment: | 410 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | January 2011 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
PS: Active Comparator
Nurse-directed protocols for administering sedation and/or analgesia by continuous infusion.
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Procedure: Protocolized Sedation
Nurse-directed protocol for administering sedation and/or analgesia.
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PS + DI: Active Comparator
Nurse-directed protocols for administering sedation and/or analgesia, with daily interruption of sedation/analgesia
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Procedure: Protocolized sedation, with daily interruption
Nurse-directed protocols for administering sedation and/or analgesia, with daily interruption of sedation/analgesia
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria
Contact: Sangeeta Mehta, M.D. | 416-586-4800 ext 4604 | samehta@mtsinai.on.ca |
Contact: Marilyn Steinberg, R.N. | 416-586-4480 | MSteinberg@mtsinai.on.ca |
Canada, Alberta | |||||
Walter C. Mackenzie Health Sciences Centre | Not yet recruiting | ||||
Edmonton, Alberta, Canada, T6G 2B7 | |||||
Contact: Michael Jacka, M.D. | |||||
Principal Investigator: Michael Jacka, M.D. | |||||
Canada, British Columbia | |||||
Providence Health Care-St. Paul's Hospital | Not yet recruiting | ||||
Vancouver, British Columbia, Canada, V6Z 1Y6 | |||||
Contact: Peter Dodek, M.D. | |||||
Principal Investigator: Peter Dodek, M.D. | |||||
Canada, Ontario | |||||
Mount Sinai Hospital | Recruiting | ||||
Toronto, Ontario, Canada, M5G 1X5 | |||||
Contact: Sangeeta Mehta, M.D. 416-586-4800 ext 4604 samehta@mtsinai.on.ca | |||||
Contact: Marilyn Steinberg, R.N. 416-586-4480 MSteinberg@mtsinai.on.ca | |||||
Principal Investigator: Sangeeta Mehta, M.D. | |||||
Toronto Western Hospital | Not yet recruiting | ||||
Toronto, Ontario, Canada, M5T 2S8 | |||||
Contact: Niall Ferguson, M.D. | |||||
Principal Investigator: Niall Ferguson, M.D. | |||||
Toronto General Hospital | Not yet recruiting | ||||
Toronto, Ontario, Canada, M5G 2N2 | |||||
Contact: John Granton, M.D. | |||||
Principal Investigator: John Granton, M.D. | |||||
St. Michael's Hospital | Not yet recruiting | ||||
Toronto, Ontario, Canada, M5B 1W8 | |||||
Contact: Karen Burns, M.D. | |||||
Principal Investigator: Karen Burns, M.D. | |||||
Sunnybrook HSC | Not yet recruiting | ||||
Toronto, Ontario, Canada, M4N 3M5 | |||||
Contact: Rob Fowler, M.D. | |||||
Principal Investigator: Rob Fowler, M.D. | |||||
The Ottawa Hospital-General site | Not yet recruiting | ||||
Ottawa, Ontario, Canada, K1H 8L6 | |||||
Contact: Lauralyn McIntyre, M.D. | |||||
Principal Investigator: Lauralyn McIntyre, M.D. | |||||
Canada, Quebec | |||||
Maisonneuve Rosemount | Not yet recruiting | ||||
Montreal, Quebec, Canada, H1T 2M4 | |||||
Contact: Yaonna Skrobik, M.D. | |||||
Principal Investigator: Yoanna Skrobik, M.D. |
Mount Sinai Hospital, Canada |
Canadian Institutes of Health Research (CIHR) |
Ottawa Health Research Institute |
Principal Investigator: | Sangeeta Mehta, M.D. | MOUNT SINAI HOSPITAL |
Responsible Party: | Mount Sinai Hospital ( Dr. Sangeeta Mehta ) |
Study ID Numbers: | 85487 |
First Received: | May 7, 2008 |
Last Updated: | May 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00675363 |
Health Authority: | Canada: Health Canada; Canada: Canadian Institutes of Health Research |
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