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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Ottawa Hospital Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PS | Active Comparator | Nurse-directed protocols for administering sedation and/or analgesia by continuous infusion. |
|
| PS + DI | Active Comparator | Nurse-directed protocols for administering sedation and/or analgesia, with daily interruption of sedation/analgesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protocolized Sedation | Procedure | Nurse-directed protocol for administering sedation and/or analgesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| time to successful extubation | This will be the length of time that the patient remains on continuous infusions of sedation and/or analgesia in the ICU. At 60 days, all study interventions will terminate, but patients will be followed for outcomes. |
| Measure | Description | Time Frame |
|---|---|---|
| ICU and hospital lengths of stay, ICU and hospital mortality, Adverse events (e.g., self -removal of endotracheal tube) | This will be the length of time that the patient remains on continuous infusions of sedation and/or analgesia in the ICU. At 60 days, all study interventions will terminate, but patients will be followed for outcomes. |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Sangeeta Mehta, M.D. | MOUNT SINAI HOSPITAL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Long Beach Memorial Medical Center | Long Beach | California | United States | |||
| Tuft's Medical Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27480314 | Derived | Mehta S, Meade M, Burry L, Mallick R, Katsios C, Fergusson D, Dodek P, Burns K, Herridge M, Devlin JW, Tanios M, Fowler R, Jacka M, Skrobik Y, Olafson K, Cook D; SLEAP Investigators and the Canadian Critical Care Trials Group. Variation in diurnal sedation in mechanically ventilated patients who are managed with a sedation protocol alone or a sedation protocol and daily interruption. Crit Care. 2016 Aug 1;20(1):233. doi: 10.1186/s13054-016-1405-3. | |
| 26489482 |
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| Protocolized sedation, with daily interruption | Procedure | Nurse-directed protocols for administering sedation and/or analgesia, with daily interruption of sedation/analgesia |
|
| Boston |
| Massachusetts |
| United States |
| Royal Alexandra Hospital | Edmonton | Alberta | T5H 3V9 | Canada |
| Walter C. Mackenzie Health Sciences Centre | Edmonton | Alberta | T6G 2B7 | Canada |
| Royal Columbian Hospital | New Westminster | British Columbia | V3L 3W7 | Canada |
| Surrey Memorial Hospital | Vancouver | British Columbia | V3W 1Z2 | Canada |
| Providence Health Care-St. Paul's Hospital | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Winnipeg Health Sciences Centre | Winnipeg | Manitoba | R3A 1R9 | Canada |
| Hamilton Health Sciences | Hamilton | Ontario | L8L 2X2 | Canada |
| St. Joesph's Healthcare | Hamilton | Ontario | L8N 4A6 | Canada |
| Sunnybrook HSC | Toronto | Ontario | M4N 3M5 | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| Mount Sinai Hospital | Toronto | Ontario | M5G 1X5 | Canada |
| Toronto General Hospital | Toronto | Ontario | M5G 2N2 | Canada |
| Toronto Western Hospital | Toronto | Ontario | M5T 2S8 | Canada |
| Maisonneuve Rosemount | Montreal | Quebec | H1T 2M4 | Canada |
| Derived |
| Rose L, Burry L, Mallick R, Luk E, Cook D, Fergusson D, Dodek P, Burns K, Granton J, Ferguson N, Devlin JW, Steinberg M, Keenan S, Reynolds S, Tanios M, Fowler RA, Jacka M, Olafson K, Skrobik Y, Mehta S. Prevalence, risk factors, and outcomes associated with physical restraint use in mechanically ventilated adults. J Crit Care. 2016 Feb;31(1):31-5. doi: 10.1016/j.jcrc.2015.09.011. Epub 2015 Sep 25. |
| 26181221 | Derived | Burry L, Cook D, Herridge M, Devlin JW, Fergusson D, Meade M, Steinberg M, Skrobik Y, Olafson K, Burns K, Dodek P, Granton J, Ferguson N, Jacka M, Tanios M, Fowler R, Reynolds S, Keenan S, Mallick R, Mehta S; SLEAP Investigators; Canadian Critical Care Trials Group. Recall of ICU Stay in Patients Managed With a Sedation Protocol or a Sedation Protocol With Daily Interruption. Crit Care Med. 2015 Oct;43(10):2180-90. doi: 10.1097/CCM.0000000000001196. |
| 25466317 | Derived | Rose L, Fitzgerald E, Cook D, Kim S, Steinberg M, Devlin JW, Ashley BJ, Dodek P, Smith O, Poretta K, Lee Y, Burns K, Harvey J, Skrobik Y, Fergusson D, Meade M, Kraguljac A, Burry L, Mehta S; SLEAP Investigators; Canadian Critical Care Trials Group. Clinician perspectives on protocols designed to minimize sedation. J Crit Care. 2015 Apr;30(2):348-52. doi: 10.1016/j.jcrc.2014.10.021. Epub 2014 Oct 30. |
| 23180503 | Derived | Mehta S, Burry L, Cook D, Fergusson D, Steinberg M, Granton J, Herridge M, Ferguson N, Devlin J, Tanios M, Dodek P, Fowler R, Burns K, Jacka M, Olafson K, Skrobik Y, Hebert P, Sabri E, Meade M; SLEAP Investigators; Canadian Critical Care Trials Group. Daily sedation interruption in mechanically ventilated critically ill patients cared for with a sedation protocol: a randomized controlled trial. JAMA. 2012 Nov 21;308(19):1985-92. doi: 10.1001/jama.2012.13872. |
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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