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The purpose of this study is to estimate the hypothesized benefit of sedation interruption protocol on mechanical ventilation duration and PICU length of stay. The study will evaluate recruitment rates, and adherence rates of such protocol.
This is a prospective single-center, superiority, open randomized controlled trial comparing sedation interruption protocol and routine continuous sedation in mechanically ventilation (MV) children.
The study will be conducted in the twelve beds Pediatric Intensive Care Unit (PICU) at the Montreal Children's Hospital, a pediatric tertiary care and teaching hospital.
Patients will be enrolled prospectively within 24 hours of intubation and MV. After obtaining written consent patients will then be randomized to interrupted sedation or standard sedation protocol. The investigators will randomize using a computer-generated sequence of random numbers.
A Sedation protocol will be used for both groups to adjust continuous infusions of sedatives/analgesics to a targeted Comfort-Behavior scale. In the intervention group, sedation infusions will be interrupted daily at 8:00 AM, this interruption will be continued until the patient is under-sedated according to the Comfort Behavior scale goals or in the presence of symptoms of hemodynamic instability or respiratory distress. Then the patient will receive a bolus of sedation and the infusion will be restarted at a dose 50% less than the previous dose to return to the Comfort Score goal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sedation Interruption Protocol + standard sedation protocol | Active Comparator | Nurse directed protocols for administering sedation and/or analgesia, with daily interruption of sedation/analgesia |
|
| Standard sedation protocol | Active Comparator | Nurse directed protocol for administering sedation and/or analgesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sedation Interruption Protocol | Other |
| ||
| Standard Sedation Protocol |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | The number of eligible patients who provided informed consent to participate in the study divided by the total number of eligible patients who were asked for informed consent during the pilot study period over 1 year period. | At 30 days |
| Adherence Rate | At 30 days | |
| Reasons for non-participation | At 30 days | |
| Duration of mechanical ventilation in hours. | Total number of hours between the moment patient was intubated to the moment of extubation. | intraoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yasser Kazzaz, MBBS, FRCPC, FAAP | Contact | 6479892770 | yasser.md@gmail.com | |
| Davinia Withington, BM FRCA MRCP | Contact | davinia.withington@mcgill.ca |
| Name | Affiliation | Role |
|---|---|---|
| Conall Francoeur | McGill University Health Centre/Research Institute of the McGill University Health Centre | Principal Investigator |
| Christina Maratta | McGill University Health Centre/Research Institute of the McGill University Health Centre |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal Children's Hospital | Recruiting | Montreal | Quebec | H3H 1P3 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10816184 | Background | Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000 May 18;342(20):1471-7. doi: 10.1056/NEJM200005183422002. | |
| 15187505 | Background | Schweickert WD, Gehlbach BK, Pohlman AS, Hall JB, Kress JP. Daily interruption of sedative infusions and complications of critical illness in mechanically ventilated patients. Crit Care Med. 2004 Jun;32(6):1272-6. doi: 10.1097/01.ccm.0000127263.54807.79. |
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| Other |
|
| Maryse Dagenais | McGill University Health Centre/Research Institute of the McGill University Health Centre | Principal Investigator |
| 18191684 | Background | Girard TD, Kress JP, Fuchs BD, Thomason JW, Schweickert WD, Pun BT, Taichman DB, Dunn JG, Pohlman AS, Kinniry PA, Jackson JC, Canonico AE, Light RW, Shintani AK, Thompson JL, Gordon SM, Hall JB, Dittus RS, Bernard GR, Ely EW. Efficacy and safety of a paired sedation and ventilator weaning protocol for mechanically ventilated patients in intensive care (Awakening and Breathing Controlled trial): a randomised controlled trial. Lancet. 2008 Jan 12;371(9607):126-34. doi: 10.1016/S0140-6736(08)60105-1. |
| 19399980 | Background | Anifantaki S, Prinianakis G, Vitsaksaki E, Katsouli V, Mari S, Symianakis A, Tassouli G, Tsaka E, Georgopoulos D. Daily interruption of sedative infusions in an adult medical-surgical intensive care unit: randomized controlled trial. J Adv Nurs. 2009 May;65(5):1054-60. doi: 10.1111/j.1365-2648.2009.04967.x. |
| 23180503 | Background | 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. |
| 21283046 | Background | Gupta K, Gupta VK, Jayashree M, Singhi S. Randomized controlled trial of interrupted versus continuous sedative infusions in ventilated children. Pediatr Crit Care Med. 2012 Mar;13(2):131-5. doi: 10.1097/PCC.0b013e31820aba48. |