Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2015-04-30
2015-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Sedation Interruption Protocol + standard sedation protocol
Nurse directed protocols for administering sedation and/or analgesia, with daily interruption of sedation/analgesia
Sedation Interruption Protocol
Standard sedation protocol
Nurse directed protocol for administering sedation and/or analgesia.
Standard Sedation Protocol
Interventions
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Sedation Interruption Protocol
Standard Sedation Protocol
Eligibility Criteria
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Inclusion Criteria
* Sedation managed by benzodiazepines and opioids infusions
Exclusion Criteria
* Trauma \& burn admissions
* Patients resuscitated from cardiac arrest
* Allergy to sedation (midazolam)
* Allergy to analgesia (fentanyl, morphine)
* Difficult airway including post-operative airway surgeries. (As deemed by ICU physician in charge)
* High frequency oscillator
* Special gas as inhaled nitric oxide, or isoflurane.
* Chronic ventilatory support
* Neuromuscular diseases
* Corrected Gestational age less than 37 weeks.
* Patients not expected to survive to discharge as per attending physician.
* Palliative care patients.
18 Years
ALL
No
Sponsors
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Davinia Withington
OTHER
Responsible Party
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Davinia Withington
Pediatric Anesthesiologist and Intensivist
Principal Investigators
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Conall Francoeur
Role: PRINCIPAL_INVESTIGATOR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Christina Maratta
Role: PRINCIPAL_INVESTIGATOR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Maryse Dagenais
Role: PRINCIPAL_INVESTIGATOR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Locations
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Montreal Children's Hospital
Montreal, Quebec, Canada
Countries
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Central Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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14-011-PED
Identifier Type: -
Identifier Source: org_study_id
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