Pilot Study for Sedation Interruption in Children
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|ClinicalTrials.gov Identifier: NCT02426320|
Recruitment Status : Unknown
Verified April 2015 by Davinia Withington, McGill University Health Centre/Research Institute of the McGill University Health Centre.
Recruitment status was: Recruiting
First Posted : April 24, 2015
Last Update Posted : April 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Daily Sedative Interruption Sedation Strategies Sedation Protocols Mechanical Ventilation Sedation||Other: Sedation Interruption Protocol Other: Standard Sedation Protocol||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Daily Interruption of Sedative Infusions in Mechanically Ventilated Children: A Randomized Pilot Study|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||April 2015|
|Estimated Study Completion Date :||June 2015|
Active Comparator: Sedation Interruption Protocol + standard sedation protocol
Nurse directed protocols for administering sedation and/or analgesia, with daily interruption of sedation/analgesia
Other: Sedation Interruption Protocol
Active Comparator: Standard sedation protocol
Nurse directed protocol for administering sedation and/or analgesia.
Other: Standard Sedation Protocol
- Recruitment rate [ Time Frame: At 30 days ]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.
- Adherence Rate [ Time Frame: At 30 days ]
- Reasons for non-participation [ Time Frame: At 30 days ]
- Duration of mechanical ventilation in hours. [ Time Frame: intraoperative ]Total number of hours between the moment patient was intubated to the moment of extubation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02426320
|Contact: Yasser Kazzaz, MBBS, FRCPC, FAAPfirstname.lastname@example.org|
|Contact: Davinia Withington, BM FRCA MRCPemail@example.com|
|Montreal Children's Hospital||Recruiting|
|Montreal, Quebec, Canada, H3H 1P3|
|Principal Investigator:||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|
|Principal Investigator:||Maryse Dagenais||McGill University Health Centre/Research Institute of the McGill University Health Centre|