Mechanical Ventilation Clinical Trial
Official title:
Daily Interruption of Sedative Infusions in Mechanically Ventilated Children: A Randomized Pilot Study
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
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