NCT02426320

Pilot Study for Sedation Interruption in Children

Daily Interruption of Sedative Infusions in Mechanically Ventilated Children: A Randomized Pilot Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Davinia Withington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Daily Sedative Interruption
• Sedation Strategies
• Sedation Protocols
• Mechanical Ventilation
• Sedation

Interventions

Type	Name	Description
OTHER	Sedation Interruption Protocol
OTHER	Standard Sedation Protocol

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-04-01
• Completion: 2015-06-01
• First posted: 2015-04-24
• Last updated: 2015-04-24

Locations

1 site across 1 country: Canada