NCT04788589

Sedation and Ventilator Weaning Protocol in PICU

Effectiveness of Sedation and Ventilator Weaning Protocol - a Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: 1 Month – 17 Years
• Healthy volunteers: Not accepted

Summary

This research is a single-blinded, randomized controlled trial involving mechanically ventilated children in Pediatric Intensive Care Unit, Cipto Mangunkusumo Hospital, Indonesia. Subjects were divided into two groups: intervention vs control group. Primary and secondary outcomes will be measure pre, during, and post treatment.

Detailed description

As of today, there is no sedation and ventilator weaning protocol in our PICU. Decision for sedation and ventilator weaning were based on attending physicians clinical judgement, which greatly varies among individual. Previous study on the use of these protocols showed a favorable outcome. We aim to assess the safety and effectiveness of this protocol in our PICU. Subjects were recruited consecutively and randomized into intervention and control group. * Intervention group: sedation and ventilator weaning protocol * Control group: no protocol Primary outcomes: * FLACC score * COMFORT score * Ventilator days Secondary outcomes: * Self extubation * Reintubation * PICU Length of stay * Frequency of asynchrony * NIRS value * VIS score

Conditions

• Mechanical Ventilation
• Sedation

Interventions

Type	Name	Description
OTHER	Sedation and ventilator weaning protocol	Subjects randomized to this group will underwent sedation and ventilator weaning protocol as mentioned before.

Timeline

• Start date: 2020-09-01
• Primary completion: 2022-01-01
• Completion: 2022-07-01
• First posted: 2021-03-09
• Last updated: 2022-06-14

Locations

1 site across 1 country: Indonesia