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Clinical Trial 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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04788589
Study type Interventional
Source Indonesia University
Contact
Status Active, not recruiting
Phase N/A
Start date September 1, 2020
Completion date July 1, 2022

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