Neurally Adjusted Ventilatory Assist for Weaning From Invasive Mechanical Ventilation in Critically Ill Children

Not Applicable

Not yet recruiting

• Conditions: Mechanical Ventilation; Critically Ill; Neurally Adjusted Ventilatory Assist; Mechanical Ventilator Weaning
• Interventions: Procedure: NAVA

• Registration Number: NCT06157593
• Lead Sponsor: Chulalongkorn University

Brief Summary

The goal of this clinical trial is to compare weaning from mechanical ventilation in critically ill children. The main questions it aims to answer are:

* Will weaning with neurally adjusted ventilatory assist (NAVA) mode ventilation result in shorter ventilator day than synchronised intermittent mandatory ventilation (SIMV) mode?

* Will weaning with NAVA mode ventilation result in shorter paediatric intensive care unit (PICU) length of stay than SIMV mode? Participants will be randomised to NAVA or SIMV group for weaning from mechanical ventilation, then PICU outcomes from both groups will be collected, analysed and compared.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-24
• Study First Submitted QC: 2023-12-04
• Last Update Submitted: 2023-12-04
• Study First Posted: 2023-12-06
• Last Update Posted: 2023-12-06
• Study Start: 2024-02
• Primary Completion: 2025-02
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• all critically ill children admitted to PICU

Exclusion Criteria

• failure to obtain informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NAVA	NAVA	-

Primary Outcome Measures

Name	Time	Method
PICU length of stay	immediately after PICU discharge	number of days patients remain in PICU
ventilator day	immediately after extubation	number of days patients receive mechanical ventilation

Secondary Outcome Measures

Name	Time	Method
asynchrony index	20-minute period randomly captured from the day of extubation	asynchronous breaths divided by total breaths in 20 minutes

Trial Locations

Locations (1)

Chulalongkorn University; 🇹🇭 Bangkok, Thailand