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NCT06157593 Clinical Trial

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

Mechanical Ventilation Clinical Trial

Official title:
Neurally Adjusted Ventilatory Assist for Weaning From Invasive Mechanical Ventilation in Critically Ill Children: A Randomised Control Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06157593
Other study ID # 24112566
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 2024
Est. completion date July 2025

Study information
Verified date November 2023
Source Chulalongkorn University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date July 2025
Est. primary completion date February 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Month to 18 Years
Eligibility Inclusion Criteria: - all critically ill children admitted to PICU Exclusion Criteria: - failure to obtain informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• NAVA
weaning from mechanical ventilator using neurally adjusted ventilatory assist

Locations
Country Name City State
Thailand Chulalongkorn University Bangkok

Sponsors (1)
Lead Sponsor Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary ventilator day number of days patients receive mechanical ventilation immediately after extubation
Primary PICU length of stay number of days patients remain in PICU immediately after PICU discharge
Secondary asynchrony index asynchronous breaths divided by total breaths in 20 minutes 20-minute period randomly captured from the day of extubation
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