NCT06157593

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 6, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

December 6, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

November 24, 2023

Last Update Submit

December 4, 2023

Conditions

Mechanical Ventilator WeaningCritically IllMechanical VentilationNeurally Adjusted Ventilatory Assist

Outcome Measures

Primary Outcomes (2)

  • ventilator day

    number of days patients receive mechanical ventilation

    immediately after extubation

  • PICU length of stay

    number of days patients remain in PICU

    immediately after PICU discharge

Secondary Outcomes (1)

  • asynchrony index

    20-minute period randomly captured from the day of extubation

Study Arms (2)

NAVA

EXPERIMENTAL
Procedure: NAVA

SIMV

NO INTERVENTION

Interventions

NAVAPROCEDURE

weaning from mechanical ventilator using neurally adjusted ventilatory assist

NAVA

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • all critically ill children admitted to PICU

You may not qualify if:

  • failure to obtain informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chulalongkorn University

Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2023

First Posted

December 6, 2023

Study Start

February 1, 2024

Primary Completion

February 1, 2025

Study Completion

July 1, 2025

Last Updated

December 6, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)