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

NCT ID: NCT06157593

Last Updated: 2023-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-29

Study Completion Date

2025-07-31

Brief Summary

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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

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Conditions

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Mechanical Ventilator Weaning Critically Ill Mechanical Ventilation Neurally Adjusted Ventilatory Assist

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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NAVA

Group Type EXPERIMENTAL

NAVA

Intervention Type PROCEDURE

weaning from mechanical ventilator using neurally adjusted ventilatory assist

SIMV

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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NAVA

weaning from mechanical ventilator using neurally adjusted ventilatory assist

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* all critically ill children admitted to PICU

Exclusion Criteria

* failure to obtain informed consent
Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chulalongkorn University

Bangkok, , Thailand

Site Status

Countries

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Thailand

Facility Contacts

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Sirawut Trepatchayakorn

Role: primary

Other Identifiers

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24112566

Identifier Type: -

Identifier Source: org_study_id