Actively Recruiting

Phase Not Applicable
Age: 28Days - 18Years
All Genders
NCT06125210

Application of Early Bundle Management of Mechanical Ventilation to Prevent Ventilator Dependence in Children

Led by Children's Hospital of Fudan University · Updated on 2026-02-17

150

Participants Needed

1

Research Sites

121 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is based on the risk factors of previous studies to formulate a bundle treatment plan to prevent ventilator dependence in children, in order to reduce the proportion of ventilator dependence in children and provide a theoretical basis for reasonable intervention of children with mechanical ventilation. Participants will receive intensive rehabilitation, nutrition, and tracheotomy at different time periods. Researchers will compare the control group to see whether it can reduce the incidence of ventilator dependence

CONDITIONS

Official Title

Application of Early Bundle Management of Mechanical Ventilation to Prevent Ventilator Dependence in Children

Who Can Participate

Age: 28Days - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Stable children receiving mechanical ventilation
  • Respiratory rate does not exceed 20% above baseline
  • Positive end-expiratory pressure (PEEP) less than 8
  • VIS score less than 20
  • No hypotension (70 mmHg + age × 2; 70 mmHg if under 1 year old)
  • No body temperature over 40°C
  • Vital signs not exceeding 95th percentile for age and sex
Not Eligible

You will not qualify if you...

  • Status epilepticus
  • Active intracranial hemorrhage
  • Intracranial hypertension
  • Unstable fracture of the spine
  • Spinal cord injury
  • Injuries affecting rehabilitation
  • Acute surgery performed on the same day
  • Brain function failure

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Children's hospital of Fudan University

Shanghai, Shanghai Municipality, China

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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