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NCT Number: NCT06125210

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

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

Recruiting

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Key information

Conditions

Prolonged Mechanical Ventilation

Age range

28 day–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's hospital of Fudan University

Shanghai, Shanghai Municipality, China

Location status: Recruiting

Location contact

Zhengzheng Zhang, doctor

CONTACT

[email protected]

+86 18121445817

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

（1）All stable children receiving mechanical ventilation

（1）Stable condition: respiratory rate does not exceed 20% of the basic respiratory rate, PEEP< 8. 60%, VIS score< 20, there is no hypotension (70mmHg+ age ×2, 70mmHg under one year old), no higher than the P95 of the same sex and age

Exclusion criteria

  • Status epilepticus
  • Active intracranial hemorrhage
  • Intracranial hypertension
  • Unstable fracture of the spine
  • Spinal cord injury
  • There are injuries that affect the implementation of rehabilitation
  • Acute surgery was performed on the same day.
  • Body temperature over 40℃
  • Brain function failure

Treatment and study plan

early bedside rehabilitation

Behavioral

① electrical diaphragm stimulation, ② electrical muscle stimulation, ③ passive limb movement, ④ respiratory rehabilitation.

Nutrition Program

Dietary Supplement

(1) nutrition department consultation, (2) MDT to develop individualized nutritional pathways, nutrient formulations and use methods, and achieve the target nutritional level within 2 weeks

Tracheotomy

Procedure

early tracheotomy for special diseases (e.g central nervous system diseases) receiving mechanical ventilation 14-21 days recommended tracheotomy

Primary outcomes

  1. limb skeletal muscle function indexes

    Time frame: 21 days after enrollment

    Skeletal muscle thickness and cross-sectional area were measured

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 9, 2023
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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