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

NCT06125210 | Recruiting DMC

• 1 other identifier: fdpicu-25
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Prolonged Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• limb skeletal muscle function indexes

  Skeletal muscle thickness and cross-sectional area were measured

  21 days after enrollment

Study Arms (2)

intervention group

EXPERIMENTAL

Behavioral: early bedside rehabilitation; Dietary Supplement: nutrition program; Procedure: tracheotomy

control group

NO INTERVENTION

Interventions

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

intervention group

tracheotomy PROCEDURE

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

intervention group

early bedside rehabilitation BEHAVIORAL

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

intervention group

Eligibility Criteria

• Age: 28 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• （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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's hospital of Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Interventions

Food Assistance; Tracheotomy

Intervention Hierarchy (Ancestors)

Public Assistance; Financing, Government; Financing, Organized; Economics; Health Care Economics and Organizations; Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention group: The bundle treatment plan was:1) After receiving mechanical ventilation for \<7 days, three of the following four items of intensive bedside rehabilitation were initiated: ① electrical diaphragm stimulation, ② electrical muscle stimulation, ③ passive limb movement, ④ respiratory rehabilitation. 2\) Receive mechanical ventilation \<14 days, start the target-oriented nutrition program, including: (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. 3\) Receiving mechanical ventilation \<21 days, tracheotomy transition to home mechanical ventilation (HMV), special diseases (central nervous system diseases) receiving mechanical ventilation 14-21 days recommended tracheotomy.

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 9, 2023
• Study Start: September 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)