Application of Early Bundle Management of Mechanical Vent... | NCT06125210

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

NCT06125210

Sponsor

Children's Hospital of Fudan University

Status

Recruiting

Last Update Posted

Feb 17, 2026Actual

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Prolonged Mechanical Ventilation

Interventions

early bedside rehabilitation
nutrition program
tracheotomy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2024Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Nov 6, 2023

First Submission Date that Met QC Criteria

Nov 6, 2023

First Posted Date

Nov 9, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2026

Last Update Posted Date

Feb 17, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intervention group	Experimental		Behavioral: early bedside rehabilitation Dietary Supplement: nutrition program Procedure: tracheotomy
control group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
early bedside rehabilitation	Behavioral	① electrical diaphragm stimulation, ② electrical muscle stimulation, ③ passive limb movement, ④ respiratory rehabilitation.	intervention group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
limb skeletal muscle function indexes	Skeletal muscle thickness and cross-sectional area were measured	21 days after enrollment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

28 Days

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's hospital of Fudan University	Recruiting	Shanghai	Shanghai Municipality		China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D063105	Food Assistance
D014140	Tracheotomy

Ancestor Terms

ID	Term
D011632	Public Assistance
D005380	Financing, Government
D005381	Financing, Organized
D004467	Economics

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

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.