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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06125210
Enrollment
150
Registered
2023-11-09
Start date
2024-09-01
Completion date
2026-12-31
Last updated
2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prolonged Mechanical Ventilation

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

Interventions

BEHAVIORALearly bedside rehabilitation

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

DIETARY_SUPPLEMENTnutrition program

(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

PROCEDUREtracheotomy

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

Sponsors

Children's Hospital of Fudan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

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.

Eligibility

Sex/Gender
ALL
Age
28 Days to 18 Years
Healthy volunteers
No

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

1. Status epilepticus 2. Active intracranial hemorrhage 3. Intracranial hypertension 4. Unstable fracture of the spine 5. Spinal cord injury 6. There are injuries that affect the implementation of rehabilitation 7. Acute surgery was performed on the same day. 8. Body temperature over 40℃ 9. Brain function failure

Design outcomes

Primary

MeasureTime frameDescription
limb skeletal muscle function indexes21 days after enrollmentSkeletal muscle thickness and cross-sectional area were measured

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026