Application of Early Bundle Management of Mechanical Ventilation to Prevent Ventilator Dependence in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: early bedside rehabilitation, nutrition program, tracheotomy.
- Who it may be relevant to
- Registry conditions: Prolonged Mechanical Ventilation. Basic parameters: 28 Days — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Behavioral early bedside rehabilitation
① electrical diaphragm stimulation, ② electrical muscle stimulation, ③ passive limb movement, ④ respiratory rehabilitation. - Dietary supplement nutrition 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 - Procedure tracheotomy
early tracheotomy for special diseases (e.g central nervous system diseases) receiving mechanical ventilation 14-21 days recommended tracheotomy
Primary outcome measures
- limb skeletal muscle function indexes [Time frame: 21 days after enrollment]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Children's hospital of Fudan University — Shanghai
Identifiers
NCT: NCT06125210 · fdpicu-25