Preventing ventilator dependence in children through early management techniques
Application of Early Bundle Management of Mechanical Ventilation to Prevent Ventilator Dependence in Children
This study is testing a new treatment plan to see if early rehabilitation and nutrition can help children on ventilators avoid needing them for a long time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 28 Days to 18 Years |
| Sex | All |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06125210 on ClinicalTrials.gov |
What this trial studies
This study aims to develop a bundle treatment plan that includes early bedside rehabilitation, a nutrition program, and tracheotomy to prevent prolonged mechanical ventilation in children. By analyzing risk factors from previous studies, the researchers will implement these interventions at different time periods and compare outcomes with a control group. The goal is to reduce the incidence of ventilator dependence among stable children receiving mechanical ventilation.
Who should consider this trial
Good fit: Ideal candidates are stable children currently receiving mechanical ventilation without severe comorbidities.
Not a fit: Patients with conditions such as status epilepticus, active intracranial hemorrhage, or other severe injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the duration of mechanical ventilation and improve recovery outcomes for children.
How similar studies have performed: Previous studies have indicated that early intervention strategies can be effective in reducing ventilator dependence, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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: 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
Where this trial is running
Shanghai, Shanghai Municipality
- Children's hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.