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

Prolonged Mechanical Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06125210
• Other study ID #: fdpicu-25
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: October 2026

Study information

• Verified date: November 2023
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Days to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Prolonged Mechanical Ventilation

Intervention

Behavioral:
• early bedside rehabilitation
? electrical diaphragm stimulation, ? electrical muscle stimulation, ? passive limb movement, ? 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

Locations

Country	Name	City	State
China	Children's hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	limb skeletal muscle function indexes	Skeletal muscle thickness and cross-sectional area were measured	21 days after enrollment