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

• Sponsor: Children's Hospital of Fudan University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06125210
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 37
• Patients Per Site Per Month: 4.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Prolonged Mechanical Ventilation	Behavioral: early bedside rehabilitation; Dietary Supplement: nutrition program; Procedure: tracheotomy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.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.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Application of Early Bundle Management of Mechanical Ventilation to Prevent Ventilator Dependence in Children
• Actual Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: Sep 1, 2026
• Anticipated Study Completion Date: Oct 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: intervention group	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
No Intervention: control group

Outcome Measures

Primary Outcome Measures

1. Respiratory and limb skeletal muscle function indexes on day 21 [21 days after enrollment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 28 Days to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

All stable children receiving mechanical ventilation 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's hospital of Fudan University	Shanghai	Shanghai	China

Sponsors and Collaborators

• Children's Hospital of Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Children's Hospital of Fudan University
• ClinicalTrials.gov Identifier: NCT06125210
• Other Study ID Numbers: fdpicu-25
• First Posted: Nov 9, 2023
• Last Update Posted: Nov 9, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 9, 2023