Application of Early Bundle Management of Mechanical Ventilation to Prevent Ventilator Dependence in Children
NCT ID: NCT06125210
Last Updated: 2025-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2023-09-01
2026-10-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
PREVENTION
QUADRUPLE
Study Groups
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intervention group
early bedside rehabilitation
① electrical diaphragm stimulation, ② electrical muscle stimulation, ③ passive limb movement, ④ respiratory rehabilitation.
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
tracheotomy
early tracheotomy for special diseases (e.g central nervous system diseases) receiving mechanical ventilation 14-21 days recommended tracheotomy
control group
No interventions assigned to this group
Interventions
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early bedside rehabilitation
① electrical diaphragm stimulation, ② electrical muscle stimulation, ③ passive limb movement, ④ respiratory rehabilitation.
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
tracheotomy
early tracheotomy for special diseases (e.g central nervous system diseases) receiving mechanical ventilation 14-21 days recommended tracheotomy
Eligibility Criteria
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Inclusion Criteria
（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
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
28 Days
18 Years
ALL
No
Sponsors
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Children's Hospital of Fudan University
OTHER
Responsible Party
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Locations
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Children's hospital of Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Facility Contacts
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Other Identifiers
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fdpicu-25
Identifier Type: -
Identifier Source: org_study_id
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