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

Fudan University logo

Fudan University

Status

Enrolling

Conditions

Prolonged Mechanical Ventilation

Treatments

Procedure: tracheotomy
Dietary Supplement: nutrition program
Behavioral: early bedside rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT06125210
fdpicu-25

Details and patient eligibility

About

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

Enrollment

150 estimated patients

Sex

All

Ages

28 days to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

150 participants in 2 patient groups

intervention group
Experimental group
Treatment:
Behavioral: early bedside rehabilitation
Dietary Supplement: nutrition program
Procedure: tracheotomy
control group
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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