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临床试验/NCT06125210
NCT06125210招募中不适用

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

Children's Hospital of Fudan University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
limb skeletal muscle function indexes

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
28 Days 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • (1)All stable children receiving mechanical ventilation
  • (1)Stable condition: respiratory rate does not exceed 20% of the basic respiratory rate, PEEP<
  • 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

排除标准

  • 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

研究组 & 干预措施

intervention group

Experimental

干预措施: early bedside rehabilitation (Behavioral)

intervention group

Experimental

干预措施: nutrition program (Dietary Supplement)

intervention group

Experimental

干预措施: tracheotomy (Procedure)

control group

No Intervention

结局指标

主要结局

limb skeletal muscle function indexes

时间窗: 21 days after enrollment

Skeletal muscle thickness and cross-sectional area were measured

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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