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临床试验/NCT03861117
NCT03861117已完成不适用

Impact of the Combination of Pressure Support and Positive End Expiratory Pressure During Spontaneous Breathing Trial Versus T-piece on the Time to Successful Extubation

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2019年5月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
98
试验地点
2
主要终点
Time (hours) to successful extubation

研究概览

简要总结

The aim of this study is to assess if a bundle associating pressure support and positive end-expiratory pressure during spontaneous breathing trial and detection by T-piece of patients with high-risk of extubation failure can reduce the time to successful extubation in critically ill patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient 18 years old or more
  • Intubated and ventilated in intensive care unit for more than 24 hours
  • Patient ready for weaning evaluation
  • Failure of a first T-piece SBT

排除标准

  • Chronic neuromuscular disease
  • Guillain-Barré Syndrome
  • Central nervous system disease with consciousness disorder
  • Tracheostomy
  • Chronic disease with life expectancy less than 1 year
  • Pregnancy, breast feeding
  • Withholding life support regarding a reintubation
  • Prisoner or patient interned in psychiatric hospital
  • Guardianship
  • Language barrier
  • Lack of medical insurance
  • Lack of the patient's consent (or of the next of kin where appropriate)
  • Patient under an exclusion period after enrollment in another research study

结局指标

主要结局

Time (hours) to successful extubation

时间窗: 90 days

Successful extubation is defined as extubation without retintubation within the 7 following days.

次要结局

  • reintubation rate(90 days)
  • ventilator-free days at Day 90(90 days)
  • Rate of first extubation(90 days)
  • duration of non-invasive and invasive mechanical ventilation(90 days)
  • Day 90 mortality(90 days)
  • Intensive care unit length of stay(90 days)
  • Invasive mechanical ventilation duration(90 days)
  • hospital length of stay(90 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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