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
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 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
- 否
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
研究组 & 干预措施
Assisted strategy
Experimental
Ability to be weaned is determined with pressure support and positive end-expiratory pressure.
干预措施: Assisted strategy (Procedure)
Non assisted strategy
Active Comparator
Ability to be weaned is determined with T-piece.
干预措施: Non assisted strategy (Procedure)
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
- ventilator-free days at Day 90(90 days)
- Day 90 mortality(90 days)
- reintubation rate(90 days)
- Rate of first extubation(90 days)
- duration of non-invasive and invasive mechanical ventilation(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
研究点 (1)
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