NCT00127621终止3 期
Early Tracheotomy Versus Prolonged Endotracheal Intubation in Intensive Care Unit Patients
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 468
- 试验地点
- 2
- 主要终点
- cumulated incidence of nosocomial pneumonia between days 1 and 28
研究概览
简要总结
This is a phase III trial comparing early tracheotomy versus prolonged endotracheal intubation in intensive care unit patients needing prolonged ventilatory support.
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
- •Patients under ventilation support for at least 4 days
- •Patients needing ventilatory support for > 7 days
- •Age > 18 years
- •Informed consent signed
排除标准
- •Patients previously tracheotomised
- •Major hemorrhagic risk
- •Patients previously randomised in a trial
结局指标
主要结局
cumulated incidence of nosocomial pneumonia between days 1 and 28
number of ventilatory free days between days 1 and 28
28 days mortality
次要结局
- number of septic episodes
- accidental extubation
- amount of sedation
- time in the ICU
- 60 days mortality
- time on mechanical ventilation
研究者
研究点 (2)
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