Risk Factors of Difficult Intubation and Related Complications in Adults in Intensive Care Units(ICU)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,400
- 试验地点
- 2
- 主要终点
- Difficult intubation
研究概览
简要总结
Difficult intubation is challenging in intensive care units. There are limited data regarding risk factors of difficult intubation in ICU. The primary purpose of the investigators study is to assess the risk factors of difficult airway in adults in ICU.
详细描述
PURPOSE: Intubation in ICU strongly differs from intubation in operative rooms. The results of studies about risk factors of difficult intubation performed in operative rooms cannot therefore be extrapolated directly to ICU.
The primary purpose of this trial (cf Part "Design" of this registration) is "other" and more particularly "Prognosis" because it is is an assessment of risk factors of difficult airway in intensive care units.
DESIGN AND METHODOLOGY: This is an open prospective multicentric study of intubation in ICU in more than 50 centres. Consecutive intubations will be included in each centre, in order to reach the sample size required (at least 1000 procedures intubations). The usual risk factors of difficult intubation in operative rooms, the demographic parameters and the complications of intubation will be assessed, as well as survival status at 28 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •More or equal to 18 years old
- •Men and women
- •Informed patient
- •Affiliated or benefit from an disease insurance
- •Available for a 28 days follow-up
- •Intubated patients in Intensive Care Unit
排除标准
- •Law protected patients
- •Opposed to participate to study
研究组 & 干预措施
INTUBATION
Subjects intubed in Intensive Care Unit
干预措施: INTUBATION IN INTENSIVE CARE UNIT (Procedure)
结局指标
主要结局
Difficult intubation
时间窗: until to 10 minutes
According to ASA criteria, difficult intubation is measured by attempts lasting more than 10 min or more than two attempts
次要结局
- Complications of intubation in ICU(up to one hour after intubation)
- Mortality at 28 days after difficult intubation(up to 28 days after difficult intubation)
- Incidence of difficult intubation in ICU(up to day 28)