NCT01550978已完成不适用
The Safety of Using the AnapnoGuard 100 System in Intubated Critical Care Patients
Hospitech Respiration1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Rate of AE (adverse events) and SAE (serious adverse events)
研究概览
简要总结
The purpose of this study is to evaluate the safety of using the AnapnoGuard 100 system during the course of mechanical ventilation and intubation of critical care patients in Intensive Care Unit.
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
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age above 21 (men and women);
- •Patient is admitted to ICU and expected to receive mechanical ventilation for more than 12 hours
- •Absence of clear signs of pneumonia and lung contusion on chest X ray;
- •For study patients, connection of the ETT to the AnapnoGuard system less than 6 hours from intubation initiation;
- •No fever or fever from a known non chest/lung origin;
排除标准
- •Patients who had been treated with mechanical ventilation during the last 3 months;
- •Patients with facial, oropharyngeal or neck trauma
- •BMI > 40
- •Pregnant women
- •Patients ventilated in prone position
- •Difficult intubation (defined as more than 3 intubation attempts)
结局指标
主要结局
Rate of AE (adverse events) and SAE (serious adverse events)
时间窗: participants will be followed for the entire duration of intubation (an expected average of 8 days)
次要结局
未报告次要终点
研究者
研究点 (1)
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