NCT01188122已完成不适用
Optimal Endotracheal Cuff Pressure During Hospitalization in Intensive Care Units Using AnapnoGuard 100 System
Hospitech Respiration1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2008年4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
- 12
- 试验地点
- 1
- 主要终点
- Recording the changes in optimal ETT cuff pressure and their effectors during the course of mechanical ventilation and intubation in Intensive Care Unit (ICU).
研究概览
简要总结
Hospitech Respiration Ltd has developed the AnapnoGuard system, an innovative system intended to enhance optimal endotracheal tube (ETT) cuff inflation, by monitoring carbon dioxide (CO2) in upper airways of mechanically ventilated patients. Optimal ETT cuff inflation will lead to a reduction of complication rate related to mechanical ventilation procedure.
This study was design in order to evaluate the feasibility of using the AnapnoGuard system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Age above 18 (men and woman);
- •Patient is admitted to ICU and expected to receive mechanical ventilation for at least 48 hours;
- •Normal chest X-ray;
- •Connection of the ETT to the AnapnoGuard system less than 6 hours from intubation initiation;
- •Signed informed consent by subject's legally acceptable representative.
排除标准
- •Patients who had been treated with mechanical ventilation during the last year;
- •Fever from known chest/lung origin;
- •Patients with facial, oropharyngeal or neck trauma;
- •Height < 1.6 m;
- •Any chest X-ray pathology during the first 24 hours post intubation;
- •More than 7 days hospitalization prior to the intubation. Chest/lung infection.
结局指标
主要结局
Recording the changes in optimal ETT cuff pressure and their effectors during the course of mechanical ventilation and intubation in Intensive Care Unit (ICU).
时间窗: during intubation (2-14 days)
次要结局
- Adverse events occurrence(During intubation (2-14 days))
研究者
研究点 (1)
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