NCT02109003已完成不适用
Efficiency of PressureEasy in Controlling Tracheal Cuff Pressure in Intubated Critically Ill Patients
Corporacion Parc Tauli2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2014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
- 18
- 试验地点
- 2
- 主要终点
- Percentage of recording time spent with cuff overinflation or underinflation
研究概览
简要总结
Despite intermittent control of tracheal cuff pressure using a manual manometer, cuff underinflation and overinflation frequently occur in critically ill patients, resulting in increased risk for microaspiration and tracheal ischemic lesions.
详细描述
The aim of this study is to determine the efficiency of Pressure easy® device (Smiths medical cuff pressure controller) in continuous control of tracheal cuff pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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 intubated in the ICU with a polyvinyl chloride (PVC) cuffed tracheal tube.
- •Predicted duration of mechanical ventilation > or = 48h.
- •Age > or = 18 years.
- •Signed informed consent.
排除标准
- •Anticipated duration of mechanical ventilation<48h after randomization.
- •Tracheostomized patients.
- •Patients with contraindication for semirecumbent position.
- •Patients participating to another trial that might influence this study results.
结局指标
主要结局
Percentage of recording time spent with cuff overinflation or underinflation
时间窗: 48 hours
Continuous recording of cuff pressure will be performed during two 24-h periods (with or without Pressure easy® device)
次要结局
未报告次要终点
研究者
Antonio Artigas Raventós
Director of Critical Care Unit
Corporacion Parc Tauli
研究点 (2)
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