NCT01965821已完成不适用
Impact of Mallinckrodt Electronic Device on Continuous Control of Tracheal Cuff Pressure
University Hospital, Lille2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2013年10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 underinflations and overinflations frequently occur in critically ill patients, resulting in increased risk for microaspiration and tracheal ischemic lesions. The aim of this study is to determine the efficiency of Mallinckrodt electronic device (Mallinckrodt electronic cuff pressure controller, VBM Medizintechnik GmbH, Sulz aN) 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
- Treatment
- 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 high volume / low pressure PVC-cuffed tracheal tube
- •Predicted duration of mechanical ventilation > or = 48h
- •Age > or = 18 years
- •signed informed consent
排除标准
- •Contraindication for semirecumbent position
- •Contraindication for enteral nutrition
- •Pregnancy
- •refuse to participate to the study
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 2 24-h periods (with or without Mallinckrodt device)
次要结局
- Impact of Mallinckrodt electronic device on microaspiration of gastric contents, documented by pepsin levels in tracheal aspirates(48 hours)
研究者
研究点 (2)
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