Evaluation of the Safety and Efficacy of CAM (Complete Airway Management) Catheters: Phase II Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- work of breathing
研究概览
简要总结
The purpose of this study is to measure secretion accumulation within endotracheal tubes of mechanically ventilated patients and test the efficacy, safety and clinical impact of removing the secretions using novel airway management catheters (Complete Airway Management Catheters: CAM Rescue Cath and CAM Endotrach Cath).
详细描述
Thirty mechanically ventilated adult patients will be managed with standard suction catheters. Just prior to extubation, their physiological parameters (including work of breathing) will be recorded and acoustic reflectometry used to measure the degree of secretion accumulation within the endotracheal tube. The endotracheal tubes will then be cleaned using the CAM Catheters (Rescue Cath followed by Endotrach Cath) and the physiological parameters and endotracheal tube reflectometry measurements repeated for comparative analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients receiving medical care in adult intensive care unit setting
- •Patients who have been intubated and mechanically ventilated for at least 12 hours
- •Patients intubated with an endotracheal tube with an internal diameter of 7.0 mm or greater
排除标准
- •Patients receiving medical care in a setting not compatible with an adult intensive care unit
- •Patients who have been intubated and mechanically ventilated for less than 12 hours
- •Patients intubated with an endotracheal tube with an internal diameter of 6.5 mm or less
- •Patients intubated with dual lumen or steel-reinforced endotracheal tubes
结局指标
主要结局
work of breathing
时间窗: pre-extubation
次要结局
- endotracheal tube patency(pre-extubation)