NCT01617252已完成不适用
High Flow Nasal Oxygen Therapy for Hypoxemy After Cardiac Surgery
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Measure of PaO2/FiO2 ratio
研究概览
简要总结
The main objective of this study is to evaluate the gas exchange (ventilation-perfusion ratio) with the system Optiflow® compared to facial mask among patients having an acute respiratory failure after cardiac surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Patient with indication of coronary artery bypass
- •Absence of preoperative respiratory failure
- •Hypoxia after extubation defined as SpO2 < 96% with Venturi mask 50% 8L/min
- •Age > 18 years
- •Signed informed consent
排除标准
- •Patients requiring an imminent intubation, in coma or respiratory exhaustion, in a state of shock or severe rhythm disorders
- •Hemodynamic instability, low flow rate
- •Pneumothorax or hemothorax
- •Bleeding major, ischemic signs
- •Ventricular arrhythmia
- •Respiratory failure
- •Non controlled hyperalgia
- •Alteration of mental status
- •Cardiac surgery patients in post-operative valve surgery associated with coronary artery bypass surgery or isolated valve surgery
- •Pregnancy
- •Major under guardianship
研究组 & 干预措施
Optiflow
Experimental
干预措施: Optiflow / Facial mask (Device)
Facial mask
Experimental
干预措施: Optiflow / Facial mask (Device)
结局指标
主要结局
Measure of PaO2/FiO2 ratio
时间窗: One hour and 24 hours
The main objective of this study is to evaluate the gas exchange (ventilation-perfusion ratio) with the system Optiflow® compared to facial mask among patients having an acute respiratory failure after cardiac surgery.
次要结局
- Measure of pH, SatO2, PaO2, FiO2(2 days)
- Scale of satisfaction completed by the patient(at withdrawal of oxygen system)
- Measure of PCO2 and respiratory frequency(One day)
- Possibility of patient transfer in conventional service(at day 5)
- Number of days of hospitalization(at day 28)
研究者
研究点 (1)
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