Automatic Oxygen Supply With the O2matic Device for the Treatment of Hospitalized Heart Patients With Hypoxia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Time in designated saturation interval
研究概览
简要总结
Automatic oxygen supply with the O2matic device has been shown to provided an enhanced oxygen treatment in patients with hypoxemia. O2matic was significantly better than manual control to maintain oxygen saturation within target interval and to reduce time with unintended hypoxemia in patients suffering from chronic obstructive pulmonary disease. This trial investigates the effect of using O2matic in hypoxic patients submitted to the Department of Cardiology.
详细描述
Oxygen supply to patients with cardiovascular disease has been subject to several investigations. Both too much and too little oxygen is supposed to be harmful. The O2matic device is a new way of supplying oxygen treatment which is significantly better than manual control to maintain oxygen saturation within target interval and to reduce time with unintended hypoxemia. The device has past favorable tests in patients suffering from chronic obstructive pulmonary disease. This study investigates the application of the O2matic device on hypoxic patients admitted to the Cardiology ward.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with heart disease and an oxygen saturation below 94% admitted to the Department of Cardiology
- •Age of 30 or more
- •Intellectual capacity to participate in the trial
- •Willing to give informed accept of participation in the trial.
排除标准
- •Unstable patients
- •Need for ventilatory support except intermittent continuous positive airway pressure
- •Fertile women (age<55 years) with a positive pregnancy test
- •Unable to participate due to language or cognitive problems
结局指标
主要结局
Time in designated saturation interval
时间窗: 24 hours of treatment
We have predefined an optimum saturation interval of 92-96% with a target of 93%
次要结局
- Time with hypoxemia(24 hours of treatment)
- Time with hyperoxemia(24 hours of treatment)
- Time with severe hypoxemia(24 hours of treatment)
研究者
Jens D Hove, MD,PHD
Associate Professor, MD, PhD
Hvidovre University Hospital