Asymmetrical High Flow Oxygen Versus Noninvasive Ventilation in Acute Hypercapnic Respiratory Failure
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Power of Breathing
研究概览
简要总结
NIV is a life-saving treatment for people with breathing failure and carbon dioxide (CO2) retention. It helps remove this waste gas from the lungs and reduces the effort needed to breathe. However, the standard masks used for NIV can become uncomfortable over time, which may lead patients to stop using them. Stopping treatment can be dangerous and may cause breathing problems to worsen. That's why finding devices that are more comfortable and possibly more effective is very important. This study aims to take a first step in that direction.
This is the first study comparing new devices designed to help people with chronic CO2 buildup during breathing flare-ups. Devices tested include a new type of asymmetrical nasal cannula for high-flow oxygen therapy and a new mask called OptiNIV, which has a comfortable design that may help remove more CO2.
These devices will be compared to standard NIV masks currently used in hospitals. Outcome of interests include their effects on the effort needed to breathe, on how much CO2 is cleared, and on how comfortable they are.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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
- •Diagnosed with acute hypercapnic respiratory failure
- •Admitted to the intensive care unit
- •Being treated with either high-flow oxygen treatment or non-invasive ventilation
排除标准
- •Clinical instability - defined as the presence of one of the followings: respiratory rate > 40 breaths/minute, SpO2 < 80%, active broncho-pleural fistula, Glasgow Coma Scale < 8, mean arterial pressure below 60 mmHg despite usage of vasopressors
- •Requiring immediate need of endotracheal intubation, according to the judgement of the attending physician
- •Contraindications of monitoring with electrical impedance tomography (e.g. pacemaker, chest wall burns wounds limiting electrode placement).
研究组 & 干预措施
All study patient
Sequential respiratory support with 3 devices
干预措施: non-invasive ventilation with a new mask (Device)
All study patient
Sequential respiratory support with 3 devices
干预措施: asymmetrical high-flow nasal cannula (Device)
All study patient
Sequential respiratory support with 3 devices
干预措施: non-invasive ventilation with standard mask (Device)
结局指标
主要结局
Power of Breathing
时间窗: Minute 10, 20, and 30
A marker of the patient's work of breathing. Calculated by thickening fraction of the diaphragm, multiplied by the respiratory rate.
次要结局
- Ventilatory Ratio(Minute 10, 20, and 30)
- Patient's comfort(Minute 10, 20, and 30)
- Patient's subjective shortness of breath(Minute 10, 20, and 30)