Effects of High-flow Oxygen Therapy and Non-invasive Ventilation on Lung Volumes and on Upper Airway in Hypoxemic Critical Care Patients: a Physiological Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Variation in poorly aerated lung volume
研究概览
简要总结
Respiratory failure is the most frequent organ failure and cause for admission in the Intensive Care Unit (ICU) . It is a severe complication with an ICU mortality ranged from 31% to 33%. Symptomatic treatment of hypoxemic respiratory failure is a controversial topic with different options: 1) standard oxygen therapy, 2) high flow nasal cannula oxygen therapy (HFNC) and 3) non-invasive ventilation (NIV).
The aim of the study is to compare HFNC versus NIV ventilation using CT scan. The hypothesis of this study is that in hypoxemic critically ill patients, the increase of lung volumes with NIV would be significantly higher than the increase of lung volumes with HFNC.
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
- 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
- •Patient with hypoxemia at any time of ICU stay defined as follow: standard oxygen therapy flow ≥ 3L/min to maintain a pulsed oxygen saturation ≥ 95%
- •Adult (age ≥ 18 years)
- •(2) A CT scan prescribed by the physician in charge of the patient as part of the exploration of the patient's pathology and not as part of a "dedicated" prescription for the study.
排除标准
- •NIV contraindication (need for immediate endotracheal intubation and mechanical ventilation; hemodynamic instability defined by systolic blood pressure < 90 mmHg or mean blood pressure < 65 mmHg, use of vasopressors; Glasgow Coma Scale score of 12 points or less)
- •History of recent facial trauma not compatible with the use of nasal cannulas
- •Pregnancy
- •Refusal of study participation
- •protected person
- •Patient not affiliated to the social security system or not benefiting from such a system
- •Lack of signed informed consent
结局指标
主要结局
Variation in poorly aerated lung volume
时间窗: the day of inclusion
The poorly aerated volume will be measured by CT scan
Variation in non-aereted lung volume
时间窗: the day of inclusion
The non-aereted volume will be measured by CT scan
次要结局
- Variation in cross-sectional upper airway area(the day of inclusion)
- Variation in Positive End Expiratory Pressure (PEEP)(the day of inclusion)
- Variation in Total lung volume(the day of inclusion)
- Variation in respiratory rate(the day of inclusion)
- Variation in normally aerated lung volume(the day of inclusion)
- Variation in cardiac output (Qc)(the day of inclusion)
- Variation in O2 gas exchange(the day of inclusion)
- Variation in CO2 gas exchange(the day of inclusion)
- Variation in patient comfort(the day of inclusion)