Comparison of Pre-oxygenation by Non-invasive Ventilation With High-flow Nasal Oxygen Therapy for Intubation of Intensive Care Patients in Cases of Acute Respiratory Failure: A Prospective, Randomized, Controlled Study (FLORALI 2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 30
- 主要终点
- Severe desaturation as defined by a pulse oxymetry below 80%
研究概览
简要总结
The aim of the study is to evaluate the incidence of severe hypoxemia episodes during the intubation procedure with two methods of pre-oxygenation:
- NIV (Non Invasive Ventilation)
- HFNC (High-flow nasal canula oxygen therapy)
详细描述
Design:
Clinical randomized, open, multicenter, comparative trial, with parallel groups aimed at evaluating a medical device.
Selection of patients admitted to the ICU for acute respiratory failure, requiring endotracheal intubation.
Randomized study, inclusion in two groups: NIV or HFNC.
Experimental group:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
NIV
NIV group, preoxygenation by NIV: pressure support set for an exhaled tidal volume of 6-8 ml / kg of ideal body weight, PEEP of 5 cm H2O and FiO2 at 100%.
干预措施: Noninvasive ventilation (Procedure)
HFNC
High-flow nasal canula oxygen therapy. NHFC group, preoxygenation by NHFC: oxygen flow rate of 60 L / min and 100% FiO2
干预措施: High Flow nasal canula oxygen therapy (Procedure)
结局指标
主要结局
Severe desaturation as defined by a pulse oxymetry below 80%
时间窗: through five minutes after preoxygenation period
drop below 80% of pulse oxymetry measurement
次要结局
未报告次要终点