High Flow Nasal Oxygen Versus VNI for Emergency Department Treatment of Acute Hypercapnic Cardiogenic Pulmonary Edema With Respiratory Failure: a Multicenter Randomized Non Inferiority Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Proportion of patients with a normalized PaCO2
研究概览
简要总结
The purpose of this study is to determine whether high flow nasal oxygen (HFNO) therapy is non inferior to non invasive ventilation (NIV) in the immediate treatment of patients with acute hypercapnic cardiogenic pulmonary edema associated with respiratory failure in the emergency department.
详细描述
Prospective multicenter study including ED patients with a suspected diagnosis of acute hypercapnic pulmonary edema with respiratory failure who require NIV according to the joint recommendations from the French society of anaesthesia and intensive care and the French society for intensive care.
Patients will be randomly assigned to NIV or high flow nasal oxygen therapy, with stratification on center and severity of hypercania.
Assigned Treatment will be administered during at least one session of 1hr and resumed as needed based on the patient's signs of respiratory distress and blood gas results Repeat evaluation of arterial blood gases, clinical parameters and dyspnea will be performed before and after the first and second hour of treatment according to current recommendation from the French society of anesthesia and intensive care medicine (SFAR).
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
Optiflow Group
High flow nasal oxygen therapy
干预措施: High flow nasal oxygen therapy (Device)
NIV group
干预措施: Non invasive ventilation (Device)
结局指标
主要结局
Proportion of patients with a normalized PaCO2
时间窗: 1hr of treatment
(PaCO2 equal or lower than 45 mmHg)
次要结局
- Mortality(7 day and 1 month follow up)
- Patient's dypnea(End of management (before discharge from ER))
- Patient's comfort(End of management (before discharge from ER))
- Endotracheal intubation(7 day and 1 month follow up)
- Blood gas parameters(End of management (before discharge from ER))