NCT01320384已完成2 期
Clinical Effect of the Association of Noninvasive Ventilation and High Flow Nasal Oxygen Therapy in Resuscitation of Patients With Acute Lung Injury. A Randomised Study (FLORALI Study)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 313
- 试验地点
- 1
- 主要终点
- To compare the number of patients in each group who require endotracheal intubation with mechanical ventilation
研究概览
简要总结
The aim of the study is to compare, in patients with acute respiratory failure/acute lung injury the efficacy of three different methods of oxygenation to prevent endotracheal intubation :
- conventional oxygen therapy (O2 conventional)
- high flow nasal oxygen therapy (O2-HFN)
- association of high flow nasal oxygen therapy with non invasive positive pressure ventilation (O2-HFN/NPPV).
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hypoxemic and no hypercapnic acute respiratory failure :
- •severe dyspnea at rest with a respiratory rate >25 breaths/min
- •PaO2/FiO2 <300
- •PaCO2 <45 mmHg,
排除标准
- •age <18 years
- •NPPV contraindications
- •past history of respiratory chronic disease (COPD, cystic fibrosis...)
- •cardiac pulmonary edema
- •Pre-defined intubation
- •other than respiratory organ failure : systolic pressure <90 mmHg,current treatment with epinephrine or norepinephrine, decreased level of consciousness ( Glasgow score ≤ 12)
- •profound aplasia (white cells count <1000/mm 3)
研究组 & 干预措施
O2 conventional : standard low flow therapy
Active Comparator
in order to obtain a SpO2>92%
干预措施: O2 conventional (Other)
O2-HNF : high flow nasal oxygen therapy
Experimental
set between 30 to 50 l/min,adjusted in order to obtain a SpO2 >92%.
干预措施: O2-HFN : high flow nasal oxygen therapy (Device)
O2-HFN/NPPV
Experimental
cycling of NIV and O2-HDN
干预措施: O2-HFN/NPPV : association of high flow nasal oxygen therapy and non invasive positive pressure ventilation (Device)
结局指标
主要结局
To compare the number of patients in each group who require endotracheal intubation with mechanical ventilation
时间窗: at day 28
次要结局
- mechanical ventilation-free to day 28(28 days)
- ICU morbidity(at day 28)
研究者
研究点 (1)
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