NCT01166256Unknown2 期
Prospective, Open-labeled, Randomized Controlled Trial of Comparison Between High-flow Nasal Cannula System and Non-invasive Ventilation in Acute Hypoxemic Respiratory Failure
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Success rate of treatment in two groups
研究概览
简要总结
Acute hypoxemic respiratory failure may require invasive mechanical ventilation. However, invasive mechanical ventilation is associated with a variety of complications. Non-invasive ventilation has been presented as an alternative treatment but controversy remains. The investigators hypothesize that high-flow nasal cannula system is effective enough to prevent intubation in acute hypoxemic respiratory failure and not inferior to non-invasive ventilation.
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
- •Age above 18
- •patients with acute hypoxemic respiratory failure
排除标准
- •age < 18 years
- •hypercapnia (arterial carbon dioxide tension (PaCO2) >45mmHg) at admission
- •need for emergency intubation, including cardiopulmonary resuscitation
- •recent esophageal, facial or cranial trauma or surgery
- •severely decreased consciousness (Glasgow coma score <11)
- •cardiogenic shock or severe hemodynamic instability
- •systolic blood pressure <90 mmHg associated with decreased urinary output(<20 mL.h-1) despite fluid repletion and use of vasoactive agents
- •lack of co-operation
- •altered mental status with decreased consciousness and/or evidence of inability to understand or lack of willingness to co-operate with the procedures
- •tracheotomy or other upper airway disorders
- •severe ventricular arrhythmia or active myocardial ischemia
- •active upper gastrointestinal bleeding
- •inability to clear respiratory secretions
- •more than one severe organ dysfunction in addition to respiratory failure
结局指标
主要结局
Success rate of treatment in two groups
时间窗: up to 28 days
Successful treatment is to avoid intubation and achieve PaO2 \>75 mmHg without respiratory distress for 24 hours while spontaneously breathing oxygen provided by a Venturi device at FiO2 0.50.
次要结局
- compliance of treatment(up to 28 days)
- adverse event(up to 28 days)
- hospital length of stay(up to 90 days)
- Hospital mortality(up to 90 days)
研究者
研究点 (1)
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