Noninvasive Positive Pressure Ventilation in Moderate Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- all cause mortality
研究概览
简要总结
In order to identify the effect of noninvasive positive pressure ventilation (NPPV) on decreasing inflammatory response, improving the pathophysiological manifestation and reducing the morbidity and mortality in the moderate acute respiratory distress syndrome (ARDS) patients, the investigators conduct this clinical trial comparing NPPV with invasive mechanical ventilation in more than twenty ICUs in China.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute onset
- •a clinical presentation of respiratory distress
- •arterial oxygen tension/inspired oxygen fraction (PaO2/FiO2) between 200 mmHg to 300 mmHg. The arterial oxygen tension will be measured in fifteen minutes after NPPV (CPAP 5 cmH2O) was used to the patients stably
- •presence of bilateral pulmonary infiltrate on chest radiograph
- •no evidence of left heart failure as assessed by echocardiography and/or a pulmonary artery wedge pressure( PAWP) < 18 mmHg
排除标准
- •age > 70 years or < 18 years
- •PaCO2 > 50mmHg
- •Glasgow Coma Scale (GCS)< 11
- •Upper airway/facial deformity or injury
- •pneumothorax or pneumomediastinum
- •unable to spontaneously clear secretions from their airway
- •respiratory arrest
- •severe ventricular arrhythmia or active myocardial ischemia
- •severe organ dysfunction (including gastrointestinal hemorrhage, disseminated intravascular coagulation, hepatic and renal dysfunction, SOFA score > 1)
- •severe chronic lung diseases(COPD, Asthma or ILD, et al)
- •end-stage patients who are expected to survive less than six months
- •severe abdominal distension
- •refuse to receive NPPV
- •unable to cooperate with NPPV
研究组 & 干预措施
NPPV
Use the NPPV to treat moderate ARDS
干预措施: noninvasive positive pressure ventilation (NPPV) (Procedure)
IMV
Use invasive mechanical ventilation in treating the patients allocated to this group.
干预措施: invasive mechanical ventilation (Procedure)
结局指标
主要结局
all cause mortality
时间窗: From the date of randomization to the date of discharge from ICU and hospital, or to the date of death of all cause, an expected average of 28 days
次要结局
未报告次要终点
研究者
Chen Wang
Vice President
Beijing Hospital