NCT01581229已完成不适用
Early Use of Noninvasive Positive Pressure Ventilation for Intro-pulmonary Acute Lung Injury
Beijing Hospital1 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2012年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- the numbers of patients who are actually intubated
研究概览
简要总结
To assess the safety and efficacy of noninvasive positive pressure ventilation for patients with intro-pulmonary pulmonary acute lung injury and compare this with high-concentration oxygen therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •acute onset;
- •a clinical presentation of respiratory distress;
- •arterial oxygen tension/inspired oxygen fraction (PaO2/FIO2) < 300 mmHg but > 200 mmHg while breathing oxygen delivered by a conventional Venturi device at a maximum concentration (50%);
- •presence of bilateral pulmonary infiltrates on posteroanterior chest radiograph;
- •no evidence of left heart failure as assessed by echocardiography and/or a pulmonary artery wedge pressure of <18 mm Hg.
- •the cause of ALI is consider to be intro-pulmonary.
排除标准
- •age <18 yrs;
- •Glasgow Coma Scale < 11;
- •airway or facial injury;
- •pneumothorax or pneumomediastinum;
- •unable to spontaneously clear secretions from the airways;
- •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) of other causes;
- •severe ventricular arrhythmia or unstable myocardial ischemia;
- •severe organ dysfunction (Sequential Organ Failure Assessment score > 3);
- •end-stage patients who were expected to survive < 6 months;
- •severe abdominal distension;
- •refusal to receive NPPV;
- •the cause of ALI is consider to be extrapulmonary;
- •unable to cooperate with NPPV application;
- •active upper gastrointestinal bleeding.
研究组 & 干预措施
Control
Active Comparator
干预措施: oxygen therapy (Procedure)
NPPV
Experimental
干预措施: noninvasive positive pressure ventilation (Procedure)
结局指标
主要结局
the numbers of patients who are actually intubated
时间窗: 1 year
numbers of patients who met the intubation criteria
时间窗: 1 year
次要结局
- inhospital mortalities(1 year)
- intensive care unit mortalities(1 year)
研究者
Chen Wang
vice president
Beijing Hospital
研究点 (1)
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