NCT00182195已完成3 期
A Randomized Trial of a Lung-Open Ventilation Strategy in Acute Lung Injury
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 980
- 试验地点
- 1
- 主要终点
- Hospital Mortality
研究概览
简要总结
A multinational, randomized trial comparing two lung protecting strategies of respiratory life support among critically ill patients with severe lung injury.
详细描述
To compare an innovative Lung Open Ventilation strategy with a proven low tidal volume strategy, hypothesizing that the Lung Open Ventilation strategy may reduce mortality, other organ dysfunction, and the duration of mechanical ventilation, intensive care, and hospital stay.
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
- •Invasive mechanical ventilation
- •Acute respiratory insufficiency (within past 28 days)
- •Bilateral infiltrates on frontal chest radiograph
- •Hypoxemia, defined as PaO2/FiO2<=250
排除标准
- •Primary cause of respiratory failure is cardiac
- •Anticipated duration of mechanical ventilation < 48 hours
- •Inability to wean other experimental ventilation strategies
- •Severe chronic respiratory disease
- •Neuromuscular disease that will prolong mechanical ventilation
- •Conditions where hypercapnia-induced intracranial hypertension should be avoided
- •Morbid obesity (> 1Kg per cm body weight)
- •Pregnancy
- •Very unlikely to survive and lack of commitment to life support Underlying irreversible condition with 6 month mortality >= 50%
- •Greater than 48 hours elapsed since first eligible
- •Current participation in competing trial
- •Lack of physician, patient or proxy consent
结局指标
主要结局
Hospital Mortality
次要结局
- Incidence of barotraumas
- Mortality attributed to respiratory failure
- Duration of respiratory failure and duration of mechanical failure
- Evaluation of respiratory function during mechanical ventilation
- Non-respiratory organ dysfunction
研究者
研究点 (1)
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