Extrapulmonary Interventional Ventilatory Support for Lung Protection in Severe Acute Respiratory Distress - a Prospective Randomized Multi Centre Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Ventilator free days within 28 days after enrollment
研究概览
简要总结
A prospective, randomized study will be performed investigating the effects of a pumpless extracorporeal interventional lung assist [iLA] on the implementation of a lung-protective ventilatory strategy in patients with acute respiratory distress syndrome [ARDS] with a PaO2/FiO2 ratio < 200. The duration of ventilation, intensive care and hospital stay and in-hospital mortality will be investigated.
详细描述
Evaluation group:
Implantation of the iLA - adaptation of the ventilation strategy, explantation of the iLA after corresponding improvement (see treatment plan for details) - weaning from the ventilation and extubation according to specified criteria.
Control group:
Ventilation strategy based on the concept of lung-protective ventilation without extracorporeal support, weaning from the ventilation and extubation according to specified criteria (see treatment plan for details).
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
- •The trial subjects are patients aged 18 years or older who have developed severe ARDS. Following the American-European Consensus Conference on ARDS, severe ARDS is defined as an oxygenation index (PaO2/FIO2) < 200 mmHg. These parameters must be present for a duration of at least 2 hours.
排除标准
- •age < 18 years
- •decompensated heart insufficiency
- •acute coronary syndrome
- •severe chronic obstructive pulmonary disease
- •advanced tumour conditions with life expectancy < 6 months
- •chronic dialysis treatment
- •lung transplant patients
- •proven Heparin-induced thrombocytopenia (HIT)
- •morbid obesity (BMI >) 40
- •Child Class B and C cirrhosis of the liver, acute fulminant hepatic failure
- •severe peripheral arterial occlusive disease (pAVK III - IV), absence of limb doppler pulse
- •brain injury (GCS < 9 + CT pathology)
结局指标
主要结局
Ventilator free days within 28 days after enrollment
时间窗: 28 days
次要结局
- hospital mortality, organ-failure free days, pulmonary gas exchange(28 days - 60 days)