Extracorporeal Lung Assist to Avoid Intubation in Patients Failing Noninvasive Ventilation for Acute Hypercapnic Respiratory Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Number of Patients With Need for Intubation for Invasive Mechanical Ventilation
研究概览
简要总结
The study´s intention is to evaluate the feasibility, safety and effectiveness of a pump driven extracorporeal device for removal of carbon dioxide from the blood in oder to avoid intubation and invasive mechanical ventilation in patients with acute respiratory failure retaining carbon dioxide due to the failure of their ventilatory muscle pump and not responding to prior non-invasive mask ventilation.
详细描述
The study´s intention is to evaluate the feasibility, safety and effectiveness of a pump driven extracorporeal device for removal of carbon dioxide from the blood in oder to avoid intubation and invasive mechanical ventilation in patients with acute respiratory failure retaining carbon dioxide due to the failure of their ventilatory muscle pump and not responding to prior non-invasive mask ventilation. Since intubation with subsequent (prolonged) invasive mechanical ventilation is associated with considerable side effects this new strategy has the potential to improve overall clinical outcome in this selected patient group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •acute or acute-on-chronic hypercapnic respiratory insufficiency (pH ≤ 7,35, PaCO2 > 45 mmHg)
- •failure of noninvasive ventilation
- •fulfilling criteria for endotracheal intubation
排除标准
- •under 18 years of age
- •prior inclusion in other interventional study
- •pregnancy
- •heparin allergy or heparin-induced thrombocytopenia type 2
- •on home non-invasive ventilator
- •"Do not resuscitate" order or moribund condition
- •life expectancy less than 6 months
- •no informed consent available
结局指标
主要结局
Number of Patients With Need for Intubation for Invasive Mechanical Ventilation
时间窗: 21 days
The number of patients in the ECLA-group who had to be intubated and mechanically ventilated under the given criteria for inclusion and exclusion is collected. Since every patient in the matched control group was intubated, the comparison of the groups shows whether the use of a pump-driven venovenous extracorporeal lung assist can reduce the frequency of intubation and mechanical ventilation.
次要结局
- Length of Non-invasive Ventilation(90 days)
- Mortality(90 days)
- Complication Rates(90 days)
- Length of Invasive Mechanical Ventilation if Intubated(90 days)
- Length of Stay in ICU(90 days)
研究者
Stefan Kluge
PD Dr. Stefan Kluge
Universitätsklinikum Hamburg-Eppendorf