Extracorporeal Carbon Dioxide Removal in Patients With Severe COPD Exacerbation Failing Noninvasive Ventilation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- number of patients treated with the Decap Smart failing NIV and therefore needing endotracheal intubation
研究概览
简要总结
The minimally invasive extracorporeal carbon dioxide removal may decrease the respiratory load during chronic obstructive pulmonary disease (COPD) exacerbation, reducing the need to advance the respiratory care toward invasive mechanical ventilation in patients refractory to non-invasive ventilatory support (NIV), or decreasing the need of ventilatory support in patients already invasively ventilated, thereby accelerating the weaning process.
The investigators intend to perform a multi-center experimental non randomized single arm prospective study to investigate the efficacy of the Decap Smart in reducing the intubation rate or the duration of invasive mechanical ventilation in patients with COPD treated either with NIV or invasive mechanical ventilation (IMV) for severe respiratory failure and hypercapnia. The results of the study will be compared to the data available in the literature.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •severe acute respiratory failure
- •after at least two hours of continuous application of non-invasive ventilatory support (NIV):
- •arterial pH ≤7.30 with an arterial pressure of CO2 (PaCO2) >20% of the baseline value and one of the following:
- •respiratory rate ≥30 breaths/min;
- •use of accessory muscles or paradoxical abdominal movements
排除标准
- •failure to obtain consent
- •hemodynamic instability (MAP < 60 mmHg) despite infusion of vasoactive drugs
- •contraindications to the administration of i.v. heparin (heparin induced thrombocytopenia, hemorrhage, etc.)
- •body weight >120 kg
- •contraindication to continuation of active treatment (DNR)
结局指标
主要结局
number of patients treated with the Decap Smart failing NIV and therefore needing endotracheal intubation
时间窗: 1 month
次要结局
- Adverse events(1 month)
- Hospital length of stay(18 months)
- ICU length of stay(18 months)
- Hospital mortality(60 days)
研究者
Marco Ranieri
MD Professor
University of Turin, Italy