An International Phase III Randomised Trial Comparing in Severe Exacerbations of Chronic Obstructive Pulmonary Disease the Efficacy of Helium/Oxygen Versus Air/Oxygen Administered During Spontaneous Breathing and Intermittent Non-Invasive Ventilation.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 446
- 试验地点
- 16
- 主要终点
- Reduction of NIV failure
研究概览
简要总结
The primary objective of the study is to evaluate the efficacy of Helium/Oxygen (He/O2) 78%/22% compared to a conventional Air/O2 mixture in reducing endotracheal intubation rate and mortality in patients with severe hypercapnic exacerbations of Chronic Obstructive Pulmonary Disease (COPD) during their index Intensive/Intermediate Care Unit (ICU) stay.
详细描述
Patients eligible for this study are critically ill patients with COPD admitted in Intensive Care Unit for an exacerbation of their chronic disease with hypercapnic acute respiratory failure. The patients will receive an Helium/Oxygen mixture or an Air/Oxygen mixture for a maximum of 72 hours during Non-Invasive Ventilation (NIV) and NIV-free sessions.
During NIV sessions, gas mixtures will be administered using a ventilator suitable for NIV with either He/O2 or Air/O2 and a NIV facemask.
Patients will be followed until hospital discharge and then contacted by phone up to the 6th month after randomization.
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with known or suspected COPD
- •Patient presenting current exacerbation of COPD with hypercapnic acute respiratory failure
- •Patient eligible for Non-Invasive Ventilation (NIV)
- •Patient admitted in an ICU
排除标准
- •Patient who had lung transplant
- •Patient having a contraindication to NIV
- •Patient with tracheostomy
- •Patient requiring Oxygen flow rate > 6 L/min or Inspired Oxygen Fraction (FIO2) > 0.50
- •Patient admitted in the ICU for more than 24 hours and/or having received NIV in ICU for more than 6 hours (in total) for the current exacerbation of COPD
研究组 & 干预措施
Air/Oxygen
Air/Oxygen will be administered for a maximum of 72 hours.
干预措施: Air/Oxygen (Drug)
Helium/Oxygen
Helium/Oxygen 78%/22% will be administered for a maximum of 72 hours.
干预措施: Helium/Oxygen 78%/22% (Drug)
结局指标
主要结局
Reduction of NIV failure
时间窗: 10 days (average)
Endotracheal intubation and/or death
次要结局
- Adverse events(6 months (post-randomization))
- Medico-economic parameters(6 months)
- Duration of invasive ventilation(10 days (average))
- Duration of NIV sessions(10 days (average))
- Duration of ICU stay and duration of index hospitalisation(10 days (average))
- Physiological and laboratory parameters(10 days (average))
- Time interval between the discharge of the index ICU stay and the first re-admission in ICU for severe exacerbation of COPD(6 months (post-randomization))