Nasal High-flow Compared to Non-invasive Ventilation in Treatment of Acute Acidotic Hypercapnic Exacerbation of Chronic Obstructive Pulmonary Disease - a Randomized Controlled Noninferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 720
- 试验地点
- 12
- 主要终点
- Proportion with treatment failure of allocated respiratory support within 72 h after start of respiratory support.
研究概览
简要总结
The ELVIS study compares the nasal high-flow to non-invasive ventilation in treatment of acute acidotic hypercapnic exacerbation of chronic obstructive pulmonary disease.
详细描述
The ELVIS study is a prospective, randomized, multi-centre open label trial following a non-inferiority design to compare the nasal high-flow (NHF) to non-invasive ventilation (NIV) in treatment of acute acidotic hypercapnic exacerbation of chronic obstructive pulmonary disease. Accoring to the randomization the patient is treated with NHF or NIV until discharge. A change of device is possible, if switch criteria are fulfiled OR need for intubation criteria are met before 72h (timepoint for primary endpoint).
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
- •acute hypercapnic exacerbation of chronic obstructive pulmonary disease with pH < 7.35
- •pCO2 > 45mmHg
- •age ≥ 18 years
- •written informed consent
排除标准
- •immediate need for intubation (acc. to intubation criteria in this protocol)
- •BMI ≥ 35 kg/m²
- •established home-NIV or home-CPAP
- •end-stage disease with DNI/DNR order
- •diseases that could influence the primary endpoint: e.g. acute heart infarction, cardiogenic lung edema, acute and massive lung embolism (hypertensive), chronic dialysis with metabolic acidosis, unstable rib fracture influencing ventilation, injury to the face prohibiting use of a face mask
- •acute disease that precludes participation in the trial
- •tracheotomized patients
- •psychological/mental or other inabilities to supply required informed consent
- •participation in other interventional trials
- •suspected lack of compliance
结局指标
主要结局
Proportion with treatment failure of allocated respiratory support within 72 h after start of respiratory support.
时间窗: start of treatment until 72 hours
Treatment failure defined as 1. intubation or 2. switch to another method of non-invasive ventilation or 3. death
次要结局
- switch to another method of non-invasive ventilation within 72 hours (component of primary outcome)(start of treatment until 72 hours)
- intubation within 72 hours (component of primary outcome)(start of treatment until 72 hours)
- death within 72 hours (component of primary outcome)(start of treatment until 72 hours)
- proportion intubated within 7 calendar days after hospitalisation/randomization(start of treatment until 7 calender days after hospitalisation/randomization)
- Overall survival at day 28 and day 90(start of treatment until day 90 after start of treatment)
- (Invasive) ventilator-free days until day 28(start of treatment until day 28 after start of treatment)
- (Invasive) ventilator-free hours until the primary endpoint is reached or 72 hours, whichever comes first(start of treatment until maximum 72 hours after start of treatment)
- Intensive care unit (ICU) and hospital lengths of stay(start of treatment until discharge or day 90 after start of treatment (whichever comes first))
- Proportion requiring sedation(start of treatment until discharge or day 90 after start of treatment (whichever comes first))
研究者
Hubert Wirtz
Head of Pneumology
University of Leipzig