REstricted Versus Liberal Positive End-Expiratory Pressure in Patients Without Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 980
- 试验地点
- 13
- 主要终点
- Ventilation-free days and alive at day 28
研究概览
简要总结
The 'REstricted versus Liberal positive end-expiratory pressure in patients without Acute respiratory distress syndrome' (RELAx) trial is a national multicenter, open randomized controlled trial in ICU patients without ARDS at start of ventilation. It will be the first RCT comparing ventilation with the lowest possible positive end-expiratory pressure (PEEP) level with ventilation with the median PEEP level currently practiced in the Netherlands that recruits a sufficient number of patients to test the hypothesis that ventilation with the lowest possible PEEP level is non-inferior to ventilation with a PEEP level of 8 cm H2O with regard to objective and patient-relevant clinical endpoints.
详细描述
Research question:
Is mechanical ventilation with the lowest possible PEEP level, as compared to mechanical ventilation with the PEEP level currently practiced, non inferior in terms of the number of ventilator-free days at days 28 in patients without ARDS?
Study design:
National multicenter, non-inferiority, open randomized controlled trial in intubated and ventilated adult ICU patients without ARDS.
Centers:
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
盲法说明
Open Label
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admission to one of the participating ICUs
- •Need for and start of invasive ventilation
- •An expected duration of ventilation > 24 hours
排除标准
- •Age less than 18 years
- •Patients with a clinical diagnosis of ARDS or possible ARDS with a PaO2/FiO2 < 200 mmHg (as the benefit of ventilation with higher PEEP levels has been proven in these patients)
- •Patients with ongoing cardiac ischemia due to cardiac infarction and failed revascularization, patients with increased and uncontrollable intracranial pressure (of ≥ 18 mmHg), patients with delayed cerebral ischemia after subarachnoid hemorrhage, patients with necrotizing fasciitis, and severe untreatable anemia such as in case of Jehovah's Witnesses (as these patients can be considered to be vulnerable to the potentially dangerous hypoxemia which could develop more often, even for a short time, in the 'restricted PEEP'-arm of this trial)
- •Patients previously randomized in this RCT
- •Patients participating in another RCT with the same clinical endpoint, or interventions possibly compromising the primary outcome
- •Invasive ventilation longer than 12 hours directly preceding the present ICU admission
- •Invasive ventilation longer than 1 hour before randomization
- •Patients with suspected or confirmed pregnancy
- •Patients with morbid obesity (body mass index > 40)
- •Patients with GOLD classification III or IV chronic obstructive pulmonary disease (COPD)
- •Patients with premorbid restrictive pulmonary disease (evidence of chronic interstitial infiltration on chest radiographs)
- •Patients in whom pulse oximetry is known to be unreliable, e.g., patients with carbon monoxide poisoning
- •Any neurologic diagnosis that can prolong duration of mechanical ventilation, e.g., patients with Guillain-Barré syndrome, high spinal cord lesion or amyotrophic lateral sclerosis, multiple sclerosis, or myasthenia gravis
- •No informed consent
结局指标
主要结局
Ventilation-free days and alive at day 28
时间窗: first 28 days after start of ventilation
The number of ventilation-free days, defined as the number of days from day 1 to day 28; the patient is alive and breathes without assistance of the mechanical ventilator, if the period of unassisted breathing lasted at least 24 consecutive hours.
次要结局
- Length of stay(first 90 days after start of ventilation)
- Mortality(first 90 days after start of ventilation)
- Pulmonary complications(daily until detubation or day 28)
- Rescue strategies for severe hypoxemia or severe atelectasis(daily until detubation or day 28)
- Days with use of hemodynamic support(daily until detubation or day 28)
- Days with use of sedation(daily until detubation or day 28)
- Therapeutic intervention scoring system (TISS)/ Nursing Activities Score (NAS)(daily until detubation or day 28)
研究者
Prof. Dr. Marcus J. Schultz
Prof. Dr. Marcus J. Schultz
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)