NL-OMON45335已完成不适用
REstricted versus Liberal positive end*expiratory pressure in patients without Acute respiratory distress syndrome (RELAx) * a multicenter randomized controlled trial - RELAx
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 980
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64(—)
入选标准
- •* Admission to an ICU participating in this trial
- •* Need for invasive ventilation
- •* An expected duration of ventilation > 24 hours
排除标准
- •* Age less than 18 years
- •* Patient previously randomized in this RCT
- •* Patient participating in another RCT with the same endpoint or interventions possibly compromising this study outcome
- •* Patients with ongoing cardiac ischemia due to cardiac infarction and failed revascularization, patients with increased and uncontrollable intracranial pressure (of * 18 mmHg), 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)
- •* Patient with a clinical diagnosis of ARDS or possible ARDS with a PaO2/ FiO2 <200 mmHg
- •* Invasive ventilation longer than 12 hours directly preceding 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
研究者
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