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临床试验/NL-OMON45335
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

Academisch Medisch Centrum0 个研究点目标入组 980 人开始时间: 待定最近更新:
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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