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临床试验/NL-OMON44595
NL-OMON44595已完成不适用

PRotective Ventilation with Higher versus Lower PEEP during General Anesthesia for Surgery in OBESE Patients - The PROBESE Randomized Controlled Trial - PROBESE

Technische Universität Dresden0 个研究点目标入组 100 人开始时间: 待定最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
100

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 99(—)

入选标准

  • Patient scheduled for surgery under general anesthesia
  • Intermediate-to-high risk for postoperative pulmonary complications following surgery, according to the ARISCAT risk score (>= 26)
  • BMI >= 35 kg/m2
  • Expected duration of surgery >= 2 h

排除标准

  • Age < 18 years
  • Previous lung surgery (any)
  • Persistent hemodynamic instability, intractable shock (considered hemodynamically unsuitable for the study by the patient*s managing physician)
  • History of previous severe chronic obstructive pulmonary disease (COPD) (non-invasive ventilation and/or oxygen therapy at home, repeated systemic corticosteroid therapy for acute exacerbations of COPD)
  • Recent immunosuppressive medication (patients receiving chemotherapy or radiation therapy up to two months prior to surgery)
  • Severe cardiac disease (New York Heart Association class III or IV, acute coronary syndrome or persistent ventricular tachyarrhythmias)
  • Invasive mechanical ventilation longer than 30 minutes (e.g., general anesthesia for surgery) within last 30 days
  • Pregnancy (excluded by anamneses and/or laboratory analysis)
  • Prevalent acute respiratory distress syndrome expected to require prolonged postoperative mechanical ventilation
  • Severe pulmonary arterial hypertension, defined as systolic pulmonary artery pressure > 40 mmHg
  • Intracranial injury or tumor
  • Neuromuscular disease (any)
  • Need for intraoperative prone or lateral decubitus position
  • Need for one-lung ventilation
  • Cardiac surgery
  • Neurosurgery
  • Planned reintubation following surgery
  • Enrolled in other interventional study or refusal of informed consent

研究者

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