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Pulmonary Engineering Group




Patients enrolled

2013 of 2013

Randomization is closed!

effective February 19, 2018

200:SProtocol:Population

Population

Obese adult patients with body mass index (BMI) ≥ 35 kg/m² scheduled for open or laparoscopic surgery under general anesthesia (Screening).

Inclusion Criteria

  • Patient scheduled for open or laparoscopic surgery under general anesthesia
  • Intermediate-to-high risk for PPCs following surgery, according to the ARISCAT risk score (≥ 26)
  • BMI ≥ 35 kg/m²
  • Expected duration of surgery ≥ 2 h

Exclusion Criteria

A patient meeting any of the exclusion criteria listed below must be excluded from participating in the trial.

  • 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
  • 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
200/SProtocol/Population.txt · Last modified: 2017/06/07 10:43 by bluth

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