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Clinical Trials/NL-OMON44595
NL-OMON44595
Completed
Not Applicable

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

Technische Universität Dresden0 sites100 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Technische Universität Dresden
Enrollment
100
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Not specified

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