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

Completed

• Conditions: Ventilator associated lung injury; 10038716

• Registration Number: NL-OMON44595
• Lead Sponsor: Technische Universität Dresden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

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
• 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Postoperative pulmonary complications:<br /><br>Aspiration pneumonitis<br /><br>Bronchospasm<br /><br>Mild respiratory failure<br /><br>Moderate respiratory failure<br /><br>Severe respiratory failure<br /><br>ARDS<br /><br>Pulmonary infection<br /><br>Atelectasis<br /><br>Cardiopulmonary edema<br /><br>Pleural effusion<br /><br>Pneumothorax<br /><br>New pulmonary infiltrates</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints include intra-operative complications, need for<br /><br>postoperative ventilatory support (invasive and/or non-invasive ventilation),<br /><br>need for unexpected ICU admission or ICU readmission, the number of hospital-<br /><br>free days and 90-day survival/mortality.</p><br>