Protective ventilation during general anesthesia for abdominal surgery * a randomized controlled trial
- Conditions
- Ventilator associated lung injury10038716
- Registration Number
- NL-OMON36531
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
- Planned elective abdominal surgery
- General anesthesia with intravenous medication
- High or intermediate risk for postoperative pulmonary complications (ARISCAT risk score * 26)
- Age < 18 years
- Body mass index > 40 kg/m2
- Laparoscopic surgery
- Previous lung surgery (any)
- Persistent hemodynamic instability, intractable shock (considered hemodynamic 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 or repeated systemic corticosteroid therapy for acute exacerbations of COPD)
- Recent immunosuppressive medication (patients receiving chemotherapy or radiation therapy, within the last 2 months)
- Severe cardiac disease (New York Heart Association class III or IV, or acute coronary syndrome, or persistent ventricular tachyarrhythmia*s)
- Mechanical ventilation > than 30 minutes within last 30 days
(e.g., in cases of general anesthesia because of surgery)
- Pregnancy (excluded by laboratory analysis)
- Acute lung injury or acute respiratory distress syndrome expected to require prolonged postoperative mechanical ventilation
- Neuromuscular disease (any)
- Consented for another interventional study or refusal to participate in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Post-operative pulmonary complications (for definitions see appendix ii):<br /><br>Mild respiratory failure, severe respiratory failure, ALI/ARDS, suspected<br /><br>pulmonary infection, pulmonary infiltrate, pleural effusion, atelectasis,<br /><br>pneumothorax, bronchospasm, aspiration pneumonitis, cardiopulmonary edema. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Intra*operative complications, need for ICU admission (if not as part of<br /><br>routine) or ICU readmission, hospital*free days at day 90, post*operative non*<br /><br>pulmonary organ function (see appendix ii); post*operative wound healing;<br /><br>systemic levels of markers of pulmonary inflammation, acute lung injury and<br /><br>markers of distal organ injury.</p><br>