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Protective mechanical ventilation during surgery on the abdomen with general anesthesia.

Protective Ventilation During General Anesthesia for Abdominal Surgery: A Randomized Controlled Trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23359
Enrollment
900
Registered
2010-09-16
Start date
2011-02-01
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-operative respiratory failure

Interventions

1. The conventional group will be ventilated with low PEEP (max 2cm H2O), without recruitment
2. The interventional groep will be ventilated with higher PEEP (12cm H2O), with intra-operative recruitment maneuvres.

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Planned elective abdominal surgery; 2. General anesthesia with intravenous medication; 3. High or intermediate risk for postoperative pulmonary complications.

Exclusion criteria

Exclusion criteria: 1. Age 40 kg/m2; 3. Laparoscopic surgery; 4. Previous lung surgery (any); 5. Persistent hemodynamic instability, intractable shock (considered hemodynamic unsuitable for the study by the patient’s managing physician); 6. 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); 7. Recent immunosuppressive medication (patients receiving chemotherapy or radiation therapy, less than 2 months after chemotherapy or radiation therapy); 8. Severe cardiac disease (New York Heart Association class III or IV, or acute coronary syndrome, or persistent ventricular tachyarrhythmia’s); 9. Mechanical ventilation > than 30 minutes (e.g., in cases of general anesthesia because of surgery) within last 30 days; 10. Pregnancy (excluded by laboratory analysis); 11. Acute lung injury or acute respiratory distress syndrome expected to require prolonged postoperative mechanical ventilation; 12. Neuromuscular disease (any); 13. Consented for another interventional study or refusal to participate in the study.

Design outcomes

Primary

MeasureTime frame
Postoperative pulmonary complications: 1. Mild or severe respiratory failure; 2. ALI/ARDS; 3. Suspected pulmonary infection; 4. Pulmonary infiltrate on chest X-ray; 5. Atelectasis; 6. Pneumothorax; 7. Bronchospasm; 8. Aspiration pneumonitis; 9. Cardiopulmonary edema.

Secondary

MeasureTime frame
1. Intra–operative complications (desaturation, barotrauma, hypotension during recruitment, need for vasopressors); 2. Need for ICU admission (if not as part of routine) or ICU readmission; 3. Hospital–free days at day 90; 4. Post–operative non–pulmonary organ function; 5. Post–operative wound healing; 6. Systemic levels of markers of pulmonary inflammation, acute lung injury and markers of distal organ injury.

Contacts

Public ContactMarcus J. Schultz

Meibergdreef 9, C3-415

m.j.schultz@amc.uva.nl+31 (0)20 5662509

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)