Using individualized ventilation strategies to reduce lung complications after minimally invasive abdominal surgery

Driving Pressure During General Anesthesia for Minimally Invasive Abdominal Surgery (GENERATOR) - a Randomized Clinical Trial

This study is testing if a personalized breathing strategy during surgery can help prevent lung problems for people having minimally invasive abdominal surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1806 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Academic / other)
• Locations: 1 site (Amsterdam, Noordholland)
• Trial ID: NCT06101511 on ClinicalTrials.gov

What this trial studies

This international multicenter randomized controlled trial aims to evaluate whether an individualized high Positive End Expiratory Pressure (PEEP) strategy can prevent postoperative pulmonary complications in patients undergoing minimally invasive abdominal surgery. Participants will receive intraoperative ventilation tailored to minimize driving pressure, with recruitment maneuvers applied as needed. The study will be conducted with patient and outcome assessors blinded to the intervention to ensure unbiased results.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 scheduled for minimally invasive abdominal surgery who are at increased risk for postoperative pulmonary complications.

Not a fit: Patients planned for open abdominal surgery or those with certain respiratory conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of postoperative pulmonary complications in at-risk patients.

How similar studies have performed: Other studies have shown promising results with individualized ventilation strategies, suggesting potential for success in this approach.

Eligibility criteria

Inclusion criteria:

1. age \> 18 years; AND
2. scheduled for minimally invasive abdominal surgery; AND
3. at increased (i.e., intermediate or high) risk of PPCs according to the 'Assess Respiratory risk in Surgical Patients in Catalonia' (ARISCAT) risk score (≥ 26 points, see Appendix I); OR at increased risk of PPCs based on the combination of age \> 40 years, scheduled surgery lasting \> 2 hours and planned to receive an intra-arterial catheter for blood pressure monitoring during the surgery; AND
4. signed written informed consent

Exclusion criteria:

1. planned for open abdominal surgery;
2. planned for surgery in lateral or prone position;
3. planned for combined abdominal and intra-thoracic surgery
4. confirmed pregnancy;
5. consent for another interventional trial during anesthesia;
6. having received invasive ventilation \> 30 minutes within the last five days;
7. any previous lung surgery;
8. history of previous severe chronic obstructive pulmonary disease (COPD) with (noninvasive) ventilation or oxygen therapy at home or repeated systemic corticosteroid therapy for acute exacerbations of COPD;
9. history of acute respiratory distress syndrome (ARDS);
10. expected to require postoperative ventilation;
11. expected hemodynamic instability or intractable shock;
12. severe cardiac disease (New York Heart Association class III or IV, acute coronary syndrome or persistent ventricular tachyarrhythmia's).

Where this trial is running

Amsterdam, Noordholland

• Amsterdam University Medical Center — Amsterdam, Noordholland, Netherlands (Recruiting)

Study contacts

• Principal investigator: Markus Hollmann, Professor — Amsterdam University Medical Center, location AMC
• Study coordinator: Tom Vermeulen, MD

Conditions Postoperative Complications; Surgery; Minimally invasive abdominal surgery; Mechanical ventilation; Positive end-expiratory pressure; Driving pressure; Postoperative pulmonary complications; Recruitment maneuver