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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: t.d.vermeulen@amsterdamumc.nl
• Phone: + 31 020 566 2533

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.