Welcome to the GENERATOR study page

Study Summary

Rationale

The intraoperative driving pressure (ΔP) has an independent association with the development of postoperative pulmonary complications (PPCs) in patients receiving ventilation during general anesthesia for major surgery. Ventilation with high intraoperative positive end–expiratory pressure (PEEP) with recruitment maneuvers (RMs) that results in a low ΔP has the potential to prevent PPCs.

Study design

The GENERATOR study is an investigator−initiated multicenter double blind international randomized.

Study population

This study will include 1806 patients scheduled for major minimally invasive abdominal surgery and with an increased risk of PPCs based on: (i.) the ARISCAT risk score for PPCs (≥ 26 points), or (ii.): a combination of age > 40 years, scheduled surgery lasting > 2 hours and planned to receive an intra–arterial catheter for blood pressure monitoring during surgery.

Intervention

The intervention is intraoperative ventilation using the available ventilator with individualized high PEEP titrated to the lowest ΔP with RMs. After abdominal insufflation, patients randomized to the individualized high PEEP with RMs group will receive a RM followed by a 'decremental PEEP trial'. This is followed by a second RM after which PEEP is set at the level indicated by the decremental PEEP trial.

Main study parameters/endpoints

The primary outcome is a collapsed composite endpoint of PPCs until postoperative day five. Secondary outcomes are intraoperative complications, extrapulmonary postoperative complications, length of hospital stay and related healthcare costs.

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