Personalized driving pressure-guided positive end-expiratory pressure in patients at risk of postoperative respiratory failure (IMPROVE-2): a multicenter, pragmatic, randomized clinical trial.

Abstract

Airway driving pressure has garnered considerable attention for lung-protective ventilation. We evaluated the clinical effectiveness of airway driving pressure as a target to individualize positive-end-expiratory pressure (PEEP) setting in mechanically ventilated patients at risk for postoperative respiratory failure. We conducted a multicenter, pragmatic, assessor-masked, randomized trial among adult patients undergoing emergency abdominal surgery in 22 hospitals in France. Patients were assigned 1:1 to receive individually adjusted highest PEEP targeting a driving pressure < 13 cmH₂O after an initial recruitment maneuver (intervention group) or to a fixed PEEP level of 5 cmH₂O (control group). The primary outcome was a composite of postoperative respiratory failure (failure to wean from the ventilator or the composite of reintubation or curative non-invasive ventilation) or all-cause mortality at 30 days. Secondary outcomes included components of the composite primary outcome. The primary outcome occurred in 87 out of 338 (25.7%) intervention patients and in 69 out of 341 (20.2%) control patients (difference, 5.5%; 95% confidence interval [CI] - 0.8 to 11.8; relative risk, 1.27; 95%CI 0.96-1.68; p = 0.08). The difference was primarily due to an increased incidence of reintubation or need for curative non-invasive ventilation among intervention patients (difference, 7.1%; 95% CI 2.5-11.9; relative risk, 1.97; 95% CI 1.24-3.11; p = 0.004). Other secondary outcomes did not differ. Among patients at risk for postoperative respiratory failure after emergency abdominal surgery, a strategy of individually adjusted highest PEEP in targeting driving pressure lower than 13 cmH₂O did not reduce postoperative respiratory failure or death. ClinicalTrials.gov Identifier: NCT03987789.