6/29/23, 1:44 AM PROBESE Pathway Feedback Search Clinical Topics Home Studies PROBESE PROBESE Disease Obesity Trial question What is the effect of an intraoperative mechanical ventilation strategy with a higher level of PEEP and alveolar recruitment maneuvers in obese patients undergoing surgery under general anesthesia? Study design Multi-center Open label RCT Population Characteristics of study participants 70.0% female N = 1976 30.0% male 1976 patients (1381 female, 595 male) Inclusion criteria: adult patients with body mass indices 35 and substantial risk for postoperative pulmonary complications who were undergoing noncardiac, nonneurological surgery under general anesthesia Key exclusion criteria: previous lung surgery, receipt of invasive mechanical ventilation for > 30 minutes within the last 30 days, receipt of chemotherapy or radiotherapy within 2 months Interventions N=989 high level of PEEP (a PEEP level of 12 cmH O with alveolar recruitment maneuvers performed after endotracheal intubation) https://web.pathway.md/studies/recvh3VARokj9lQim 1/2 6/29/23, 1:44 AM PROBESE Pathway N=987 low level of PEEP (a PEEP level of 4 cmH O) Primary outcome Rate of postoperative pulmonary complications within the first 5 days 23.6 % 23.6 21.3 17.7 % 11.8 % 5.9 % No significant difference 0.0 % High level of PEEP Low level of PEEP No significant difference in the rate of postoperative pulmonary complications within the first 5 days (21.3% vs. 23.6%; RR 0.93, 95% CI 0.83 to 1.04) Secondary outcomes Significant decrease in hypoxemia (5% vs. 13.6%; RR 0.51, 95% CI 0.4 to 0.65) No significant difference in postoperative extrapulmonary complications (16.9% vs. 15.2%; RR 1.06, 95% CI 0.95 to 1.19) No significant difference in systemic inflammatory response syndrome (9.4% vs. 8.4%; RR 1.06, 95% CI 0.91 to 1.22) Safety outcomes No significant differences in death during the hospital stay, DIC, coma, hepatic failure, extrapulmonary infection, septic shock, severe sepsis. Significant differences in hypotension (31.6% vs. 17.2%), bradycardia (9.9% vs. 6.0%). Conclusion In adult patients with body mass indices 35 and substantial risk for postoperative pulmonary complications who were undergoing noncardiac, nonneurological surgery under general anesthesia, high level of PEEP was not superior to low level of PEEP with respect to the rate of postoperative pulmonary complications within the first 5 days. Reference Writing Committee for the PROBESE Collaborative Group of the PROtective VEntilation Network (PROVEnet) for the Clinical Trial Network of the European Society of Anaesthesiology, Thomas Bluth, Ary Serpa Neto et al. Effect of Intraoperative High Positive End-Expiratory Pressure (PEEP) With Recruitment Maneuvers vs Low PEEP on Postoperative Pulmonary Complications in Obese Patients: A Randomized Clinical Trial. JAMA. 2019 Jun 18;321(23):2292-2305. Open reference URL https://web.pathway.md/studies/recvh3VARokj9lQim 2/2