Low Tidal Volume Mechanical Ventilation Against No Ventilation During Cardiopulmonary Bypass in Heart Surgery (MECANO): A Randomized Controlled Trial.

BACKGROUND: Postoperative pulmonary complications are common after cardiac surgery and have been related to lung collapse during cardiopulmonary bypass (CPB). No consensus exists regarding the effects of maintaining mechanical ventilation during CPB to decrease these complications. RESEARCH QUESTION: To determine whether maintaining low-tidal ventilation (3 mL/kg 5 times/min, with positive end expiratory pressure of 5 cm H2O) during CPB (ventilation strategy) was superior to a resting-lung strategy with no ventilation (no ventilation strategy) regarding postoperative pulmonary complications, including mortality. STUDY DESIGN AND METHODS: In a randomized controlled trial, patients undergoing cardiac surgery at a single center from May 2017 through August 2019 were randomized to the ventilation or no ventilation strategy during CPB (1:1 ratio). Apart from the CPB phase, perioperative ventilation procedures were standardized. RESULTS: The study included 1,501 patients (mean age, 68.8 ± 10.3 years; 1,152 (76.7%) men; mean EuroSCORE II, 2.3 ± 2.7). Seven hundred fifty-six patients were in the ventilation strategy group, and no differences existed in baseline characteristics and types of procedures between the two groups. An intention-to-treat analysis yielded no significant difference between the ventilation and no ventilation groups regarding incidence of the primary composite outcome combining death, early respiratory failure, ventilation support beyond day 2, and reintubation, with 112 of 756 patients (14.8%) in the ventilation group vs 133 of 745 patients (17.9%) in the no ventilation group (OR, 0.80; 95% CI, 0.61-1.05; P = .11). Strict per-protocol analyses of 1,338 patients (89.1%) with equally distributed preoperative characteristics yielded similar results (OR, 0.81; 95% CI, 0.60-1.09; P = .16). Post hoc analysis of the subgroup who underwent isolated coronary artery bypass graft procedures (n = 725) showed that the ventilation strategy was superior to the no ventilation strategy regarding the primary outcome (OR, 0.56; 95% CI, 0.37-0.84; P = .005). INTERPRETATION: Among patients undergoing cardiac surgery with CPB, continuation of low tidal volume ventilation was not superior to no ventilation during CPB with respect to postoperative complications, including death, early respiratory failure, ventilation support beyond day 2, and reintubation. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT03098524; URL: www.clinicaltrials.gov.