To evaluate whether a perioperative open-lung ventilation strategy prevents postoperative pulmonary complications after elective on-pump cardiac surgery. Methods: In a pragmatic, randomized, multicenter, controlled trial, we assigned patients planned for on-pump cardiac surgery to either a conventional ventilation strategy with no ventilation during cardiopulmonary bypass (CPB) and lower perioperative positive end-expiratory pressure (PEEP) levels (2 cm H 2 O) or an open-lung ventilation strategy that included maintaining ventilation during CPB along with perioperative recruitment maneuvers and higher PEEP levels (8 cm H 2 O). All study patients were ventilated with low-tidal volumes before and after CPB (6 to 8 ml/kg of predicted body weight). The primary end point was a composite of pulmonary complications occurring within the first 7 postoperative days. Results: Among 493 randomized patients, 488 completed the study (mean age, 65.7 years; 360 (73.7%) men; 230 (47.1%) underwent isolated valve surgery). Postoperative pulmonary complications occurred in 133 of 243 patients (54.7%) assigned to open-lung ventilation and in 145 of 245 patients (59.2%) assigned to conventional ventilation (p = 0.32). Open-lung ventilation did not significantly reduce the use of high-flow nasal oxygenotherapy (8.6% vs 9.4%; p = 0.77), non-invasive ventilation (13.2% vs 15.5%; p = 0.46) or new invasive mechanical ventilation (0.8% vs 2.4%, p = 0.28). Mean alive ICU-free days at postoperative day 7 was 4.4 ± 1.3 days in the open-lung group vs 4.3 ± 1.3 days in the conventional group (mean difference, 0.1 ± 0.1 day, p = 0.51). Extra-pulmonary complications and adverse events did not significantly differ between groups.

BackgroundPostoperative pulmonary complications (PPCs) are frequent after on-pump cardiac surgery. Cardiac surgery results in a complex pulmonary insult leading to high susceptibility to perioperative pulmonary atelectasis. For technical reasons, ventilator settings interact with the surgical procedure and traditionally, low levels of positive end-expiratory pressure (PEEP) have been used. The objective is to compare a perioperative, multimodal and surgeon-controlled open-lung approach with conventional protective ventilation with low PEEP to prevent PPCs in patients undergoing cardiac surgery.Methods/designThe perioperative open-lung protective ventilation in cardiac surgery (PROVECS) trial is a multicenter, two-arm, randomized controlled trial. In total, 494 patients scheduled for elective cardiac surgery with cardiopulmonary bypass (CPB) and aortic cross-clamp will be randomized into one of the two treatment arms. In the experimental group, systematic recruitment maneuvers and perioperative high PEEP (8 cmH2O) are associated with ultra-protective ventilation during CPB. In this group, the settings of the ventilator are controlled by surgeons in relation to standardized protocol deviations. In the control group, no recruitment maneuvers, low levels of PEEP (2 cmH2O) and continuous positive airway pressure during CPB (2 cmH2O) are used. Low tidal volumes (6–8 mL/kg of predicted body weight) are used before and after CPB in each group. The primary endpoint is a composite of the single PPCs evaluated during the first 7 postoperative days.DiscussionThe PROVECS trial will be the first multicenter randomized controlled trial to evaluate the impact of a perioperative and multimodal open-lung ventilatory strategy on the occurrence of PPCs after on-pump cardiac surgery. The trial design includes standardized surgeon-controlled protocol deviations that guarantee a pragmatic approach. The results will help anesthesiologists and surgeons aiming to optimize ventilatory settings during cardiac surgery.Trial registrationClinical Trials.gov, NCT 02866578. Registered on 15 August 2016. Last updated 11 July 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2967-y) contains supplementary material, which is available to authorized users.

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