One-lung ventilation and postoperative pulmonary complications after major lung resection surgery. A multicenter randomized controlled trial.

OBJECTIVES: The effect of one-lung ventilation (OLV) strategy based on low tidal volume (TV), application of positive end-expiratory pressure (PEEP) and alveolar recruitment maneuvers (ARM) to reduce postoperative acute respiratory distress syndrome (ARDS) and pulmonary complications (PPCs) compared to higher TV without PEEP and ARM strategy in adult patients undergoing lobectomy or pneumonectomy has not been well established. DESIGN: Multicenter, randomized, single-blind, controlled trial SETTING: 16 Italian hospital PARTICIPANTS: 880 patients undergoing elective major lung resection INTERVENTIONS: Patients were randomized to receive lower tidal volume (LTV group: 4 ml/kg predicted body weight - PBW, PEEP of 5 cmH(2)O and ARMs) or higher tidal volume (HTL group: 6 ml/kg PBW, no PEEP and no ARMs). After OLV, until extubation, both groups were ventilated using a tidal volume of 8 ml/kg and a PEEP value of 5 cmH(2)O. Primary outcome was the incidence of in-hospital ARDS. Secondary outcomes were in-hospital rate of PPCs, major cardiovascular events, unplanned ICU admission, mortality, ICU length of stay, in-hospital length of stay. MEASUREMENTS AND MAIN RESULTS: ARDS occurred in 3/438 (0.7% - 95%CI 0.1-2.0%) and in 1/442 (0.2% - 95%CI 0-1.4%) of patients in the LTV and HTV group, respectively (Risk ratio: 3.03 95%IC 0.32-29 – P = 0.372). PPCs occurred in 125/438 (28.5% - 95%CI 24.5-32.9%) and in 136/442 (30.8% - 95%CI 26.6-35.2%) of patients in the LTV and HTV group, respectively (Risk ratio: 0.93 - 95%CI 0.76-1.14 – P = 0.507). The incidence of major complications, in-hospital mortality and unplanned ICU admission, ICU and in-hospital length of stay were comparable in both groups. CONCLUSIONS: In conclusion, among adult patients undergoing elective lung major resection, both an OLV with lower tidal volume, PEEP 5 cmH2O, and ARMs and a higher tidal volume strategy resulted in low ARDS incidence and comparable postoperative complications, in-hospital length of stay and mortality.