PROtective Ventilation with a low versus high Inspiratory Oxygen fraction(PROVIO) and its effects on postoperative pulmonary complications:protocol for a randomized controlled trial

Abstract Background Postoperative pulmonary complications (PPCs) have been the most common perioperative complication following surgical site infection, which prolongs the hospital stay and increases health care cost. Lung-protective ventilation strategy is considered better practice in abdominal surgery to prevent PPCs. The role of inspiratory oxygen fraction (FiO2) in the strategy is currently not clear and remains disputable, despite liberal oxygen administration and hyperoxia is demonstrated to be associated with respiratory mechanism changes and increased mortality in ventilated patients. The trial aims at exploring the effect of FiO2 in lung-protective ventilation strategy on PPCs. Methods PROtective Ventilation with a low versus high Inspiratory Oxygen fraction trial(PROVIO)is a single-center, prospective, randomized, controlled trial planning to recruit 252 patients under abdominal surgery lasting for at least 2 hours. The patients are randomly assigned to (1) a low FiO2 (30% FiO2) group and (2) a high FiO2 (80% FiO2) in lung-protective ventilation strategy. The primary outcome of the study is the occurrence of PPCs within the first 7 days postoperatively. Secondary outcomes include the severity grade of PPCs, the occurrence of postoperative extrapulmonary complications and all-cause mortality within the first 7 and 30 days postoperatively. Discussion PROVIO trial specially assesses the effect of low versus high FiO2 in lung-protective ventilation strategy on PPCs and the results will provide practical approaches to intraoperative oxygen management. Trial registration number Registered at www.ChiCTR.org.cn on 13 February 2018 with identifier no. ChiCTR18 00014901.