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

BACKGROUND: Postoperative pulmonary complications (PPCs) are the most common perioperative complications following surgical site infection (SSI). They prolong the hospital stay and increase health care costs. A lung-protective ventilation strategy is considered better practice in abdominal surgery to prevent PPCs. However, the role of the inspiratory oxygen fraction (FiO(2)) in the strategy remains disputed. Previous trials have focused on reducing SSI by increasing the inhaled oxygen concentration but higher FiO(2) (80%) was found to be associated with a greater incidence of atelectasis and mortality in recent research. The trial aims at evaluating the effect of different FiO(2) added to the lung-protective ventilation strategy on the incidence of PPCs during general anesthesia for abdominal surgery. METHODS AND DESIGN: 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 undergoing abdominal surgery lasting for at least 2 h. The patients will be randomly assigned to (1) a low-FiO(2) (30% FiO(2)) group and (2) a high-FiO(2) (80% FiO(2)) group in the lung-protective ventilation strategy. The primary outcome of the study is the occurrence of PPCs within the postoperative 7 days. Secondary outcomes include the severity grade of PPCs, the occurrence of postoperative extrapulmonary complications and all-cause mortality within the postoperative 7 and 30 days. DISCUSSION: The PROVIO trial assesses the effect of low versus high FiO(2) added to a lung-protective ventilation strategy on PPCs for abdominal surgery patients and the results should provide practical approaches to intraoperative oxygen management. TRIAL REGISTRATION: www.ChiCTR.org.cn, identifier: ChiCTR18 00014901. Registered on 13 February 2018. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-019-3668-x) contains supplementary material, which is available to authorized users.