Abstract
BackgroundPostoperative 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 (FiO2) in the strategy remains disputed. Previous trials have focused on reducing SSI by increasing the inhaled oxygen concentration but higher FiO2 (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 FiO2 added to the lung-protective ventilation strategy on the incidence of PPCs during general anesthesia for abdominal surgery.Methods and designPROtective 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-FiO2 (30% FiO2) group and (2) a high-FiO2 (80% FiO2) 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.DiscussionThe PROVIO trial assesses the effect of low versus high FiO2 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 registrationwww.ChiCTR.org.cn, identifier: ChiCTR18 00014901. Registered on 13 February 2018.
Highlights
Postoperative pulmonary complications (PPCs) are the most common perioperative complications following surgical site infection (SSI)
Even if there is no significant difference in pulse oximetry and the oxygenation index for several time-points with 30 or 80% Inspiratory oxygen fraction (FiO2) intraoperatively, hyperoxia and substantial oxygen exposure are common in clinical practice [20, 21]
Assuming a round 50% rate of PPCs in the high-FiO2 (80%) group, we calculated that a total sample size of 252 patients (126 in each group) will have 80% power to detect a relative risk reduction of 35% in PPCs between groups, at a two-sided alpha level of 0.05 and 5% drop-out
Summary
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. The trial aims at evaluating the effect of different FiO2 added to the lung-protective ventilation strategy on the incidence of PPCs during general anesthesia for abdominal surgery. About 2.0 to 5.6% of more than 234 million patients undergoing surgery develop postoperative pulmonary complications (PPCs), especially after general and vascular surgeries (approximately 40%), which makes PPCs the most common perioperative complications following surgical site infection (SSI) [1,2,3,4,5,6]. Decreased lung volumes, ventilatorinduced lung injury and atelectasis are strongly associated with the incidence of PPCs [9]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
