Trial: Intraoperative Normoxia versus Hyperoxia during Maintenance Anesthesia to Reduce Postoperative Complications
PI: Frederic T. (Josh) Billings, MD, MSCI
PI Site: Vanderbilt University Medical Center
Summary: This cluster-randomized, cluster-crossover, multi-center pragmatic clinical trial will test the hypothesis that intraoperative normoxia reduces kidney, heart, and lung injury compared to hyperoxia.
More Information: Organ injury remains common following surgery, and data suggest that intraoperative oxygen administration affects this outcome. There is variability in the fraction of inspired oxygen anesthesiologists administer to patients during surgery, however, and conflicting evidence of the relative harms of hyperoxia versus normoxia. Anesthesiologists are well-positioned to determine the effect of oxygen administration on patients during surgery because anesthesiologists control the FIO2 for every surgical patient, continuously monitor for disturbances in oxygen delivery to tissues, and routinely assess patients for postoperative complications. We will recruit and randomize 8-15 MPOG centers (clusters) to deliver normoxia or hyperoxia (intervention) for a month and then alternate the intervention each month for one year. Most patients who receive mechanical ventilation during surgery will be eligible to participate, and this study design will provide a large number of patients over a relatively short period of time, the opportunity to measure the effect of the intervention within each center and across centers, and determine if normoxia or hyperoxia reduces a composite of kidney, heart, and lung injury. We will support this study with a UG3/UH3 grant from the NIH.