Effect of targeting normoxemia on supplemental oxygen-free days for adults with acute thermal burns: A stepped wedge cluster randomized clinical trial

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BACKGROUND: Supplemental oxygen is essential in caring for adults with acute thermal burns but can expose patients to excess inspired oxygen. We sought to determine the safety and effectiveness of targeting normoxemia (peripheral oxygen saturation [SpO 2 ] 90-96%) in adults with acute thermal burns admitted to a specialized burn unit. We hypothesized that targeting normoxemia would increase the number of supplemental oxygen-free days (SOFDs) and safely reduce exposure to hyperoxemia. METHODS: In this multicenter cluster-randomized, stepped-wedge trial, we randomized six US burn centers to cross over from usual care to targeted normoxemia at three-month intervals between January 15, 2021, and October 15, 2022. In usual care, supplemental oxygen was determined by treating clinicians. In targeted normoxemia, we specified decreasing administered supplemental oxygen whenever SpO 2 was >96%. The primary outcome was SOFD, defined as the number of days alive and not receiving supplemental oxygen through Day 28. Safety outcomes included hypoxemia (SpO 2 < 88%), in-hospital mortality, and adverse events. RESULTS: The 1,437 enrolled patients were mean age 48 years, 26% female, 38% with full-thickness burns, and 11% mean total body surface area burned. The proportion of time spent in normoxemia increased from 77% in the usual care group to 81% in the targeted normoxemia group. Time spent with hyperoxemia (SpO 2 > 96%) decreased from 22% to 17%, and hypoxemia was similar between groups (0.7% vs. 0.8%). The raw mean number of SOFD was 18.8 days for targeted normoxemia and 17.2 days for usual care (adjusted mean difference [aMD], 0.90 days; 95% confidence interval [CI], -0.77 to 2.57; p = 0.29). Hospital-free days through Day 90 were greater among the targeted normoxemia group (71 days) than the usual care group (70 days) (aMD, 3.47 days; 95% CI, 0.19-6.76). In-hospital mortality to Day 90 occurred in 36 (5.7%) targeted normoxemia patients and 65 (8.1%) usual care patients (adjusted hazard ratio [aHR], 0.66; 95% CI, 0.31-1.42). CONCLUSION: Targeting normoxemia did not increase supplemental oxygen-free days among adults with acute thermal burns, but safely maintained clinical outcomes. LEVEL OF EVIDENCE: Therapeutic Care/Management; Level I. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04534972.

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