Douin David J, Rice John D, Xiao Mengli, Jackson Conner L, Anderson Erin L, Cheng Alex C, Cwik Jessica, Beaty Laurel E, Wild Jessica L, Beyene Robel T, Britton Garrett W, Corcos Alain C, Dale Elizabeth L, Hwang James, Jansen Jan O, Self Wesley H, Slater Julia C, Steinwand Aimee, Wiktor Arek J, Ziembicki Jenny, Schauer Steven G, Bebarta Vikhyat S, Cancio Leopoldo, Ginde Adit A
From the Department of Anesthesiology (D.J.D.), University of Colorado School of Medicine, Aurora, Colorado; Department of Biostatistics (J.D.R.), University of Michigan School of Public Health, Ann Arbor, Michigan; Department of Biostatistics and Informatics (M.X., C.L.J., L.E.B.), Colorado School of Public Health; Department of Emergency Medicine (E.L.A., J.C., A.S., V.S.B., A.A.G.), University of Colorado School of Medicine, Aurora, Colorado; Department of Biomedical Informatics (A.C.C.), Vanderbilt University Medical Center, Nashville, Tennessee; Department of Biostatistics and Informatics (J.L.W.), Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, Colorado; Department of Surgery (R.T.B.), Vanderbilt University Medical Center, Nashville, Tennessee; US Army Burn Center, US Army Institute of Surgical Research (G.W.B.), Houston, Texas; Department of Medicine (G.W.B.), Meadville Medical Center, Meadville; Department of Surgery (A.C.C., J.Z.), University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; Department of Surgery (E.L.D., J.C.S.), University of Cincinnati, Cincinnati, Ohio; Department of Surgery (J.H., J.O.J.), University of Alabama at Birmingham, Birmingham, Alabama; Vanderbilt Institute for Clinical & Translational Research (W.H.S.), Vanderbilt University Medical Center, Nashville, Tennessee; Department of Surgery (A.J.W.), University of Colorado School of Medicine, Aurora, Colorado; US Army Institute of Surgical Research (S.G.S.), Department of Emergency Medicine (S.G.S.), Brooke Army Medical Center, Joint Base San Antonio-Fort Sam Houston, San Antonio, Texas; Center for COMBAT Research (V.S.B.), University of Colorado School of Medicine, Aurora, Colorado; US Army Burn Center (L.C.), US Army Institute of Surgical Research, Fort Sam Houston, Texas.
J Trauma Acute Care Surg. 2025 Jul 3. doi: 10.1097/TA.0000000000004712.
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 [SpO2] 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.
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 SpO2 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 (SpO2 < 88%), in-hospital mortality, and adverse events.
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 (SpO2 > 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).
Targeting normoxemia did not increase supplemental oxygen-free days among adults with acute thermal burns, but safely maintained clinical outcomes.
Therapeutic Care/Management; Level I.
ClinicalTrials.gov Identifier: NCT04534972.
补充氧气对于救治成年急性热烧伤患者至关重要，但可能使患者吸入过量氧气。我们试图确定在一家专业烧伤病房收治的成年急性热烧伤患者中，将血氧正常（外周血氧饱和度[SpO2] 90 - 96%）作为目标的安全性和有效性。我们假设将血氧正常作为目标会增加无补充氧气天数（SOFDs），并安全地减少高氧血症暴露。
在这项多中心整群随机、阶梯式楔形试验中，我们将美国的六个烧伤中心随机分组，使其在2021年1月15日至2022年10月15日期间每隔三个月从常规治疗过渡到目标血氧正常治疗。在常规治疗中，补充氧气由治疗医生决定。在目标血氧正常治疗中，我们规定只要SpO2 > 96%，就减少补充氧气的用量。主要结局是SOFD，定义为存活且至第28天未接受补充氧气的天数。安全性结局包括低氧血症（SpO2 < 88%）、住院死亡率和不良事件。
入组的1437例患者平均年龄48岁，26%为女性，38%为全层烧伤，平均烧伤总面积为11%。血氧正常状态下所花费时间的比例从常规治疗组的77%增加到目标血氧正常治疗组的81%。高氧血症（SpO2 > 96%）状态下所花费时间从22%降至17%，两组间低氧血症情况相似（0.7%对0.8%）。目标血氧正常治疗组的SOFD原始平均数为18.8天，常规治疗组为17.2天（调整后平均差[aMD]，0.90天；95%置信区间[CI]， - 0.77至2.57；p = 0.29）。至第90天无住院天数，目标血氧正常治疗组（71天）多于常规治疗组（70天）（aMD，3.47天；95% CI，0.19 - 6.76）。至第90天，目标血氧正常治疗组有36例（5.7%）患者发生住院死亡，常规治疗组有65例（8.1%）患者发生住院死亡（调整后风险比[aHR]，0.66；95% CI，0.31 - 1.42）。
在成年急性热烧伤患者中，将血氧正常作为目标并未增加无补充氧气天数，但安全地维持了临床结局。
治疗护理/管理；I级。
ClinicalTrials.gov标识符：NCT04534972。
