Douin David J, Rice John D, Anderson Erin L, Jackson Conner L, Cheng Alex C, Xiao Mengli, Cwik Jessica, Beaty Laurel E, Wild Jessica L, Daya Mohamud R, Doshi Pratik B, Eastham Shannon C, Goodman Michael D, Gunn Scott R, Haukoos Jason S, Hudson Jessica A, Jansen Jan O, McMullan Jason T, Rizzo Julie A, Schreiber Martin A, Self Wesley H, Semler Matthew W, Steinwand Aimee, Werner Nicole, Bebarta Vikhyat S, Schauer Steven G, Ginde Adit A
Department of Anesthesiology, University of Colorado School of Medicine, Aurora.
Department of Biostatistics, University of Michigan School of Public Health, Ann Arbor.
JAMA Netw Open. 2025 Mar 3;8(3):e252093. doi: 10.1001/jamanetworkopen.2025.2093.
Supplemental oxygen is fundamental to caring for critically injured adults but can expose them to excess inspired oxygen.
To determine the safety and effectiveness of targeting normoxemia in critically ill trauma patients.
DESIGN, SETTING, AND PARTICIPANTS: This multicenter, stepped-wedge, cluster randomized clinical trial compared targeted normoxemia (defined as a peripheral oxygen saturation [Spo2] of 90% to 96%) with usual care among adult trauma patients admitted to an intensive care unit (ICU) at 8 level I trauma centers across the US. These trauma centers were randomized at 3-month intervals when they crossed over from usual care to targeting normoxemia. Eligible patients were enrolled between July 15, 2020, and November 14, 2022. All statistical analyses were performed from April 2023 to November 2024 according to intention-to-treat approach.
In the usual care group, supplemental oxygen was determined by treating clinicians. In the targeted normoxemia group, a multimodal educational and informatics intervention encouraged decreasing the supplemental oxygen administered whenever Spo2 exceeded 96%.
The primary outcome was supplemental oxygen-free days (SOFDs), defined as the number of days alive and not receiving supplemental oxygen through day 28. Safety outcomes included hypoxemia (defined as Spo2 <88%) during the ICU admission, in-hospital mortality, and adverse events.
A total of 12 487 patients were enrolled (mean [SD] age, 51.7 [21.1] years; 8799 males [70.5%]; mean [SD] Injury Severity Score, 19.6 [12.0]). The proportion of ICU time spent in normoxemia increased from 56.2% in the usual care group to 71.6% in the targeted normoxemia group. Hyperoxemia (defined as Spo2 >96%) decreased from 42.4% in the usual care group to 26.7% in the targeted normoxemia group, and hypoxemia was similar between groups (1.1% vs 1.1%). The raw mean (SD) number of SOFDs was 19.6 (10.3) days for the targeted normoxemia group and 17.5 (10.4) days for the usual care group (adjusted mean difference [AMD], 0.32 [95% CI, -0.37 to 1.00] days; P = .30). Among patients not receiving mechanical ventilation at ICU admission, mean SOFDs were greater in the targeted normoxemia group than in the usual care group (22.6 [8.30] days vs 20.6 [8.86] days; AMD, 0.75; 95% CI, 0.00-1.50 days). The mean (SD) time for weaning to room air was 1.6 (3.2) days for the targeted normoxemia group and 2.7 (4.0) days for the usual care group (adjusted hazard ratio [AHR], 1.23; 95% CI, 1.13-1.33 days). In-hospital mortality to day 90 occurred in 563 patients (9.9%) in the targeted normoxemia and 732 patients (10.7%) in the usual care group (AHR, 1.05; 95% CI, 0.83-1.33). No adverse events were reported in either group.
This randomized clinical trial showed that targeting normoxemia did not increase the number of SOFDs but safely reduced supplemental oxygen use among critically ill trauma patients.
ClinicalTrials.gov Identifier: NCT04534959.
补充氧气是救治重伤成年患者的基本措施，但可能使他们吸入过量氧气。
确定在重症创伤患者中实现正常血氧饱和度目标的安全性和有效性。
设计、地点和参与者：这项多中心、阶梯式楔形、整群随机临床试验，将目标正常血氧饱和度（定义为外周血氧饱和度[Spo₂]为90%至96%）与美国8个一级创伤中心重症监护病房（ICU）收治的成年创伤患者的常规治疗进行比较。这些创伤中心每隔3个月进行随机分组，从常规治疗过渡到目标正常血氧饱和度治疗。符合条件的患者于2020年7月15日至2022年11月14日入组。所有统计分析均在2023年4月至2024年11月根据意向性分析方法进行。
在常规治疗组中，补充氧气由治疗医生决定。在目标正常血氧饱和度组中，多模式教育和信息学干预措施鼓励在Spo₂超过96%时减少补充氧气的使用。
主要结局是无补充氧气天数（SOFDs），定义为至第28天存活且未接受补充氧气的天数。安全性结局包括ICU住院期间的低氧血症（定义为Spo₂<88%）、住院死亡率和不良事件。
共纳入12487例患者（平均[标准差]年龄，51.7[21.1]岁；8799例男性[70.5%]；平均[标准差]损伤严重度评分，19.6[12.0]）。常规治疗组在正常血氧饱和度下度过的ICU时间比例从56.2%增加到目标正常血氧饱和度组的71.6%。高氧血症（定义为Spo₂>96%）从常规治疗组的42.4%降至目标正常血氧饱和度组的26.7%，两组低氧血症发生率相似（1.1%对1.1%）。目标正常血氧饱和度组SOFDs的原始平均（标准差）天数为19.6（10.3）天，常规治疗组为17.5（10.4）天（调整后平均差异[AMD]，0.32[95%CI，-0.37至1.00]天；P = 0.30）。在ICU入院时未接受机械通气的患者中，目标正常血氧饱和度组的平均SOFDs高于常规治疗组（22.6[8.30]天对20.6[8.86]天；AMD，0.75；95%CI，0.00 - 1.50天）。目标正常血氧饱和度组脱机至室内空气的平均（标准差）时间为1.6（3.2）天，常规治疗组为2.7（4.0）天（调整后风险比[AHR]，1.23；95%CI，1.13 - 1.33天）。至第90天，目标正常血氧饱和度组563例患者（9.9%）发生住院死亡，常规治疗组732例患者（10.7%）发生住院死亡（AHR，1.05；95%CI，0.83 - 1.33）。两组均未报告不良事件。
这项随机临床试验表明，目标正常血氧饱和度并未增加SOFDs的数量，但安全地减少了重症创伤患者补充氧气的使用。
ClinicalTrials.gov标识符：NCT04534959。
