Department of Anesthesiology, Vanderbilt University Medical Center and Vanderbilt University School of Medicine, Nashville, Tennessee.
Department of Biostatistics, Vanderbilt University Medical Center and Vanderbilt University School of Medicine, Nashville, Tennessee.
JAMA Surg. 2024 Oct 1;159(10):1106-1116. doi: 10.1001/jamasurg.2024.2906.
Liberal oxygen (hyperoxia) is commonly administered to patients during surgery, and oxygenation is known to impact mechanisms of perioperative organ injury.
To evaluate the effect of intraoperative hyperoxia compared to maintaining normoxia on oxidative stress, kidney injury, and other organ dysfunctions after cardiac surgery.
DESIGN, SETTING, AND PARTICIPANTS: This was a participant- and assessor-blinded, randomized clinical trial conducted from April 2016 to October 2020 with 1 year of follow-up at a single tertiary care medical center. Adult patients (>18 years) presenting for elective open cardiac surgery without preoperative oxygen requirement, acute coronary syndrome, carotid stenosis, or dialysis were included. Of 3919 patients assessed, 2501 were considered eligible and 213 provided consent. Of these, 12 were excluded prior to randomization and 1 following randomization whose surgery was cancelled, leaving 100 participants in each group.
Participants were randomly assigned to hyperoxia (1.00 fraction of inspired oxygen [FiO2]) or normoxia (minimum FiO2 to maintain oxygen saturation 95%-97%) throughout surgery.
Participants were assessed for oxidative stress by measuring F2-isoprostanes and isofurans, for acute kidney injury (AKI), and for delirium, myocardial injury, atrial fibrillation, and additional secondary outcomes. Participants were monitored for 1 year following surgery.
Two hundred participants were studied (median [IQR] age, 66 [59-72] years; 140 male and 60 female; 82 [41.0%] with diabetes). F2-isoprostanes and isofurans (primary mechanistic end point) increased on average throughout surgery, from a median (IQR) of 73.3 (53.1-101.1) pg/mL at baseline to a peak of 85.5 (64.0-109.8) pg/mL at admission to the intensive care unit and were 9.2 pg/mL (95% CI, 1.0-17.4; P = .03) higher during surgery in patients assigned to hyperoxia. Median (IQR) change in serum creatinine (primary clinical end point) from baseline to postoperative day 2 was 0.01 mg/dL (-0.12 to 0.19) in participants assigned hyperoxia and -0.01 mg/dL (-0.16 to 0.19) in those assigned normoxia (median difference, 0.03; 95% CI, -0.04 to 0.10; P = .45). AKI occurred in 21 participants (21%) in each group. Intraoperative oxygen treatment did not affect additional acute organ injuries, safety events, or kidney, neuropsychological, and functional outcomes at 1 year.
Among adults receiving cardiac surgery, intraoperative hyperoxia increased intraoperative oxidative stress compared to normoxia but did not affect kidney injury or additional measurements of organ injury including delirium, myocardial injury, and atrial fibrillation.
ClinicalTrials.gov Identifier: NCT02361944.
在手术过程中，通常会给患者提供富氧（高氧），已知氧合作用会影响围手术期器官损伤的机制。
评估术中高氧与维持正常氧合相比，对心脏手术后氧化应激、肾损伤和其他器官功能障碍的影响。
设计、地点和参与者：这是一项在 2016 年 4 月至 2020 年 10 月期间在一家三级护理医疗中心进行的参与者和评估者双盲、随机临床试验，随访时间为 1 年。纳入的患者为择期开胸心脏手术、无术前吸氧需求、无急性冠状动脉综合征、颈动脉狭窄或透析的成年患者（>18 岁）。在评估的 3919 名患者中，2501 名被认为符合条件，213 名患者表示同意。其中，12 名在随机分组前被排除，1 名在随机分组后手术被取消，每组各有 100 名参与者。
参与者被随机分配接受高氧（1.00 吸入氧分数[FiO2]）或正常氧（维持氧饱和度 95%-97%所需的最低 FiO2）治疗。
参与者通过测量 F2-异前列腺素和异呋喃来评估氧化应激，评估急性肾损伤（AKI）和谵妄、心肌损伤、心房颤动以及其他次要结果。参与者在手术后监测 1 年。
研究了 200 名参与者（中位数[IQR]年龄，66 [59-72]岁；140 名男性，60 名女性；82 [41.0%]患有糖尿病）。F2-异前列腺素和异呋喃（主要的机制终点）在手术过程中平均升高，从基线时的中位数（IQR）73.3（53.1-101.1）pg/mL 升高到入住重症监护病房时的峰值 85.5（64.0-109.8）pg/mL，在接受高氧治疗的患者中，手术期间升高了 9.2pg/mL（95%CI，1.0-17.4；P=0.03）。从基线到术后第 2 天的血清肌酐中位数（IQR）变化（主要临床终点）在接受高氧治疗的参与者中为 0.01mg/dL（-0.12 至 0.19），在接受正常氧治疗的参与者中为-0.01mg/dL（-0.16 至 0.19）（中位数差异，0.03；95%CI，-0.04 至 0.10；P=0.45）。两组各有 21 名（21%）参与者发生 AKI。术中氧疗并未影响其他急性器官损伤、安全事件或术后 1 年的肾脏、神经心理和功能结局。
在接受心脏手术的成年人中，与正常氧合相比，术中高氧增加了术中氧化应激，但并未影响肾损伤或其他器官损伤的额外测量指标，包括谵妄、心肌损伤和心房颤动。
ClinicalTrials.gov 标识符：NCT02361944。
