成人腹部大手术后高与标准 FiO2 对术后肺部并发症的影响：一项非劣效性试验。

Postoperative pulmonary complications with high versus standard FiO in adult patients undergoing major abdominal surgery: A noninferiority trial.

机构信息

Department of Anaesthesiology, Pain Medicine, and Critical Care, All India Institute of Medical Sciences, New Delhi, India.

Department of GI Surgery and Liver Transplantation, All India Institute of Medical Sciences, New Delhi, India.

出版信息

Surgery. 2024 Feb;175(2):536-542. doi: 10.1016/j.surg.2023.10.020. Epub 2023 Nov 27.

DOI:10.1016/j.surg.2023.10.020

PMID:38016902

Abstract

BACKGROUND

Despite the possible clinical benefit of high intraoperative oxygen therapy on surgical site infection, the effect on postoperative respiratory function is debatable. However, it remains yet to be elucidated whether hyperoxia due to a high fraction of inspired oxygen used in conjunction with lung protective ventilation can lead to increased incidence of postoperative pulmonary complications.

METHODS

In this noninferiority randomized trial, an intraoperative high fraction of inspired oxygen of 0.8 (group H) was compared to a standard fraction of inspired oxygen of 0.3 to 0.4 (group S) in adult patients undergoing major elective or emergency surgery. A lung protective ventilation strategy was employed in all patients, including volume control ventilation with a tidal volume of 6 to 8 mL/kg of predicted body weight, respiratory rate of 12 beats per minute, and positive end-expiratory pressure of 5 to 8 cm HO. Postoperative pulmonary complications were assessed on postoperative days 3 and 5 by the Melbourne group scale.

RESULTS

In this trial, n = 226 patients were randomized; among them, 130 patients underwent routine surgery, and 96 patients underwent emergency surgery. The median (interquartile range) of the patients was 48 (35-58) years, and 47.3% were female. Melbourne group scale scores at postoperative day 3 (median [interquartile range] 2 [1-4] in group S vs 2 [1-3] in group H; the difference in median [95% confidence interval] 0 [0, -1]; P = .13) and day 5 (median [interquartile range] 1 (0-3) in group S vs 1 [0-3] in group H; the difference in median [95% confidence interval] 0 [0, 0.5]; P = .34) were statistically similar in both the groups and the upper margin was within the predefined margin of 1. Incidence of surgical site infection (P = .46), postoperative hospital stay (P = .29), and days alive without antibiotic therapy at postoperative day 28 (P = .95) were similar in both groups.

CONCLUSION

High intraoperative fiO was noninferior to standard fiO in postoperative pulmonary complications in adult patients undergoing major surgery.

摘要

背景

尽管术中高氧治疗可能对手术部位感染有临床益处，但对术后呼吸功能的影响仍存在争议。然而，高浓度吸氧与肺保护性通气相结合是否会导致术后肺部并发症发生率增加，目前仍不清楚。

方法

在这项非劣效性随机试验中，将成人择期或急诊大手术患者术中高吸入氧分数（组 H）0.8 与标准吸入氧分数（组 S）0.3-0.4 进行比较。所有患者均采用肺保护性通气策略，包括潮气量 6-8ml/kg 预测体重、呼吸频率 12 次/分、呼气末正压 5-8cmH2O 的容量控制通气。术后第 3 天和第 5 天采用墨尔本组量表评估术后肺部并发症。

结果

本试验共纳入 226 例患者，其中 130 例行常规手术，96 例行急诊手术。患者中位数（四分位间距）为 48（35-58）岁，47.3%为女性。术后第 3 天（组 S 中位数[四分位间距]2[1-4]，组 H 中位数[2[1-3]；中位数差值[95%置信区间]0[0，-1]；P=.13）和第 5 天（组 S 中位数[四分位间距]1[0-3]，组 H 中位数[1[0-3]；中位数差值[95%置信区间]0[0，0.5]；P=.34）的墨尔本组评分在两组间差异无统计学意义，且上限在预设的 1 以内。两组间手术部位感染发生率（P=.46）、术后住院时间（P=.29）、术后第 28 天无抗生素治疗天数（P=.95）差异均无统计学意义。