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术中高吸入氧分数并不会增加术后呼吸并发症的风险:交替干预临床试验。

Intra-operative high inspired oxygen fraction does not increase the risk of postoperative respiratory complications: Alternating intervention clinical trial.

出版信息

Eur J Anaesthesiol. 2019 May;36(5):320-326. doi: 10.1097/EJA.0000000000000980.

Abstract

BACKGROUND

The WHO recommends routine intra-operative and early postoperative use of high inspired oxygen concentrations (hyperoxia). However, a high intra-operative inspired oxygen fraction (FiO2) might result in an increased risk of postoperative respiratory complications.

AIM

To test the hypothesis that intra-operative FiO2 of 80% compared with 30% inspired oxygen decreases the postoperative ratio of arterial saturation to fraction of inspired oxygen (SpO2/FiO2). Secondarily, to evaluate whether an intra-operative inspired FiO2 of 80% increases the incidence of pulmonary complications.

DESIGN

Posthoc subanalysis of a large alternating cohort trial.

SETTING

Cleveland Clinic, Cleveland, United States, from 2013 to 2016.

PATIENTS

Adults having colorectal surgery. Cases lasting less than 2 h, re-operations on the same hospitalisation, and cases with missing intra-operative or postoperative data were excluded.

INTERVENTION

Maintaining intra-operative FiO2 at 30 or 80% and alternating this management every 2 weeks for a study period of 39 months.

MAIN OUTCOME

Minimal SpO2/FiO2 ratio value in the postanaesthesia care unit. Secondary outcome was a composite of postoperative pulmonary complications throughout hospitalisation.

RESULTS

A total of 5056 patients were included. Groups were well balanced on all demographic, baseline and procedural variables. Median time-weighted averages of intra-operative FiO2 in the 30 and 80% groups were 43% (IQR 38 to 54%, N=2486) and 81% (IQR 78 to 82%, N=2570), respectively. No difference was found in the lowest SpO2/FiO2 ratio (estimated median difference 0 [95% confidence interval: 0, 0], P = 0.91). The incidence of postoperative pulmonary complications was 16.3 and 17.6% in the 30 and 80% FiO2 groups, respectively (relative risk 1.07 [95% confidence interval: 0.95, 1.21], P = 0.25).

CONCLUSION

Intra-operative hyperoxia did not change the postoperative SpO2/FiO2 ratio or the risk for pulmonary complications. Clinicians should not refrain from using hyperoxia for fear of provoking respiratory complications.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT01777568.

摘要

背景

世界卫生组织(WHO)建议在术中及术后早期常规使用高吸入氧浓度(高氧)。然而,术中高吸入氧分数(FiO2)可能会增加术后呼吸并发症的风险。

目的

检验假设,即与吸入氧分数 30%相比,术中吸入氧分数 80%是否会降低术后动脉血氧饱和度与吸入氧分数的比值(SpO2/FiO2)。其次,评估术中吸入氧分数 80%是否会增加肺部并发症的发生率。

设计

大型交替队列试验的事后亚分析。

地点

美国克利夫兰克利夫兰诊所,2013 年至 2016 年。

患者

行结直肠手术的成年人。排除持续时间少于 2 小时、同一住院期间再次手术以及术中或术后数据缺失的病例。

干预

在 39 个月的研究期间,将术中 FiO2维持在 30%或 80%,并每两周交替进行此管理。

主要结局

麻醉后护理单元中最小的 SpO2/FiO2 比值。次要结局是整个住院期间的术后肺部并发症的综合结果。

结果

共纳入 5056 例患者。两组在所有人口统计学、基线和手术变量方面均平衡良好。术中 FiO2 的时间加权平均值在 30%和 80%组分别为 43%(IQR 38 至 54%,N=2486)和 81%(IQR 78 至 82%,N=2570)。最低 SpO2/FiO2 比值无差异(估计中位数差值 0[95%置信区间:0,0],P=0.91)。30%FiO2 组和 80%FiO2 组术后肺部并发症发生率分别为 16.3%和 17.6%(相对风险 1.07[95%置信区间:0.95,1.21],P=0.25)。

结论

术中高氧并未改变术后 SpO2/FiO2 比值或肺部并发症的风险。临床医生不应因担心引发呼吸并发症而避免使用高氧。

临床试验注册

ClinicalTrials.gov 标识符:NCT01777568。

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