本文由小咖机器人翻译整理

期刊来源：JAMA

原文链接：https://doi.org/10.1001/jama.2024.2934

摘要内容如下：

重要性

补充氧气广泛用于COVID-19和严重低氧血症患者，但较低剂量可能有益。

目的

评估重症监护室（ICU）中COVID-19和严重低氧血症患者的目标PaO2为60 mm Hg与90 mm Hg的效果。

设计、设置和参与者

从2020年8月至2023年3月，在欧洲的11个ICU中进行了多中心随机临床试验，包括726名接受至少10 L/min氧气或机械通气的COVID-19成人。由于招募缓慢，该试验在结果评估前提前终止。90天随访于2023年6月1日结束。

干预措施

患者按1:1的比例随机分配到PaO2为60 mm Hg的组（低氧合组；N=365）或90 mm Hg（较高氧合组；N=361）在ICU中长达90天。

主要成果和措施

主要转归是90天时无生命支持（机械通气、循环支持或肾脏替代治疗）的存活天数。次要转归包括90天时的死亡率、发生严重不良事件的患者比例、存活天数和出院天数。

结果

在726例随机分组的患者中，697例（低氧合组351例，高氧合组346例）的主要结果数据可用。中位年龄为66岁，495名患者（68%）为男性。在90天时，没有生命支持的中位存活天数在低氧合组为80.0天（IQR，9.0-89.0天），在高氧合组为72.0天（IQR，2.0-88.0天）（通过van Elteren检验，P=0.009；补充自举调整均数差，5.8天[95%CI，0.2-11.5天]；P=.04）。低氧合组90天死亡率为30.2%，高氧合组为34.7%（风险比，0.86[98.6%CI，0.66-1.13]；P=.18）。发生严重不良事件的患者比例、存活天数和出院天数在统计学上无显著差异。

结论和相关性

在患有COVID-19和严重低氧血症的成人ICU患者中，以60 mm Hg的PaO2为目标，比以90 mm Hg的PaO2为目标，在90天内无生命支持的存活天数更多。

试用注册

ClinicalTrials.gov标识符：NCT04425031。

英文原文如下：

Abstracts

Importance  Supplemental oxygen is ubiquitously used in patients with COVID-19 and severe hypoxemia, but a lower dose may be beneficial.

Objective  To assess the effects of targeting a Pao2 of 60 mm Hg vs 90 mm Hg in patients with COVID-19 and severe hypoxemia in the intensive care unit (ICU).

Design, Setting, and Participants  Multicenter randomized clinical trial including 726 adults with COVID-19 receiving at least 10 L/min of oxygen or mechanical ventilation in 11 ICUs in Europe from August 2020 to March 2023. The trial was prematurely stopped prior to outcome assessment due to slow enrollment. End of 90-day follow-up was June 1, 2023.

Interventions  Patients were randomized 1:1 to a Pao2 of 60 mm Hg (lower oxygenation group; n = 365) or 90 mm Hg (higher oxygenation group; n = 361) for up to 90 days in the ICU.

Main Outcomes and Measures  The primary outcome was the number of days alive without life support (mechanical ventilation, circulatory support, or kidney replacement therapy) at 90 days. Secondary outcomes included mortality, proportion of patients with serious adverse events, and number of days alive and out of hospital, all at 90 days.

Results  Of 726 randomized patients, primary outcome data were available for 697 (351 in the lower oxygenation group and 346 in the higher oxygenation group). Median age was 66 years, and 495 patients (68%) were male. At 90 days, the median number of days alive without life support was 80.0 days (IQR, 9.0-89.0 days) in the lower oxygenation group and 72.0 days (IQR, 2.0-88.0 days) in the higher oxygenation group (P = .009 by van Elteren test; supplemental bootstrapped adjusted mean difference, 5.8 days [95% CI, 0.2-11.5 days]; P = .04). Mortality at 90 days was 30.2% in the lower oxygenation group and 34.7% in the higher oxygenation group (risk ratio, 0.86 [98.6% CI, 0.66-1.13]; P = .18). There were no statistically significant differences in proportion of patients with serious adverse events or in number of days alive and out of hospital.

Conclusion and Relevance  In adult ICU patients with COVID-19 and severe hypoxemia, targeting a Pao2 of 60 mm Hg resulted in more days alive without life support in 90 days than targeting a Pao2 of 90 mm Hg.

Trial Registration  ClinicalTrials.gov Identifier: NCT04425031.

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