ICM:VA-ECMO患者的保守或自由氧合目标

Abstract

Purpose: Patients receiving venoarterial extracorporeal membrane oxygenation (VA-ECMO) frequently develop arterial hyperoxaemia, which may be harmful. However, lower oxygen saturation targets may also lead to harmful episodes of hypoxaemia.

目的：接受静脉-动脉体外膜肺氧合（VA-ECMO）的患者经常发生动脉高氧血症，这可能是有害的。然而，较低的氧饱和度目标也可能导致有害的低氧血症发作。

Methods: In this registry-embedded, multicentre trial, we randomly assigned adult patients receiving VA-ECMO in an intensive care unit (ICU) to either a conservative (target SaO₂ 92-96%) or to a liberal oxygen strategy (target SaO₂ 97-100%) through controlled oxygen administration via the ventilator and ECMO gas blender. The primary outcome was the number of ICU-free days to day 28. Secondary outcomes included ICU-free days to day 60, mortality, ECMO and ventilation duration, ICU and hospital lengths of stay, and functional outcomes at 6 months.

方法：在这项嵌入注册的多中心试验中，我们将接受VA-ECMO治疗的成年患者在重症监护病房（ICU）随机分配到保守（目标SaO2 92-96%）或自由氧策略（目标SaO2 97-100%）组，通过呼吸机和ECMO气体混合器控制氧气给药。主要结果是第28天无ICU天数。次要结果包括第60天无ICU天数、死亡率、ECMO和通气持续时间、ICU和医院住院时间，以及6个月时的功能结果。

Results: From September 2019 through June 2023, 934 patients who received VA-ECMO were reported to the EXCEL registry, of whom 300 (192 cardiogenic shock, 108 refractory cardiac arrest) were recruited. We randomised 149 to a conservative and 151 to a liberal oxygen strategy. The median number of ICU-free days to day 28 was similar in both groups (conservative: 0 days [interquartile range (IQR) 0-13.7] versus liberal: 0 days [IQR 0-13.7], median treatment effect: 0 days [95% confidence interval (CI) – 3.1 to 3.1]). Mortality at day 28 (59/159 [39.6%] vs 59/151 [39.1%]) and at day 60 (64/149 [43%] vs 62/151 [41.1%] were similar in conservative and liberal groups, as were all other secondary outcomes and adverse events. The conservative group experienced 44 (29.5%) major protocol deviations compared to 2 (1.3%) in the liberal oxygen group (P < 0.001).

结果：从2019年9月至2023年6月，共有934名接受VA-ECMO治疗的患者报告给EXCEL注册，其中300名（192名心源性休克，108名难治性心脏骤停）被招募。我们将149名随机分配到保守组，151名分配到自由氧策略组。两组第28天无ICU天数的中位数相似（保守组：0天[四分位数范围（IQR）0-13.7]与自由组：0天[IQR 0-13.7]，中位数治疗效果：0天[95%置信区间（CI）-3.1至3.1]）。第28天（59/159 [39.6%] vs 59/151 [39.1%]）和第60天（64/149 [43%] vs 62/151 [41.1%]）的死亡率在保守组和自由组相似，所有其他次要结果和不良事件也是如此。保守组经历了44次（29.5%）主要协议偏差，而自由氧组仅有2次（1.3%）（P < 0.001）。

Conclusions: In adults receiving VA-ECMO in ICU, a conservative compared to a liberal oxygen strategy, did not affect the number of ICU-free days to day 28.

结论：在接受ICU VA-ECMO治疗的成年患者中，保守与自由氧策略相比，不影响第28天无ICU天数。