NEJM:急性低氧性呼吸衰竭选择高流量或标准氧疗？

Abstract

Background

Data are needed on the effect of oxygen delivered through a high-flow nasal cannula, as compared with standard oxygen therapy, on intubation and mortality in patients with acute hypoxemic respiratory failure.

需要数据来评估经高流量鼻导管输送的氧气与标准氧疗相比，对急性低氧性呼吸衰竭患者的插管率和死亡率的影响。

Methods

In this multicenter, open-label trial, we randomly assigned patients who had acute hypoxemic respiratory failure to receive high-flow-oxygen or standard-oxygen therapy. All the patients had a ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen of 200 or less, a respiratory rate of more than 25 breaths per minute, and pulmonary infiltrate on chest imaging. The primary outcome was death by day 28.

在这项多中心、开放标签试验中，我们将急性低氧性呼吸衰竭患者随机分配接受高流量氧疗或标准氧疗。所有患者均符合以下条件：动脉血氧分压与吸入氧浓度的比值（PaO₂/FiO₂）≤200，呼吸频率>25次/分钟，胸部影像学检查显示肺部浸润。主要结局为第28天的死亡情况。

Results

A total of 1116 patients underwent randomization. Of these patients, 1110 (556 in the high-flow-oxygen group and 554 in the standard-oxygen group) were included in the analysis. Mortality at day 28 was 14.6% (in 81 of 556 patients) in the high-flow-oxygen group and 14.6% (in 81 of 554 patients) in the standard-oxygen group (difference, −0.05 percentage points; 95% confidence interval [CI], −4.21 to 4.10; P=0.98). The incidence of intubation by day 28 was 42.4% (in 236 of 556 patients) in the high-flow-oxygen group and 48.4% (in 268 of 554 patients) in the standard-oxygen group (difference, −5.93 percentage points; 95% CI, −11.78 to −0.08). Serious adverse events (cardiac arrest or pneumothorax) occurred during spontaneous breathing in 13 patients (2.3%) in the high-flow-oxygen group and in 6 patients (1.1%) in the standard-oxygen group.

共有1116名患者接受了随机分组。其中，1110名患者（高流量氧疗组556人，标准氧疗组554人）被纳入分析。高流量氧疗组第28天死亡率为14.6%（556人中81人死亡），标准氧疗组为14.6%（554人中81人死亡）（差异为−0.05个百分点；95%置信区间[CI]为−4.21至4.10；P=0.98）。高流量氧疗组第28天插管发生率为42.4%（556人中236人插管），标准氧疗组为48.4%（554人中268人插管）（差异为−5.93个百分点；95% CI为−11.78至−0.08）。在高流量氧疗组中，有13名患者（2.3%）在自主呼吸期间发生了严重不良事件（心脏骤停或气胸）；在标准氧疗组中，有6名患者（1.1%）发生此类事件。

Conclusions

Among patients with acute hypoxemic respiratory failure, the use of oxygen delivered through a high-flow nasal cannula did not significantly reduce mortality at day 28. (Funded by the French Ministry of Health and Fisher and Paykel Healthcare; SOHO ClinicalTrials.gov number, NCT04468126.)

在急性低氧性呼吸衰竭患者中，使用高流量鼻导管输送氧气并未显著降低第28天的死亡率。（由法国卫生部和Fisher and Paykel Healthcare资助；SOHO临床试验注册号：NCT04468126。）