High-Flow or Standard Oxygen in Acute Hypoxemic Respiratory Failure.

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.

在这项多中心、开放标签试验中，我们随机分配了患有急性低氧性呼吸衰竭的患者，接受高流量氧疗或标准氧疗。

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.

所有患者的动脉氧分压与吸入氧分数比值均≤200，呼吸频率超过每分钟25次，胸部影像学显示肺部浸润。

The primary outcome was death by day 28.

主要结果指标是第28天的死亡情况。

Results

A total of 1116 patients underwent randomization.

共有1116名患者进行了随机分组。

Of these patients, 1110 (556 in the high-flow-oxygen group and 554 in the standard-oxygen group) were included in the analysis.

在这些患者中，1110名（高流量氧组556名和标准氧组554名）被纳入分析。

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).

在第28天，高流量氧疗组的死亡率为14.6%（556名患者中有81名），标准氧疗组的死亡率为14.6%（554名患者中有81名）（差异，-0.05个百分点；95%置信区间[CI]，-4.21至4.10；P = 0.98）。

The incidenceof 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).

在第28天，高流量氧疗组的插管发生率为42.4%（556名患者中有236名），标准氧疗组的插管发生率为48.4%（554名患者中有268名）（差异，-5.93个百分点；95%置信区间[CI]，-11.78至-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.

在接受高流量氧疗的患者中，有13名（2.3%）在自主呼吸期间出现了严重不良事件（心脏骤停或气胸），而在接受标准氧疗的患者中，有6名（1.1%）出现了此类事件。

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.

在急性低氧性呼吸衰竭患者中，使用高流量鼻导管供氧并未显著降低第28天的死亡率。

(Funded by the French Ministry of Health and Fisher and Paykel Healthcare; SOHO ClinicalTrials.gov number, NCT04468126.).

(由法国卫生部和Fisher and Paykel Healthcare资助; SOHO ClinicalTrials.gov编号, NCT04468126.)