The authors' affiliations are listed in the Appendix.
N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.
Whether noninvasive ventilation should be administered in patients with acute hypoxemic respiratory failure is debated. Therapy with high-flow oxygen through a nasal cannula may offer an alternative in patients with hypoxemia.
We performed a multicenter, open-label trial in which we randomly assigned patients without hypercapnia who had acute hypoxemic respiratory failure and a ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen of 300 mm Hg or less to high-flow oxygen therapy, standard oxygen therapy delivered through a face mask, or noninvasive positive-pressure ventilation. The primary outcome was the proportion of patients intubated at day 28; secondary outcomes included all-cause mortality in the intensive care unit and at 90 days and the number of ventilator-free days at day 28.
A total of 310 patients were included in the analyses. The intubation rate (primary outcome) was 38% (40 of 106 patients) in the high-flow-oxygen group, 47% (44 of 94) in the standard group, and 50% (55 of 110) in the noninvasive-ventilation group (P=0.18 for all comparisons). The number of ventilator-free days at day 28 was significantly higher in the high-flow-oxygen group (24±8 days, vs. 22±10 in the standard-oxygen group and 19±12 in the noninvasive-ventilation group; P=0.02 for all comparisons). The hazard ratio for death at 90 days was 2.01 (95% confidence interval [CI], 1.01 to 3.99) with standard oxygen versus high-flow oxygen (P=0.046) and 2.50 (95% CI, 1.31 to 4.78) with noninvasive ventilation versus high-flow oxygen (P=0.006).
In patients with nonhypercapnic acute hypoxemic respiratory failure, treatment with high-flow oxygen, standard oxygen, or noninvasive ventilation did not result in significantly different intubation rates. There was a significant difference in favor of high-flow oxygen in 90-day mortality. (Funded by the Programme Hospitalier de Recherche Clinique Interrégional 2010 of the French Ministry of Health; FLORALI ClinicalTrials.gov number, NCT01320384.).
对于急性低氧性呼吸衰竭患者，是否应采用无创通气存在争议。通过鼻导管给予高流量氧治疗可能为低氧血症患者提供另一种选择。
我们进行了一项多中心、开放标签试验，将无高碳酸血症的急性低氧性呼吸衰竭患者和动脉血氧分压与吸入氧分数比值为 300mmHg 或更低的患者随机分为高流量氧治疗组、标准面罩给氧组或无创正压通气组。主要结局为第 28 天插管患者的比例；次要结局包括重症监护病房和 90 天内的全因死亡率以及第 28 天无呼吸机天数。
共有 310 名患者纳入分析。高流量氧组的插管率（主要结局）为 38%（106 例患者中的 40 例），标准组为 47%（94 例患者中的 44 例），无创通气组为 50%（110 例患者中的 55 例）（所有比较的 P 值均为 0.18）。高流量氧组第 28 天无呼吸机天数显著较高（24±8 天，标准氧组为 22±10 天，无创通气组为 19±12 天；所有比较的 P 值均为 0.02）。标准氧与高流量氧相比，90 天死亡的危险比为 2.01（95%置信区间[CI]，1.01 至 3.99）（P=0.046），与无创通气相比，危险比为 2.50（95%CI，1.31 至 4.78）（P=0.006）。
对于非高碳酸血症性急性低氧性呼吸衰竭患者，高流量氧、标准氧或无创通气治疗并未导致插管率显著不同。高流量氧在 90 天死亡率方面具有显著优势。（由法国卫生部 2010 年医院临床研究区域间计划资助；FLORALI ClinicalTrials.gov 编号，NCT01320384。）
