Although cumulative studies have demonstrated a beneficial effect of high-flow nasal cannula oxygen (HFNC) in acute hypercapnic respiratory failure, randomized trials to compare HFNC with non-invasive ventilation (NIV) as initial treatment in acute exacerbations of chronic obstructive pulmonary disease (AECOPD) patients with acute-moderate hypercapnic respiratory failure are limited. The aim of this randomized, open label, non-inferiority trial was to compare treatment failure rates between HFNC and NIV in such patients. Patients diagnosed with AECOPD with a baseline arterial blood gas pH between 7.25 and 7.35 and PaCO2 ≥ 50 mmHg admitted to two intensive care units (ICUs) at a large tertiary academic teaching hospital between March 2018 and December 2022 were randomly assigned to HFNC or NIV. The primary endpoint was the rate of treatment failure, defined as endotracheal intubation or a switch to the other study treatment modality. Secondary endpoints were rates of intubation or treatment change, blood gas values, vital signs at one, 12, and 48 h, 28-day mortality, as well as ICU and hospital lengths of stay. 225 total patients (113 in the HFNC group and 112 in the NIV group) were included in the intention-to-treat analysis. The failure rate of the HFNC group was 25.7%, while the NIV group was 14.3%. The failure rate risk difference between the two groups was 11.38% (95% CI 0.25–21.20, P = 0.033), which was higher than the non-inferiority cut-off of 9%. In the per-protocol analysis, treatment failure occurred in 28 of 110 patients (25.5%) in the HFNC group and 15 of 109 patients (13.8%) in the NIV group (risk difference, 11.69%; 95% CI 0.48–22.60). The intubation rate in the HFNC group was higher than in the NIV group (14.2% vs 5.4%, P = 0.026). The treatment switch rate, ICU and hospital length of stay or 28-day mortality in the HFNC group were not statistically different from the NIV group (all P > 0.05). HFNC was not shown to be non-inferior to NIV and resulted in a higher incidence of treatment failure than NIV when used as the initial respiratory support for AECOPD patients with acute-moderate hypercapnic respiratory failure. Trial registration: chictr.org (ChiCTR1800014553). Registered 21 January 2018, http://www.chictr.org.cn

中文翻译：

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高流量鼻插管氧疗与无创通气治疗慢性阻塞性肺疾病急性加重伴急性至中度高碳酸血症性呼吸衰竭的疗效：一项随机对照非劣效性试验


尽管累积研究表明高流量鼻插管氧 （HFNC） 对急性高碳酸血症性呼吸衰竭有益，但比较 HFNC 与无创通气 （NIV） 作为急性加重慢性阻塞性肺病 （AECOPD） 急性加重患者急性加重的急性发作急性期的随机试验是有限的急性-中度高碳酸血症性呼吸衰竭。这项随机、开放标签、非劣效性试验的目的是比较此类患者 HFNC 和 NIV 的治疗失败率。2018 年 3 月至 2022 年 12 月期间，一家大型三级学术教学医院的两个重症监护病房 （ICU） 收治的基线动脉血气 pH 值在 7.25 至 7.35 之间且 PaCO2 ≥ 50 mmHg 的 AECOPD 患者被随机分配到 HFNC 或 NIV。主要终点是治疗失败率，定义为气管插管或改用其他研究治疗方式。次要终点是插管或治疗改变率、血气值、1 小时、12 小时和 48 小时生命体征、28 天死亡率以及 ICU 和住院时间。意向治疗分析共纳入 225 例患者 （HFNC 组 113 例，NIV 组 112 例）。HFNC 组失败率为 25.7%，而 NIV 组为 14.3%。两组之间的失败率风险差异为 11.38% （95% CI 0.25–21.20，P = 0.033），高于 9% 的非劣效性临界值。在符合方案的分析中，HFNC 组 110 例患者中有 28 例 （25.5%） 发生治疗失败，NIV 组 109 例患者中有 15 例 （13.8%） 发生治疗失败（风险差，11.69%;95% CI 0.48-22.60）。HFNC 组的插管率高于 NIV 组 （14.2% vs 5.4%，P = 0.026）。 HFNC 组的治疗转换率、ICU 和住院时间或 28 d 死亡率与 NIV 组差异无统计学意义 （均 P > 0.05）。HFNC 未被证明不劣于 NIV，并且在用作急性至中度高碳酸血症性呼吸衰竭 AECOPD 患者的初始呼吸支持时，导致治疗失败的发生率高于 NIV。试验注册：chictr.org （ChiCTR1800014553）。2018 年 1 月 21 日注册，http://www.chictr.org。快递 之 家