Section of Anaesthetics, Pain Medicine, and Intensive Care, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, United Kingdom.
Children's Acute Transport Service, Great Ormond Street Hospital for Children NHS Foundation Trust, London, United Kingdom.
JAMA. 2022 Apr 26;327(16):1555-1565. doi: 10.1001/jama.2022.3367.
The optimal first-line mode of noninvasive respiratory support following extubation of critically ill children is not known.
To evaluate the noninferiority of high-flow nasal cannula (HFNC) therapy as the first-line mode of noninvasive respiratory support following extubation, compared with continuous positive airway pressure (CPAP), on time to liberation from respiratory support.
DESIGN, SETTING, AND PARTICIPANTS: This was a pragmatic, multicenter, randomized, noninferiority trial conducted at 22 pediatric intensive care units in the United Kingdom. Six hundred children aged 0 to 15 years clinically assessed to require noninvasive respiratory support within 72 hours of extubation were recruited between August 8, 2019, and May 18, 2020, with last follow-up completed on November 22, 2020.
Patients were randomized 1:1 to start either HFNC at a flow rate based on patient weight (n = 299) or CPAP of 7 to 8 cm H2O (n = 301).
The primary outcome was time from randomization to liberation from respiratory support, defined as the start of a 48-hour period during which the child was free from all forms of respiratory support (invasive or noninvasive), assessed against a noninferiority margin of an adjusted hazard ratio (HR) of 0.75. There were 6 secondary outcomes, including mortality at day 180 and reintubation within 48 hours.
Of the 600 children who were randomized, 553 children (HFNC, 281; CPAP, 272) were included in the primary analysis (median age, 3 months; 241 girls [44%]). HFNC failed to meet noninferiority, with a median time to liberation of 50.5 hours (95% CI, 43.0-67.9) vs 42.9 hours (95% CI, 30.5-48.2) for CPAP (adjusted HR, 0.83; 1-sided 97.5% CI, 0.70-∞). Similar results were seen across prespecified subgroups. Of the 6 prespecified secondary outcomes, 5 showed no significant difference, including the rate of reintubation within 48 hours (13.3% for HFNC vs 11.5 % for CPAP). Mortality at day 180 was significantly higher for HFNC (5.6% vs 2.4% for CPAP; adjusted odds ratio, 3.07 [95% CI, 1.1-8.8]). The most common adverse events were abdominal distension (HFNC: 8/281 [2.8%] vs CPAP: 7/272 [2.6%]) and nasal/facial trauma (HFNC: 14/281 [5.0%] vs CPAP: 15/272 [5.5%]).
Among critically ill children requiring noninvasive respiratory support following extubation, HFNC compared with CPAP following extubation failed to meet the criterion for noninferiority for time to liberation from respiratory support.
isrctn.org Identifier: ISRCTN60048867.
目前尚不清楚危重病患儿拔管后首选的无创性呼吸支持模式。
评估与持续气道正压通气（CPAP）相比，高流量鼻导管（HFNC）治疗作为拔管后无创性呼吸支持的一线治疗方式，在脱离呼吸支持的时间方面是否不劣于 CPAP。
设计、地点和参与者：这是一项在英国 22 家儿科重症监护病房进行的实用性、多中心、随机、非劣效性试验。2019 年 8 月 8 日至 2020 年 5 月 18 日期间，招募了 600 名年龄在 0 至 15 岁之间、临床评估需要在拔管后 72 小时内接受无创性呼吸支持的患儿，最后一次随访于 2020 年 11 月 22 日完成。
患者以 1:1 的比例随机分为两组，一组接受基于患者体重的 HFNC 治疗（n=299），另一组接受 CPAP 治疗（7-8cmH2O，n=301）。
主要结局是从随机分组到脱离呼吸支持的时间，定义为开始 48 小时期间，患儿无任何形式的呼吸支持（有创或无创），与调整后的危险比（HR）非劣效性边界 0.75 进行比较。有 6 个次要结局，包括第 180 天的死亡率和 48 小时内再次插管。
在随机分配的 600 名患儿中，553 名患儿（HFNC 组 281 例，CPAP 组 272 例）被纳入主要分析（中位年龄 3 个月，241 名女孩[44%]）。HFNC 未能达到非劣效性标准，其脱离呼吸支持的中位时间为 50.5 小时（95%CI，43.0-67.9），CPAP 组为 42.9 小时（95%CI，30.5-48.2）（调整后的 HR，0.83；单侧 97.5%CI，0.70-∞）。在预先指定的亚组中也观察到了类似的结果。在 6 个预先指定的次要结局中，有 5 个没有显著差异，包括 48 小时内再次插管的发生率（HFNC 组为 13.3%，CPAP 组为 11.5%）。HFNC 组第 180 天的死亡率显著更高（5.6%vs CPAP 组 2.4%；调整后的比值比，3.07[95%CI，1.1-8.8]）。最常见的不良事件是腹部膨胀（HFNC 组：8/281[2.8%]vs CPAP 组：7/272[2.6%]）和鼻/面部创伤（HFNC 组：14/281[5.0%]vs CPAP 组：15/272[5.5%]）。
在需要拔管后无创性呼吸支持的危重病患儿中，与 CPAP 相比，HFNC 作为拔管后的一线治疗方法，在脱离呼吸支持的时间方面不劣效。
isrctn.org 标识符：ISRCTN60048867。
