英国伦敦帝国理工学院Padmanabhan Ramnarayan团队研究了高流量鼻导管治疗与持续气道正压治疗对儿科危重病房收治的重症儿童摆脱呼吸支持的效果。这一研究成果发表在2022年6月16日出版的《美国医学会杂志》上。

急性患儿的最佳一线无创呼吸支持模式尚不清楚。

为了评估高流量鼻导管疗法（HFNC）作为急性疾病无创呼吸支持一线模式，与持续气道正压通气（CPAP）相比，从各种形式的呼吸支持中解脱出来的非劣效性，研究组在英国24个儿科重症监护室进行了一项实用、多中心、随机非劣效性临床试验，2019年8月至2021年11月招募了600名年龄在0至15岁、临床评估为需要无创呼吸支持的急性患儿，最后一次随访于2022年3月完成。

将患者按1：1随机分组，301例基于患儿体重确定HFNC的流速，299例接受7-8 cm H₂O的CPAP。主要结局是从随机分组到脱离呼吸支持的时间，定义为48小时内参与者脱离所有形式的呼吸支持（有创或无创）的开始时间，对照校正后危险比0.75为非劣效性边缘。还评估了7项次要结局，包括重症监护病房出院时的死亡率、48小时内插管和镇静剂的使用。

在600名随机儿童中，5名（HFNC组1名；CPAP组4名）未获得知情同意，22名（HFNC组5名；CPAP组17名）未开始呼吸支持；573名儿童（HFNC组295名；CPAP组278名）被纳入主要分析（中位年龄9个月；226名为女孩[39%）。

HFNC组的中位脱离呼吸支持时间为52.9小时，CPAP组为47.9小时，绝对差异为5.0小时。这符合非劣效性标准。在7个预先指定的次要结局中，HFNC组有3个显著降低：镇静剂的使用（分别为27.7%对37%）；重症监护平均住院时间（分别为5天与7.4天）；急性住院的平均持续时间（分别为13.8天与19.5天）。最常见的不良事件是鼻外伤（HFNC组发生率为2.0%；CPAP组为6.5%）。

研究结果表明，对于临床评估需要在儿科重症监护室进行无创呼吸支持的急性患儿，HFNC与CPAP相比，从呼吸支持中解脱出来的时间符合非劣效性标准。

附：英文原文

Title: Effect of High-Flow Nasal Cannula Therapy vs Continuous Positive Airway Pressure Therapy on Liberation From Respiratory Support in Acutely Ill Children Admitted to Pediatric Critical Care Units: A Randomized Clinical Trial

Author: Padmanabhan Ramnarayan, Alvin Richards-Belle, Laura Drikite, Michelle Saull, Izabella Orzechowska, Robert Darnell, Zia Sadique, Julie Lester, Kevin P. Morris, Lyvonne N. Tume, Peter J. Davis, Mark J. Peters, Richard G. Feltbower, Richard Grieve, Karen Thomas, Paul R. Mouncey, David A. Harrison, Kathryn M. Rowan, FIRST-ABC Step-Up RCT Investigators and the Paediatric Critical Care Society Study Group, Nazima Pathan, Deborah K White, Esther S Daubney, Nayan Shetty, Jones Dawn, OMalley Laura, Rad Laura, Peter Davis, Frances Hutchings, Karen Coy, Sarah Sheedy, Alice Bowerman, Kerry Mahoney, Laura Dodge, Helen Raeside, Pardina Samson-Fessale, Kribashnie Nundlall, Jaime Carungcong, Aravind S Kashyap, Christine Mackerness, Sarah E Daggert, Rob Claydon, Kirsty Mulgrew, Mark J Peters, Ana L Pereira Tomas, Holly Belfield, Lauran ONeill Gutierrez, Hamza Meghari, Emily Beech, Gareth Jones, Samiran Ray, Saxena Rohit, Hilary Klonin, Remy Toko, Melony Bowdler-Hayes, Leanne Sherris, Arshid Murad, Armstrong Sonia, Hebbron Kerry, Szekeres Adele, Avishay Sarfatti, Zoe Oliver, Sarah Barton, Melanie James, Lynda Verhulst, Ivan Carlo Caro, Akash Deep, Bedangshu Saikia, Samira Neshat, Rekha Patel, Seema Sukhani, Karen Samm, Benila Ravindranathan, Vanessa Zammit, Meleika Hamilton

Issue&Volume: 2022-06-16

Abstract:

Importance  The optimal first-line mode of noninvasive respiratory support for acutely ill children is not known.

Objective  To evaluate the noninferiority of high-flow nasal cannula therapy (HFNC) as the first-line mode of noninvasive respiratory support for acute illness, compared with continuous positive airway pressure (CPAP), for time to liberation from all forms of respiratory support.

Design, Setting, and Participants  Pragmatic, multicenter, randomized noninferiority clinical trial conducted in 24 pediatric critical care units in the United Kingdom among 600 acutely ill children aged 0 to 15 years who were clinically assessed to require noninvasive respiratory support, recruited between August 2019 and November 2021, with last follow-up completed in March 2022.

Interventions  Patients were randomized 1:1 to commence either HFNC at a flow rate based on patient weight (n=301) or CPAP of 7 to 8 cm H2O (n=299).

Main Outcomes and Measures  The primary outcome was time from randomization to liberation from respiratory support, defined as the start of a 48-hour period during which a participant was free from all forms of respiratory support (invasive or noninvasive), assessed against a noninferiority margin of an adjusted hazard ratio of 0.75. Seven secondary outcomes were assessed, including mortality at critical care unit discharge, intubation within 48 hours, and use of sedation.

Results  Of the 600 randomized children, consent was not obtained for 5 (HFNC: 1; CPAP: 4) and respiratory support was not started in 22 (HFNC: 5; CPAP: 17); 573 children (HFNC: 295; CPAP: 278) were included in the primary analysis (median age, 9 months; 226 girls [39%]). The median time to liberation in the HFNC group was 52.9 hours (95% CI, 46.0-60.9 hours) vs 47.9 hours (95% CI, 40.5-55.7 hours) in the CPAP group (absolute difference, 5.0 hours [95% CI –10.1 to 17.4 hours]; adjusted hazard ratio 1.03 [1-sided 97.5% CI, 0.86-∞]). This met the criterion for noninferiority. Of the 7 prespecified secondary outcomes, 3 were significantly lower in the HFNC group: use of sedation (27.7% vs 37%; adjusted odds ratio, 0.59 [95% CI, 0.39-0.88]); mean duration of critical care stay (5 days vs 7.4 days; adjusted mean difference, 3 days [95% CI, 5.1 to 1 days]); and mean duration of acute hospital stay (13.8 days vs 19.5 days; adjusted mean difference, 7.6 days [95% CI, 13.2 to 1.9 days]). The most common adverse event was nasal trauma (HFNC: 6/295 [2.0%]; CPAP: 18/278 [6.5%]).

Conclusions and Relevance  Among acutely ill children clinically assessed to require noninvasive respiratory support in a pediatric critical care unit, HFNC compared with CPAP met the criterion for noninferiority for time to liberation from respiratory support.

DOI: 10.1001/jama.2022.9615

Source: https://jamanetwork.com/journals/jama/fullarticle/2793546