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拔管后持续气道正压通气对危重患儿脱离呼吸支持的影响。相关论文于2022年4月7日发表在《美国医学会杂志》上。

危重患儿拔管后无创呼吸支持的最佳一线模式尚不清楚。

为了评估与持续气道正压通气（CPAP）相比，高流量鼻导管（HFNC）作为拔管后无创呼吸支持的一线模式，及时脱离呼吸支持的非劣效性，研究组在英国的22个儿科重症监护病房进行了一项务实、多中心、随机、非劣效性试验。

2019年8月8日至2020年5月18日，研究组招募了600名经临床评估需要在拔管72小时内进行无创呼吸支持的0至15岁儿童，最后一次随访于2020年11月22日完成。将患者以1：1的比例随机分组，分别根据患者体重接受HFNC（299名）或7-8cm水的CPAP（301名)。

主要结局是从随机分组到从脱离呼吸支持的时间，定义为48小时周期起始，且在此期间患儿没有任何形式的呼吸支持（有创或无创），校正后的危险比（HR）非劣效性范围为0.75。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600名随机分组的患儿中，553名患儿（HFNC组281名；CPAP组272名）被纳入主要分析（中位年龄3个月；241名[44%]为女孩）。HFNC组的中位脱机时间为50.5小时，CPAP组为42.9小时，校正后的HR为0.83，未能达到非劣效性。在预先指定的亚组中也观察到类似的结果。

在6项预先确定的次要结局中，5项无显著差异，包括48小时内再次插管率（HFNC组为13.3%，CPAP组为11.5%）。HFNC组在第180天的死亡率为5.6%，显著高于CPAP组的2.4%，校正后的优势比为3.07。最常见的不良事件是腹胀（HFNC组2.8% vs CPAP组2.6%）和鼻/面部创伤（HFNC组5.0% vs CPAP组5.5%）。

研究结果表明，对于拔管后需要无创呼吸支持的危重患儿，HFNC与拔管后CPAP相比，未能满足及时脱离呼吸支持的非劣效性标准。

附：英文原文

Title: Effect of High-Flow Nasal Cannula Therapy vs Continuous Positive Airway Pressure Following Extubation on Liberation From Respiratory Support in Critically Ill Children: 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-Down RCT Investigators and the Paediatric Critical Care Society Study Group, Nazima Pathan, Esther Daubney, Deborah White, Nayan Shetty, Dawn Jones, Laura Rad, Laura OMalley, Kevin Morris, Sarah Fox, Carly Tooke, Afeda Mohamed Ali, Peter Davis, Helen Marley, Rebecca Lean, Laura Dodge, Angela Aramburo, Laura Alcantara, Laura Tos, Helena Sampaio, Siva Oruganti, Susan Bowes, Awen Hughes, Mark J Peters, Lauran ONeill, Holly Belfield, Samiran Ray, Rohit Saxena, Helen Vander Johnson, Tara McHugh, Gareth Jones, David Armstrong, Laura Fraser, Margrethe Van Dijke, Ian Piper, Jon Lillie, Paul A Wellman, Aleksandra Williams, Tabitha Craen, Joanne Perkins, Christine Mackerness, Aravind Kashyap, Lindsay Cooper, Angela Lawton, Lynda Verhulst, Akash Deep, Ivan C Caro, Eniola Nsirim, Samira N Vahid, Bedangshu Saikia, Rekha Patel, Graham Mason, Claire Jennings, Rebecca Marshall, Danielle Pask, Avishay Sarfatti

Issue&Volume: 2022-04-07

Abstract:

Importance  The optimal first-line mode of noninvasive respiratory support following extubation of critically ill children is not known.

Objective  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.

Interventions  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).

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 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.

Results  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%]).

Conclusions and Relevance  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.

DOI: 10.1001/jama.2022.3367

Source: https://jamanetwork.com/journals/jama/fullarticle/2791014