{"id":22651,"date":"2022-10-17T04:45:00","date_gmt":"2022-10-16T20:45:00","guid":{"rendered":"http:\/\/csccm.org.cn\/?p=22651"},"modified":"2022-10-17T08:27:02","modified_gmt":"2022-10-17T00:27:02","slug":"jama%e5%8f%91%e8%a1%a8%e8%ae%ba%e6%96%87%ef%bc%9a%e7%bb%8f%e5%a4%b4%e7%9b%94%e8%a1%8c%e6%97%a0%e5%88%9b%e9%80%9a%e6%b0%94%e4%b8%8e%e5%b8%b8%e8%a7%84%e5%91%bc%e5%90%b8%e6%94%af%e6%8c%81%e5%af%b9","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=22651","title":{"rendered":"[JAMA\u53d1\u8868\u8bba\u6587]\uff1a\u7ecf\u5934\u76d4\u884c\u65e0\u521b\u901a\u6c14\u4e0e\u5e38\u89c4\u547c\u5438\u652f\u6301\u5bf9\u65b0\u51a0\u80ba\u708e\u4f34\u6025\u6027\u7f3a\u6c27\u6027\u547c\u5438\u529f\u80fd\u8870\u7aed\u60a3\u8005\u7684\u5f71\u54cd"},"content":{"rendered":"\n<p>Original Investigation&nbsp;<\/p>\n\n\n\n<p>September&nbsp;20,&nbsp;2022<\/p>\n\n\n\n<h1 class=\"wp-block-heading\">Effect of Helmet Noninvasive Ventilation vs Usual Respiratory Support on Mortality Among Patients With Acute Hypoxemic Respiratory Failure Due to COVID-19: The HELMET-COVID Randomized Clinical Trial<\/h1>\n\n\n\n<h3 class=\"wp-block-heading\">Yaseen M.\u00a0Arabi,\u00a0Sara\u00a0Aldekhyl,\u00a0Saad\u00a0Al Qahtani,\u00a0et al<\/h3>\n\n\n\n<h3 class=\"wp-block-heading\"><em>JAMA.\u00a0<\/em>2022;328(11):1063-1072. doi:10.1001\/jama.2022.15599<\/h3>\n\n\n\n<p>Key Points<\/p>\n\n\n\n<p><strong>Question<\/strong>&nbsp;&nbsp;What is the effect of noninvasive ventilation delivered by helmet compared with usual respiratory support (mask noninvasive ventilation, high-flow nasal oxygen, and standard oxygen) on the risk of mortality among adults with acute hypoxemic respiratory failure due to COVID-19?<\/p>\n\n\n\n<p><strong>Findings<\/strong>&nbsp;&nbsp;In this randomized clinical trial that included 320 adults with acute hypoxemic respiratory failure related to COVID-19, randomization to helmet use compared with usual respiratory support resulted in mortality within 28 days in 27.0% vs 26.1%, respectively. This difference was not statistically significant.<\/p>\n\n\n\n<p><strong>Meaning<\/strong>&nbsp;&nbsp;Helmet noninvasive ventilation did not significantly reduce 28-day mortality compared with usual respiratory support among patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia; however, interpretation of the findings is limited by imprecision in the effect size estimate.<a><\/a><\/p>\n\n\n\n<p>Abstract<\/p>\n\n\n\n<p><strong>Importance<\/strong>&nbsp;&nbsp;Helmet noninvasive ventilation has been used in patients with COVID-19 with the premise that helmet interface is more effective than mask interface in delivering prolonged treatments with high positive airway pressure, but data about its effectiveness are limited.<\/p>\n\n\n\n<p><strong>Objective<\/strong>&nbsp;&nbsp;To evaluate whether helmet noninvasive ventilation compared with usual respiratory support reduces mortality in patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia.<\/p>\n\n\n\n<p><strong>Design, Setting, and Participants<\/strong>&nbsp;&nbsp;This was a multicenter, pragmatic, randomized clinical trial that was conducted in 8 sites in Saudi Arabia and Kuwait between February 8, 2021, and November 16, 2021. Adult patients with acute hypoxemic respiratory failure (n\u2009=\u2009320) due to suspected or confirmed COVID-19 were included. The final follow-up date for the primary outcome was December 14, 2021.<\/p>\n\n\n\n<p><strong>Interventions<\/strong>&nbsp;&nbsp;Patients were randomized to receive helmet noninvasive ventilation (n\u2009=\u2009159) or usual respiratory support (n\u2009=\u2009161), which included mask noninvasive ventilation, high-flow nasal oxygen, and standard oxygen.<\/p>\n\n\n\n<p><strong>Main Outcomes and Measures<\/strong>&nbsp;&nbsp;The primary outcome was 28-day all-cause mortality. There were 12 prespecified secondary outcomes, including endotracheal intubation, barotrauma, skin pressure injury, and serious adverse events.<\/p>\n\n\n\n<p><strong>Results<\/strong>\u00a0\u00a0Among 322 patients who were randomized, 320 were included in the primary analysis, all of whom completed the trial. Median age was 58 years, and 187 were men (58.4%). Within 28 days, 43 of 159 patients (27.0%) died in the helmet noninvasive ventilation group compared with 42 of 161 (26.1%) in the usual respiratory support group (risk difference, 1.0% [95% CI, \u22128.7% to 10.6%]; relative risk, 1.04 [95% CI, 0.72-1.49];\u00a0<em>P<\/em>\u2009=\u2009.85). Within 28 days, 75 of 159 patients (47.2%) required endotracheal intubation in the helmet noninvasive ventilation group compared with 81 of 161 (50.3%) in the usual respiratory support group (risk difference, \u22123.1% [95% CI, \u221214.1% to 7.8%]; relative risk, 0.94 [95% CI, 0.75-1.17]). There were no significant differences between the 2 groups in any of the prespecified secondary end points. Barotrauma occurred in 30 of 159 patients (18.9%) in the helmet noninvasive ventilation group and 25 of 161 (15.5%) in the usual respiratory support group. Skin pressure injury occurred in 5 of 159 patients (3.1%) in the helmet noninvasive ventilation group and 10 of 161 (6.2%) in the usual respiratory support group. There were 2 serious adverse events in the helmet noninvasive ventilation group and 1 in the usual respiratory support group.<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" src=\"https:\/\/cdn.jamanetwork.com\/ama\/content_public\/journal\/jama\/938990\/joi220095va_1663338148.19206.png?Expires=1666741044&amp;Signature=YKMRLv6HIMAIGue7xOV7Qfwdw8DUd12JM8MYqcyfwgMZATB7mJLS7bqM8l371VI~qH6Pyey6~njKmd032sjI7~L6RVvP1bZjvANAYZ7LchCcPdVsTKq62ViIGyyijSzEytnk9lLGyH66B-wnOvpyPEUDhPWWh05sURVEfYB5f6yUsXT45rCIdL9YaJcRwIibFazuPPYkMdZ31b5mRSXB9bVUtFLuqWq7dJh3XPW5VhPSRmCNyReaQsyc-Cc6gBgsUbtrPrGXM6obsNYmk8zB5zP4-i8hnhHeyjeHvqph7RZfVUm25cJOU1yLLglRNppBKo4dCDeGQjdjDb78FhozgQ__&amp;Key-Pair-Id=APKAIE5G5CRDK6RD3PGA\" alt=\"\"\/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" src=\"https:\/\/cdn.jamanetwork.com\/ama\/content_public\/journal\/jama\/938990\/joi220095f1_1663338148.25897.png?Expires=1666741044&amp;Signature=1CQ1VA~vZ5QOfjH5TCf3kp09itpyYQ61DAHifPzYWYG7fcWT-imrRW1xsvVBD-D8Vs~Zpdcd1nHqIfR6uFZ5HEzqy4Y2-I532Zsuzx~T2nBbsrIhRcnK3KnFC26vOqS-QBjuXspSMzM5PSl8O~ieJgdy-w8c0p36Iu88JPnBE5Lx-YlDKFIQlSMYWy6JdyVhlaLi7ZgQvWVhGCZbfqmo8DbqzjBBm5bLVem1X68KhciaE8U10u0JIAiroVpyDuWwhx0EHnkQ48q37rWYoxLF25RQY50QEd1JmLlOwxUQkcIC~2MzbUL~jw0T~SlXkl0XrWgEjRgUEABMoQAqshDNTw__&amp;Key-Pair-Id=APKAIE5G5CRDK6RD3PGA\" alt=\"\"\/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" src=\"https:\/\/cdn.jamanetwork.com\/ama\/content_public\/journal\/jama\/938990\/joi220095f2_1663338148.31397.png?Expires=1666741044&amp;Signature=ZLZ~pAjHp2~npFL2qMttdpRXODpDMUm1SRup~pVXV3Lg8lBC78XxSmDuJkJ2Yf6EoOLoS6YAtzoRecVwp0-JvJbmQBN5i5W~AtvcxSVhnWRigiUA5zeM931XvkJrECrRPG~qJyQZXOoLXudn-4v4yo~9r01xlACkhpK5ki0y1lZQ0qf9r7M-4ewJ5GyiemGk9CIOfGY6wMuDjJcoQeTGmWkk5Wn0lOY0PHpVqVydMXNNUVBwo-lPYbHc6A-NV9oDUw5cmGxU07mNY0V17BsqGqyF1PbsJNguErpej6-PbRShhSV5pzGcPBhXtgg6JeGP5Aarf9vK0ItAnwjt11ZY8Q__&amp;Key-Pair-Id=APKAIE5G5CRDK6RD3PGA\" alt=\"\"\/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" src=\"https:\/\/cdn.jamanetwork.com\/ama\/content_public\/journal\/jama\/938990\/joi220095t1_1663338148.27436.png?Expires=1666741044&amp;Signature=qTtsvWT6BkNtmFKlw8Wsu76JEgDzp-~DY5vCyJhkYsgcW~wvIDfebrVGHakztQ-p3U8VCR6QbQAADEaalYCXbN-z~1Vo2HCd0lXd2cXKw3OxxlGYl3xsvsDZyH1J~Q1nxD8DP5W~lgVzL-~kSQQRG-TMnwIy0IISpDa8-W~vHaJ2W7-rKMeO9vO3poO8Tbokou3Bsj~Y2eM0jTOd-SIal1XGOgDf0zKjVPhbDGkkkKXNOUf75CXUgZ2-PCsprRIaxpVuLS~rty4O4xlZrkqMNdfYMB7yb4PKjjghNq26esWFqhKvqwOQI6QB5lQiRYYnC8egXXkkqiJqPTrGo2Qj8g__&amp;Key-Pair-Id=APKAIE5G5CRDK6RD3PGA\" alt=\"\"\/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" src=\"https:\/\/cdn.jamanetwork.com\/ama\/content_public\/journal\/jama\/938990\/joi220095t2_1663338148.28399.png?Expires=1666741044&amp;Signature=hYy8BrQQOWWjjf68yqteMPXWPrmpR3yz6UvASnz-N1AV4P4J3~4c5euUASypepuJJtz4UnqlwVW8MkQh4D5gJuHUidhCI4GLiTY2h7Kp41Yflx7rD5cobDgNP8zYZokmlvy0egr-qGrYAzQs2Wn9-0FFDLZkMm7nip1bRuT7XNNMyCEvaB0swli89NzHqfRQaL9XgJ9fQtyG7VmbDs2sGgBq1wv6nbufdXmUchOetH7WNfoNaxYiuW26Hh0ohDt6yGJkl3XmYl~jRbrQgV-DFpBkVtzHo5s0cfgoqNOWsfdQag--t6fNIinBI-716jW~IzG2JkstSenPokqsG8XGcg__&amp;Key-Pair-Id=APKAIE5G5CRDK6RD3PGA\" alt=\"\"\/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" src=\"https:\/\/cdn.jamanetwork.com\/ama\/content_public\/journal\/jama\/938990\/joi220095t3_1663338148.30397.png?Expires=1666741044&amp;Signature=BG8haDhG~moiXrzGrvqgCnXVus0UkyhyZCNfXQYnCtOqExc1DrwnrLzTIPMoCnYDYTI7jO0Gic-1Us-8vErxkF7Sn~pwGQf8EX-uj6OHjn9TZSY5a1aZDG-nZoRIyckx0lWM0XzGvh2VF2qbI30avkX9f6UxwyvXuMOnaIl8ku9nqcHP11CQ14YiZkUfZjlO5Z5cjySLspjoYpvSjdlp8-DQETiOYyvSNU-0bNbxa0XT7ftf2-8y1PFdESiBdsVfANC6oRxtT3nuj-4bdjG8POD0fZiD8uZI6Njw06aW-t0BY5oshHYji6xZKUauoiJnwUbmw4n0C0HtIgUt5MqdFw__&amp;Key-Pair-Id=APKAIE5G5CRDK6RD3PGA\" alt=\"\"\/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" src=\"https:\/\/cdn.jamanetwork.com\/ama\/content_public\/journal\/jama\/938990\/joi220095t4_1663338148.32902.png?Expires=1666741044&amp;Signature=yTSR6mGNpEtgPQiBh3Yoqjh0cuOEdmmBrIEjlpCbYRX39k0Wupmd0PP8OTbhMlysPzIBR-xXOt26NYkBJsYs6~5qFgZ2CbenTC7tlU5G80J4ItyCwtZt9Cfq~Obg7Io7LkaRc8Dh~MAigLB3QEngOVR-qD7CfRajmSAIxkhrDmlRgfm6MYOmmqPsxiQR6uYlnflxG4aaJOZj9IRMtjFvfFmXFNCo0C-8pa2aVuSPXwF5eeyxs~DXg-g0~MP58C-nHJXOl~IJVvVKkUoDLDwg8A6Up~Z4mtMXRULDgFjpLWlFmEG2LERZ-YgrvqpacosM-66hG-nUPKw~zbcE0M~acg__&amp;Key-Pair-Id=APKAIE5G5CRDK6RD3PGA\" alt=\"\"\/><\/figure>\n\n\n\n<p><strong>Conclusions and Relevance<\/strong>&nbsp;&nbsp;Results of this study suggest that helmet noninvasive ventilation did not significantly reduce 28-day mortality compared with usual respiratory support among patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia. However, interpretation of the findings is limited by imprecision in the effect estimate, which does not exclude potentially clinically important benefit or harm.<\/p>\n\n\n\n<p><strong>Trial Registration<\/strong>&nbsp;&nbsp;ClinicalTrials.gov Identifier:&nbsp;<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04477668\">NCT04477668<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Original Investigation&nbsp; September&nbsp;20,&nbsp;20 [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[32,23],"tags":[],"_links":{"self":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/22651"}],"collection":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=22651"}],"version-history":[{"count":1,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/22651\/revisions"}],"predecessor-version":[{"id":22652,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/22651\/revisions\/22652"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=22651"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=22651"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=22651"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}