{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T01:03:28Z","timestamp":1790643808527,"version":"4.1.0"},"reference-count":20,"publisher":"BMJ","issue":"9","content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2018,7,26]]},"published-print":{"date-parts":[[2018,9]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>This study protocol describes a trial designed to investigate whether high-flow heated and humidified nasal oxygen (HFHO) therapy in patients with hypercapnic acute respiratory failure (ARF) reduces the need of non-invasive ventilation (NIV).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This is an open-label, superiority, international, parallel-group, multicentre randomised controlled two-arm trial, with an internal feasibility pilot phase. 242 patients with hypercapnic ARF requiring NIV admitted to an intensive care unit, an intermediate care or a respiratory care unit will be randomised in a 1:1 ratio to receive HFHO or standard oxygen in between NIV sessions. Randomisation will be centralised and stratified by centre and pH at admission (pH \u22647.25\u2009or &gt;7.25). The primary outcome will be the number of ventilator-free days (VFDs) and alive at day 28 postrandomisation. The secondary outcomes will encompass parameters related to the VFDs, comfort and tolerance variables, hospital length of stay and mortality. VFDs at 28 days postrandomisation will be compared between the two groups by Wilcoxon-Mann-Whitney two-sample rank-sum test in the intention-to-treat population. A sensitivity analysis will be conducted in the population of patients for whom the criteria of switching from NIV to spontaneous breathing, or conversely, are not strictly verified.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>\n                      The protocol has been approved by the\n                      <jats:italic>Comit\u00e9 de Protection des Personnes<\/jats:italic>\n                      (CPP)\n                      <jats:italic>Sud-Ouest &amp; Outre-Mer IV<\/jats:italic>\n                      (ref CPP17-049a\/2017-A01830-53) and will be carried out in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. A trial steering committee will oversee the progress of the study. Findings will be disseminated through national and international scientific conferences, and publication in peer-reviewed journals.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"NCT03406572\" ext-link-type=\"clintrialgov\">NCT03406572<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2018-022983","type":"journal-article","created":{"date-parts":[[2018,9,20]],"date-time":"2018-09-20T10:53:36Z","timestamp":1537440816000},"page":"e022983","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":29,"title":["Comparison of high flow nasal cannula oxygen and conventional oxygen therapy on ventilatory support duration during acute-on-chronic respiratory failure: study protocol of a multicentre, randomised, controlled trial. The \u2018HIGH-FLOW ACRF\u2019 study"],"prefix":"10.1136","volume":"8","clinical-trial-number":[{"clinical-trial-number":"nct03406572","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Jean-Damien","family":"Ricard","sequence":"first","affiliation":[{"name":"Service de R\u00e9animation M\u00e9dico-Chirurgicale, AP-HP, H\u00f4pital Louis Mourier, Colombes, France"},{"name":"INSERM, IAME, UMR 1137, Paris, France"},{"name":"Universit\u00e9 Paris Diderot, IAME, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fadia","family":"Dib","sequence":"additional","affiliation":[{"name":"D\u00e9partement Epid\u00e9miologie, Biostatistiques et Rehcherche Clinique, Hopital Bichat - Claude-Bernard, Paris, France"},{"name":"INSERM, CIC-EC 1425, Paris, France"},{"name":"INSERM, ECEVE, UMR 1123, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marina","family":"Esposito-Farese","sequence":"additional","affiliation":[{"name":"D\u00e9partement Epid\u00e9miologie, Biostatistiques et Rehcherche Clinique, Hopital Bichat - Claude-Bernard, Paris, France"},{"name":"INSERM, CIC-EC 1425, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan","family":"Messika","sequence":"additional","affiliation":[{"name":"Service de R\u00e9animation M\u00e9dico-Chirurgicale, AP-HP, H\u00f4pital Louis Mourier, Colombes, France"},{"name":"INSERM, IAME, UMR 1137, Paris, France"},{"name":"Universit\u00e9 Paris Diderot, IAME, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christophe","family":"Girault","sequence":"additional","affiliation":[{"name":"Department of Medical Intensive Care, Charles Nicolle University Hospital, Rouen University, Rouen, France"},{"name":"UNIROUEN, EA3830-GRHV, Normandie University, Institute for Research and Innovation in Biomedicine(IRIB), Rouen, France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2018,9,19]]},"reference":[{"key":"2025120519494014000_8.9.e022983.1","doi-asserted-by":"publisher","DOI":"10.1378\/chest.13-0809"},{"key":"2025120519494014000_8.9.e022983.2","doi-asserted-by":"publisher","DOI":"10.1136\/thoraxjnl-2015-208209"},{"key":"2025120519494014000_8.9.e022983.3","doi-asserted-by":"crossref","first-page":"582","DOI":"10.1007\/s00134-014-3222-y","article-title":"Noninvasive mechanical ventilation in acute respiratory failure: trends in use and outcomes","volume":"40","author":"Schnell","year":"2014","journal-title":"Intensive Care Med"},{"key":"2025120519494014000_8.9.e022983.4","doi-asserted-by":"crossref","first-page":"82","DOI":"10.1007\/s00134-015-4087-4","article-title":"Changing use of noninvasive ventilation in critically ill patients: trends over 15 years in francophone countries","volume":"42","author":"Demoule","year":"2016","journal-title":"Intensive Care Med"},{"key":"2025120519494014000_8.9.e022983.5","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1503326"},{"key":"2025120519494014000_8.9.e022983.6","doi-asserted-by":"publisher","DOI":"10.1378\/chest.14-2871"},{"key":"2025120519494014000_8.9.e022983.7","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-158-3-201302050-00583"},{"key":"2025120519494014000_8.9.e022983.8","doi-asserted-by":"publisher","DOI":"10.1097\/00003246-200208000-00016"},{"key":"2025120519494014000_8.9.e022983.9","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2288-10-1"},{"key":"2025120519494014000_8.9.e022983.10","doi-asserted-by":"crossref","first-page":"A422","DOI":"10.1186\/2197-425X-3-S1-A422","article-title":"An international phase iii randomised trial on the efficacy of helium\/oxygen during spontaneous breathing and intermittent non-invasive ventilation for severe exacerbations of chronic obstructive pulmonary disease (the e.c.h.o.icutrial)","volume":"3","author":"Jolliet","year":"2015","journal-title":"Intensive Care Med Exp"},{"key":"2025120519494014000_8.9.e022983.11","doi-asserted-by":"publisher","DOI":"10.1097\/CCM.0b013e3181b78abe"},{"key":"2025120519494014000_8.9.e022983.12","doi-asserted-by":"crossref","first-page":"1914.e1","DOI":"10.1016\/j.ajem.2016.02.020","article-title":"High-flow nasal cannula oxygen supply as treatment in hypercapnic respiratory failure","volume":"34","author":"Lepere","year":"2016","journal-title":"Am J Emerg Med"},{"key":"2025120519494014000_8.9.e022983.13","doi-asserted-by":"publisher","DOI":"10.1159\/000342027"},{"key":"2025120519494014000_8.9.e022983.14","doi-asserted-by":"crossref","first-page":"27","DOI":"10.1186\/s40248-015-0019-y","article-title":"Nasal High-flow versus non-invasive ventilation in stable hypercapnic COPD: a preliminary report","volume":"10","author":"Br\u00e4unlich","year":"2015","journal-title":"Multidiscip Respir Med"},{"key":"2025120519494014000_8.9.e022983.15","doi-asserted-by":"publisher","DOI":"10.2147\/COPD.S104616"},{"key":"2025120519494014000_8.9.e022983.16","doi-asserted-by":"publisher","DOI":"10.1136\/thoraxjnl-2016-209673"},{"key":"2025120519494014000_8.9.e022983.17","doi-asserted-by":"publisher","DOI":"10.1136\/thoraxjnl-2015-207962"},{"key":"2025120519494014000_8.9.e022983.18","doi-asserted-by":"publisher","DOI":"10.4187\/respcare.03075"},{"key":"2025120519494014000_8.9.e022983.19","doi-asserted-by":"crossref","unstructured":"Spoletini G , Mega C , Khoja A , et al . 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