{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,22]],"date-time":"2025-10-22T18:23:22Z","timestamp":1761157402775},"reference-count":25,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2022,7,19]],"date-time":"2022-07-19T00:00:00Z","timestamp":1658188800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,7,19]],"date-time":"2022-07-19T00:00:00Z","timestamp":1658188800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Scientific Research Project of Jiangsu Commission of Health","award":["M2020014"],"award-info":[{"award-number":["M2020014"]}]},{"name":"hospital-level support project of Northern Jiangsu People\u2019s Hospital","award":["yzucms201805"],"award-info":[{"award-number":["yzucms201805"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"published-print":{"date-parts":[[2022,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>High-flow nasal cannula oxygen therapy (HFNC) is recommended by some scholars as an optimized respiratory support method for blunt chest trauma (BCT) patients. The basis of this recommendation is limited, however, and the efficacy of HFNC or noninvasive ventilation (NIV) in BCT patients has not yet been rigorously explored. This study aims to determine if HFNC is non-inferior to NIV in reducing treatment failure in moderate to severe BCT patients with acute respiratory failure.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This will be a prospective, open-label, multicenter, non-inferiority, randomized controlled trial. Moderate to severe BCT patients with acute respiratory failure (100mmHg &lt; PaO<jats:sub>2<\/jats:sub>\/FiO<jats:sub>2<\/jats:sub>\u2266 200mmHg) who do not need immediate intubation will be randomized to HFNC or NIV within 48 h after trauma. The primary outcome is treatment failure, defined as invasive ventilation or a switch in respiratory support modality (from HFNC to NIV or vice-versa). Secondary outcomes include arterial blood gas analysis and vital signs at 2 and 12 h after initiating HFNC or NIV treatment, as well as patients\u2019 comfort scores, dyspnea scores, daily number of nursing airway care interventions, incidence of pneumonia or pneumothorax, facial skin breakdown, duration of NIV or HFNC, 28-day mortality, and total ICU and hospital lengths of stay. Based on an<jats:italic>\u03b1<\/jats:italic>error of 5% and a<jats:italic>\u03b2<\/jats:italic>error of 80%, with a non-inferiority limit of 9%, a sample size of 562 will be required to accomplish the trial goal, considering potential patient dropouts and nonparametric analysis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>We hypothesize that HFNC will be non-inferior to NIV in reducing treatment failure in moderate to severe BCT with acute respiratory failure. The results should be useful for judging whether HFNC could be an effective alternative to NIV to treat moderate to severe BCT patients, especially for those who do not tolerate or have contraindications for NIV.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration<\/jats:title><jats:p>Chinese Clinical Trial Registry<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.chictr.org.cn\/showproj.aspx?proj=29361\">ChiCTR1800017313<\/jats:ext-link>. Registered on July 24, 2018.<\/jats:p><\/jats:sec>","DOI":"10.1186\/s13063-022-06507-2","type":"journal-article","created":{"date-parts":[[2022,7,19]],"date-time":"2022-07-19T11:06:59Z","timestamp":1658228819000},"update-policy":"http:\/\/dx.doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["High-flow nasal cannula oxygen therapy versus noninvasive ventilation for patients with blunt chest trauma: protocol for a randomized controlled trial"],"prefix":"10.1186","volume":"23","author":[{"given":"Qingcheng","family":"Zhu","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bingxia","family":"Wang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yujie","family":"Li","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bingyu","family":"Ling","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jun","family":"Xu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kui","family":"Jin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ming","family":"Sun","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jianjun","family":"Zhu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joseph","family":"Walline","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yunyun","family":"Wang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peng","family":"Cao","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiaojuan","family":"Guo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dingyu","family":"Tan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2022,7,19]]},"reference":[{"key":"6507_CR1","doi-asserted-by":"publisher","first-page":"S172-s7","DOI":"10.21037\/jtd.2017.03.52","volume":"9","author":"C Ludwig","year":"2017","unstructured":"Ludwig C, Koryllos A. Management of chest trauma. J Thorac Dis. 2017;9:S172-s7. https:\/\/doi.org\/10.21037\/jtd.2017.03.52.","journal-title":"J Thorac Dis"},{"key":"6507_CR2","doi-asserted-by":"publisher","first-page":"R142","DOI":"10.1186\/cc12821","volume":"17","author":"A Duggal","year":"2013","unstructured":"Duggal A, Perez P, Golan E, Tremblay L, Sinuff T. Safety and efficacy of noninvasive ventilation in patients with blunt chest trauma: a systematic review. Crit Care. 2013;17:R142. https:\/\/doi.org\/10.1186\/cc12821.","journal-title":"Crit Care"},{"key":"6507_CR3","first-page":"35","volume":"7","author":"M Nasr-Esfahani","year":"2019","unstructured":"Nasr-Esfahani M, Boroumand AB, Kolahdouzan M. Early intubation vs. supportive care in management of severe blunt chest trauma; a randomized trial study. Arch Acad Emerg Med. 2019;7:35.","journal-title":"Arch Acad Emerg Med"},{"key":"6507_CR4","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1097\/MCC.0b013e32835c34a5","volume":"19","author":"G Bello","year":"2013","unstructured":"Bello G, De Pascale G, Antonelli M. Noninvasive ventilation: practical advice. Curr Opin Crit Care. 2013;19:1\u20138. https:\/\/doi.org\/10.1097\/MCC.0b013e32835c34a5.","journal-title":"Curr Opin Crit Care"},{"key":"6507_CR5","doi-asserted-by":"publisher","first-page":"325","DOI":"10.1136\/emj.2004.019786","volume":"22","author":"M Gunduz","year":"2005","unstructured":"Gunduz M, Unlugenc H, Ozalevli M, Inanoglu K, Akman H. A comparative study of continuous positive airway pressure (CPAP) and intermittent positive pressure ventilation (IPPV) in patients with flail chest. Emerg Med J. 2005;22:325\u20139. https:\/\/doi.org\/10.1136\/emj.2004.019786.","journal-title":"Emerg Med J"},{"key":"6507_CR6","doi-asserted-by":"publisher","first-page":"943","DOI":"10.1378\/chest.97.4.943","volume":"97","author":"CT Bolliger","year":"1990","unstructured":"Bolliger CT, Van Eeden SF. Treatment of multiple rib fractures. Randomized controlled trial comparing ventilatory with nonventilatory management. Chest. 1990;97:943\u20138. https:\/\/doi.org\/10.1378\/chest.97.4.943.","journal-title":"Chest."},{"key":"6507_CR7","doi-asserted-by":"publisher","first-page":"74","DOI":"10.1378\/chest.09-1114","volume":"137","author":"G Hernandez","year":"2010","unstructured":"Hernandez G, Fernandez R, Lopez-Reina P, Cuena R, Pedrosa A, Ortiz R, et al. Noninvasive ventilation reduces intubation in chest trauma-related hypoxemia: a randomized clinical trial. Chest. 2010;137:74\u201380. https:\/\/doi.org\/10.1378\/chest.09-1114.","journal-title":"Chest."},{"key":"6507_CR8","doi-asserted-by":"publisher","first-page":"1171","DOI":"10.1007\/s00134-013-2901-4","volume":"39","author":"D Chiumello","year":"2013","unstructured":"Chiumello D, Coppola S, Froio S, Gregoretti C, Consonni D. Noninvasive ventilation in chest trauma: systematic review and meta-analysis. Intensive Care Med. 2013;39:1171\u201380. https:\/\/doi.org\/10.1007\/s00134-013-2901-4.","journal-title":"Intensive Care Med"},{"key":"6507_CR9","doi-asserted-by":"publisher","first-page":"2352","DOI":"10.1001\/jama.284.18.2352","volume":"284","author":"C Delclaux","year":"2000","unstructured":"Delclaux C, L'Her E, Alberti C, Mancebo J, Abroug F, Conti G, et al. Treatment of acute hypoxemic nonhypercapnic respiratory insufficiency with continuous positive airway pressure delivered by a face mask: a randomized controlled trial. Jama. 2000;284:2352\u201360. https:\/\/doi.org\/10.1001\/jama.284.18.2352.","journal-title":"Jama."},{"key":"6507_CR10","doi-asserted-by":"publisher","first-page":"461","DOI":"10.1186\/s12913-019-4177-z","volume":"19","author":"S Kourouche","year":"2019","unstructured":"Kourouche S, Buckley T, Van C, Munroe B, Curtis K. Designing strategies to implement a blunt chest injury care bundle using the behaviour change wheel: a multi-site mixed methods study. BMC Health Serv Res. 2019;19:461. https:\/\/doi.org\/10.1186\/s12913-019-4177-z.","journal-title":"BMC Health Serv Res"},{"key":"6507_CR11","doi-asserted-by":"publisher","first-page":"127","DOI":"10.1016\/j.aenj.2016.06.002","volume":"19","author":"K Curtis","year":"2016","unstructured":"Curtis K, Asha SE, Unsworth A, Lam M, Goldsmith H, Langcake M, et al. ChIP: an early activation protocol for isolated blunt chest injury improves outcomes, a retrospective cohort study. Australas Emerg Nurs J. 2016;19:127\u201332. https:\/\/doi.org\/10.1016\/j.aenj.2016.06.002.","journal-title":"Australas Emerg Nurs J"},{"key":"6507_CR12","first-page":"110","volume":"52","author":"ME Halub","year":"2016","unstructured":"Halub ME, Spilman SK, Gaunt KA, Lamb KD, Jackson JA, Oetting TW, et al. High-flow nasal cannula therapy for patients with blunt thoracic injury: a retrospective study. Can J Respir Ther. 2016;52:110\u20133.","journal-title":"Can J Respir Ther"},{"key":"6507_CR13","doi-asserted-by":"publisher","unstructured":"Lu X, Wu C, Gao Y, Zhang M. Bedside ultrasound assessment of lung reaeration in patients with blunt thoracic injury receiving high-flow nasal cannula oxygen therapy: a retrospective study. J Intensive Care Med. 2018:885066618815649. https:\/\/doi.org\/10.1177\/0885066618815649.","DOI":"10.1177\/0885066618815649"},{"issue":"3","key":"6507_CR14","doi-asserted-by":"publisher","first-page":"187","DOI":"10.1097\/00005373-197403000-00001","volume":"14","author":"SP Baker","year":"1974","unstructured":"Baker SP, O\u2019Neill B, Haddon W Jr, Long WB. The injury severity score: a method for describing patients with multiple injuries and evaluating emergency care. J Trauma. 1974;14(3):187\u201396.","journal-title":"J Trauma"},{"key":"6507_CR15","doi-asserted-by":"publisher","first-page":"125","DOI":"10.1016\/j.cjtee.2020.04.003","volume":"23","author":"BN Dogrul","year":"2020","unstructured":"Dogrul BN, Kiliccalan I, Asci ES, Peker SC. Blunt trauma related chest wall and pulmonary injuries: an overview. Chin J Traumatol. 2020;23:125\u201338. https:\/\/doi.org\/10.1016\/j.cjtee.2020.04.003.","journal-title":"Chin J Traumatol"},{"key":"6507_CR16","doi-asserted-by":"crossref","first-page":"92","DOI":"10.2340\/1650197719702239298","volume":"2","author":"G Borg","year":"1970","unstructured":"Borg G. Perceived exertion as an indicator of somatic stress. Scand J Rehabil Med. 1970;2:92\u20138.","journal-title":"Scand J Rehabil Med"},{"key":"6507_CR17","doi-asserted-by":"publisher","first-page":"1077","DOI":"10.2147\/copd.S104616","volume":"11","author":"J Braunlich","year":"2016","unstructured":"Braunlich J, Kohler M, Wirtz H. Nasal highflow improves ventilation in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2016;11:1077\u201385. https:\/\/doi.org\/10.2147\/copd.S104616.","journal-title":"Int J Chron Obstruct Pulmon Dis"},{"key":"6507_CR18","doi-asserted-by":"publisher","first-page":"2331","DOI":"10.1001\/jama.2015.5213","volume":"313","author":"F St\u00e9phan","year":"2015","unstructured":"St\u00e9phan F, Barrucand B, Petit P, R\u00e9zaiguia-Delclaux S, M\u00e9dard A, Delannoy B, et al. High-flow nasal oxygen vs noninvasive positive airway pressure in hypoxemic patients after cardiothoracic surgery: a randomized clinical trial. Jama. 2015;313:2331\u20139. https:\/\/doi.org\/10.1001\/jama.2015.5213.","journal-title":"Jama."},{"key":"6507_CR19","doi-asserted-by":"publisher","first-page":"100","DOI":"10.1016\/j.rmed.2016.11.004","volume":"121","author":"CC Lee","year":"2016","unstructured":"Lee CC, Mankodi D, Shaharyar S, Ravindranathan S, Danckers M, Herscovici P, et al. High flow nasal cannula versus conventional oxygen therapy and non-invasive ventilation in adults with acute hypoxemic respiratory failure: a systematic review. Respir Med. 2016;121:100\u20138. https:\/\/doi.org\/10.1016\/j.rmed.2016.11.004.","journal-title":"Respir Med"},{"key":"6507_CR20","doi-asserted-by":"publisher","first-page":"E195","DOI":"10.1503\/cmaj.100071","volume":"183","author":"SP Keenan","year":"2011","unstructured":"Keenan SP, Sinuff T, Burns KE, Muscedere J, Kutsogiannis J, Mehta S, et al. Clinical practice guidelines for the use of noninvasive positive-pressure ventilation and noninvasive continuous positive airway pressure in the acute care setting. Cmaj. 2011;183:E195\u2013214. https:\/\/doi.org\/10.1503\/cmaj.100071.","journal-title":"Cmaj."},{"key":"6507_CR21","doi-asserted-by":"publisher","unstructured":"Non-invasive ventilation in acute respiratory failure. Thorax. 2002;57:192\u2013211. https:\/\/doi.org\/10.1136\/thorax.57.3.192.","DOI":"10.1136\/thorax.57.3.192"},{"key":"6507_CR22","doi-asserted-by":"publisher","first-page":"73","DOI":"10.1016\/j.annemergmed.2017.12.006","volume":"72","author":"P Doshi","year":"2018","unstructured":"Doshi P, Whittle JS, Bublewicz M, Kearney J, Ashe T, Graham R, et al. High-velocity nasal insufflation in the treatment of respiratory failure: a randomized clinical trial. Ann Emerg Med. 2018;72:73\u201383.e5. https:\/\/doi.org\/10.1016\/j.annemergmed.2017.12.006.","journal-title":"Ann Emerg Med"},{"key":"6507_CR23","doi-asserted-by":"publisher","first-page":"529","DOI":"10.4187\/respcare.04577","volume":"61","author":"M Nishimura","year":"2016","unstructured":"Nishimura M. High-flow nasal cannula oxygen therapy in adults: physiological benefits, indication, clinical benefits, and adverse effects. Respir Care. 2016;61:529\u201341. https:\/\/doi.org\/10.4187\/respcare.04577.","journal-title":"Respir Care"},{"key":"6507_CR24","doi-asserted-by":"publisher","first-page":"2185","DOI":"10.1056\/NEJMoa1503326","volume":"372","author":"JP Frat","year":"2015","unstructured":"Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, et al. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015;372:2185\u201396. https:\/\/doi.org\/10.1056\/NEJMoa1503326.","journal-title":"N Engl J Med"},{"key":"6507_CR25","doi-asserted-by":"publisher","first-page":"e506","DOI":"10.1097\/ccm.0000000000003740","volume":"47","author":"F Longhini","year":"2019","unstructured":"Longhini F, Pisani L, Lungu R, Comellini V, Bruni A, Garofalo E, et al. High-flow oxygen therapy after noninvasive ventilation interruption in patients recovering from hypercapnic acute respiratory failure: a physiological crossover trial. Crit Care Med. 2019;47:e506\u2013e11. https:\/\/doi.org\/10.1097\/ccm.0000000000003740.","journal-title":"Crit Care Med"}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-022-06507-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13063-022-06507-2\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-022-06507-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,11,24]],"date-time":"2023-11-24T19:00:30Z","timestamp":1700852430000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-022-06507-2"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,7,19]]},"references-count":25,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2022,12]]}},"alternative-id":["6507"],"URL":"https:\/\/doi.org\/10.1186\/s13063-022-06507-2","relation":{},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,7,19]]},"assertion":[{"value":"10 April 2021","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"5 July 2022","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"19 July 2022","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This study has been approved by the Ethics Committee of Northern Jiangsu People\u2019s Hospital, Yangzhou, China (2018KY-076, approved on February 26, 2018). The local ethics committees of participating hospitals have also approved the study protocol. Patients will be enrolled after obtaining written informed consent from themselves or next of kin, and they will have the right to withdraw from the study or withdraw their informed consent at any time and for any reason.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not required.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"570"}}