{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,9]],"date-time":"2026-07-09T15:53:42Z","timestamp":1783612422127,"version":"3.55.0"},"reference-count":32,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2026,3,24]],"date-time":"2026-03-24T00:00:00Z","timestamp":1774310400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,5,12]],"date-time":"2026-05-12T00:00:00Z","timestamp":1778544000000},"content-version":"vor","delay-in-days":49,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100009708","name":"Novo Nordisk Fonden","doi-asserted-by":"publisher","award":["NNF21OC0072604"],"award-info":[{"award-number":["NNF21OC0072604"]}],"id":[{"id":"10.13039\/501100009708","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Herman Salling Foundation","award":["2022-0081"],"award-info":[{"award-number":["2022-0081"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Sci Rep"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    After tracheostomy decannulation, stoma openings compromise airway integrity, reduce subglottic pressure, and impair cough efficiency. Conventional external dressings are often not airtight and require extensive maintenance, increasing the risk of delayed healing and pulmonary complications. We evaluated the feasibility, physiological impact, and patient-reported outcomes of an intratracheal sealing disc designed to maintain airway integrity during early post-decannulation healing. In this feasibility study, 21 tracheostomized patients were enrolled from the Department of Intensive Care at Aarhus University Hospital and G\u00f8dstrup Regional Hospital (pilot phase,\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u200911; main study,\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u200910). Immediately after decannulation, a sealing disc was inserted intratracheally and secured externally for up to 7 days. Spirometry, voice quality, and tracheostomy healing were assessed daily. Patient satisfaction was measured using a questionnaire with a 5-point Likert scale. The sealing disc provided an airtight closure during speaking and coughing. Placement and removal were quick and uneventful. Patient satisfaction overall reached a median (interquartile range) score of 5\/5 (1). Forced vital capacity, forced expiratory volume in the first second, and voice quality improved significantly immediately after sealing and remained stable during wear and after removal. In this First-in-Man clinical feasibility study, intratracheal sealing immediately after decannulation proved feasible, well-tolerated, and may improve pulmonary function, phonation, and wound healing. Larger controlled studies are warranted.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>Trial Registration<\/jats:bold>\n                    : This trial was retrospectively registered at ClinicalTrials.gov with the identifier NCT07149116 \u2013 date of registration: 08\/08\/2025.\n                  <\/jats:p>","DOI":"10.1038\/s41598-026-41209-8","type":"journal-article","created":{"date-parts":[[2026,3,23]],"date-time":"2026-03-23T23:52:06Z","timestamp":1774309926000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Clinical feasibility of intratracheal tracheostomy sealing using a novel sealing disc prototype"],"prefix":"10.1038","volume":"16","author":[{"given":"Rasmus Ellerup","family":"Kraghede","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Louise Winding","family":"Nielsen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karen Juelsgaard","family":"Christiansen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stig","family":"Dyrskog","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nilanjan","family":"Dey","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander Emil","family":"Kaspersen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J. Michael","family":"Hasenkam","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,3,24]]},"reference":[{"key":"41209_CR1","doi-asserted-by":"publisher","unstructured":"Rana, S. et al. Tracheostomy in critically Ill patients. Mayo Clin.  Proc. 80 1632\u20131638. https:\/\/doi.org\/10.4065\/80.12.1632 (2005).","DOI":"10.4065\/80.12.1632"},{"key":"41209_CR2","doi-asserted-by":"publisher","first-page":"1056","DOI":"10.4187\/respcare.10551056","volume":"55","author":"CG Durbin","year":"2010","unstructured":"Durbin, C. G. Tracheostomy: why, when, and how? Respir Care. 55, 1056\u20131068 (2010).","journal-title":"Respir Care"},{"key":"41209_CR3","doi-asserted-by":"publisher","unstructured":"Christiansen, K. J. et al. Tracheostomy healing time after decannulation. Multidis. Res. Med. 17 https:\/\/doi.org\/10.4081\/mrm.2022.822 (2022).","DOI":"10.4081\/mrm.2022.822"},{"key":"41209_CR4","unstructured":"John Hopkins Medicine Tracheostomy. In: Johns Hopkins Medicine. https:\/\/www.hopkinsmedicine.org\/health\/treatment-tests-and-therapies\/tracheostomy (Accessed 8 September 2025)."},{"key":"41209_CR5","doi-asserted-by":"publisher","first-page":"440","DOI":"10.1089\/respcare.12149","volume":"70","author":"LL Morris","year":"2025","unstructured":"Morris, L. L. et al. Tracheal Stoma Closure and Healing Time in a Post-Acute Setting. Respir Care. 70, 440\u2013445. https:\/\/doi.org\/10.1089\/respcare.12149 (2025).","journal-title":"Respir Care"},{"key":"41209_CR6","doi-asserted-by":"publisher","first-page":"834716","DOI":"10.3389\/fphys.2022.834716","volume":"13","author":"RL Goetz","year":"2022","unstructured":"Goetz, R. L., Vijaykumar, K. & Solomon, G. M. Mucus Clearance Strategies in Mechanically Ventilated Patients. Front. Physiol. 13, 834716. https:\/\/doi.org\/10.3389\/fphys.2022.834716 (2022).","journal-title":"Front. Physiol."},{"key":"41209_CR7","doi-asserted-by":"publisher","first-page":"1413","DOI":"10.1016\/j.chest.2021.04.039","volume":"160","author":"L McGarvey","year":"2021","unstructured":"McGarvey, L. et al. Global Physiology and Pathophysiology of Cough: Part 2. Demographic and Clinical Considerations: CHEST Expert Panel Report. Chest 160, 1413\u20131423. https:\/\/doi.org\/10.1016\/j.chest.2021.04.039 (2021).","journal-title":"Chest"},{"key":"41209_CR8","doi-asserted-by":"publisher","first-page":"38","DOI":"10.1186\/s40560-017-0234-z","volume":"5","author":"RK Singh","year":"2017","unstructured":"Singh, R. K., Saran, S. & Baronia, A. K. The practice of tracheostomy decannulation-a systematic review. J. Intensive Care. 5, 38. https:\/\/doi.org\/10.1186\/s40560-017-0234-z (2017).","journal-title":"J. Intensive Care"},{"key":"41209_CR9","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1093\/ptj\/pzab254","volume":"102","author":"KA Saliba","year":"2022","unstructured":"Saliba, K. A., Blackstock, F., McCarren, B. & Tang, C. Y. Effect of Positive Expiratory Pressure Therapy on Lung Volumes and Health Outcomes in Adults With Chest Trauma: A Systematic Review and Meta-Analysis. Phys. Ther. 102, 1\u201311. https:\/\/doi.org\/10.1093\/ptj\/pzab254 (2022).","journal-title":"Phys. Ther."},{"key":"41209_CR10","doi-asserted-by":"publisher","first-page":"e38786","DOI":"10.7759\/cureus.38786","volume":"15","author":"J Lusquinhos","year":"2023","unstructured":"Lusquinhos, J., Tavares, M. & Abelha, F. Postoperative Pulmonary Complications and Perioperative Strategies. Syst. Rev. Cureus. 15, e38786. https:\/\/doi.org\/10.7759\/cureus.38786 (2023).","journal-title":"Syst. Rev. Cureus"},{"key":"41209_CR11","doi-asserted-by":"publisher","unstructured":"McCool, F. D. Global physiology and pathophysiology of cough: ACCP evidence-based clinical practice guidelines. Chest 129 48S-53S. https:\/\/doi.org\/10.1378\/chest.129.1_suppl.48S (2006).","DOI":"10.1378\/chest.129.1_suppl.48S"},{"key":"41209_CR12","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1177\/20406223221109655","volume":"13","author":"A Ghiani","year":"2022","unstructured":"Ghiani, A. et al. Incidence, causes, and predictors of unsuccessful decannulation following prolonged weaning. Therapeutic Adv. Chronic Disease. 13, 1\u201313. https:\/\/doi.org\/10.1177\/20406223221109655 (2022).","journal-title":"Therapeutic Adv. Chronic Disease"},{"key":"41209_CR13","doi-asserted-by":"publisher","first-page":"10","DOI":"10.1016\/j.iccn.2018.02.004","volume":"46","author":"AL Freeman-Sanderson","year":"2018","unstructured":"Freeman-Sanderson, A. L., Togher, L., Elkins, M. & Kenny, B. Quality of life improves for tracheostomy patients with return of voice: A mixed methods evaluation of the patient experience across the care continuum. Intensive Crit. Care Nurs. 46, 10\u201316. https:\/\/doi.org\/10.1016\/j.iccn.2018.02.004 (2018).","journal-title":"Intensive Crit. Care Nurs."},{"key":"41209_CR14","doi-asserted-by":"publisher","first-page":"154145","DOI":"10.1016\/j.jcrc.2022.154145","volume":"72","author":"H Newman","year":"2022","unstructured":"Newman, H. et al. What matters most to adults with a tracheostomy in ICU and the implications for clinical practice: a qualitative systematic review and metasynthesis. J. Crit. Care. 72, 154145. https:\/\/doi.org\/10.1016\/j.jcrc.2022.154145 (2022).","journal-title":"J. Crit. Care"},{"key":"41209_CR15","doi-asserted-by":"publisher","first-page":"970","DOI":"10.4187\/respcare.05301","volume":"62","author":"KJ Christiansen","year":"2017","unstructured":"Christiansen, K. J. et al. Intratracheal Seal Disc: A Novel Tracheostoma Closure Device. Respir Care. 62, 970\u2013977. https:\/\/doi.org\/10.4187\/respcare.05301 (2017).","journal-title":"Respir Care"},{"key":"41209_CR16","doi-asserted-by":"publisher","first-page":"852","DOI":"10.3390\/biomedicines12040852","volume":"12","author":"RE Kraghede","year":"2024","unstructured":"Kraghede, R. E. et al. Novel Method for Sealing Tracheostomies Immediately after Decannulation\u2014An Acute Clinical Feasibility Study. Biomedicines 12, 852. https:\/\/doi.org\/10.3390\/biomedicines12040852 (2024).","journal-title":"Biomedicines"},{"key":"41209_CR17","doi-asserted-by":"publisher","first-page":"8","DOI":"10.1016\/j.aucc.2008.10.002","volume":"22","author":"K Choate","year":"2009","unstructured":"Choate, K., Barbetti, J. & Currey, J. Tracheostomy decannulation failure rate following critical illness: a prospective descriptive study. Aust Crit. Care. 22, 8\u201315. https:\/\/doi.org\/10.1016\/j.aucc.2008.10.002 (2009).","journal-title":"Aust Crit. Care"},{"key":"41209_CR18","doi-asserted-by":"publisher","unstructured":"Kraghede, R. E. et al. Feasibility of intratracheal tracheostomy sealing: anatomical adaptation and biocompatibility of a second-generation prototype in cadaveric and porcine models. Springer Nat. Sci. Rep. https:\/\/doi.org\/10.1038\/s41598-025-21640-z","DOI":"10.1038\/s41598-025-21640-z"},{"key":"41209_CR19","doi-asserted-by":"publisher","first-page":"239","DOI":"10.1186\/s13643-017-0634-0","volume":"6","author":"J Kutsukutsa","year":"2017","unstructured":"Kutsukutsa, J., Mashamba-Thompson, T. P. & Saman, Y. Tracheostomy decannulation methods and procedures in adults: a systematic scoping review protocol. Syst. Rev. 6, 239. https:\/\/doi.org\/10.1186\/s13643-017-0634-0 (2017).","journal-title":"Syst. Rev."},{"key":"41209_CR20","doi-asserted-by":"publisher","first-page":"e70","DOI":"10.1164\/rccm.201908-1590ST","volume":"200","author":"BL Graham","year":"2019","unstructured":"Graham, B. L. et al. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am. J. Respir Crit. Care Med. 200, e70\u2013e88. https:\/\/doi.org\/10.1164\/rccm.201908-1590ST (2019).","journal-title":"Am. J. Respir Crit. Care Med."},{"key":"41209_CR21","doi-asserted-by":"publisher","first-page":"211","DOI":"10.1080\/0269920042000193599","volume":"18","author":"EM Yiu","year":"2004","unstructured":"Yiu, E. M. & Ng, C. Y. Equal appearing interval and visual analogue scaling of perceptual roughness and breathiness. Clin. Linguist Phon. 18, 211\u2013229. https:\/\/doi.org\/10.1080\/0269920042000193599 (2004).","journal-title":"Clin. Linguist Phon"},{"key":"41209_CR22","doi-asserted-by":"publisher","first-page":"3620","DOI":"10.1007\/978-94-007-0753-5_1654","volume-title":"Encyclopedia of Quality of Life and Well-Being Research","author":"J Robinson","year":"2014","unstructured":"Robinson, J. Likert Scale. In: (ed Michalos, A. C.) Encyclopedia of Quality of Life and Well-Being Research. Springer Netherlands, Dordrecht, 3620\u20133621 (2014)."},{"key":"41209_CR23","doi-asserted-by":"publisher","first-page":"103208","DOI":"10.1016\/j.jbi.2019.103208","volume":"95","author":"PA Harris","year":"2019","unstructured":"Harris, P. A. et al. The REDCap consortium: Building an international community of software platform partners. J. Biomed. Inf. 95, 103208. https:\/\/doi.org\/10.1016\/j.jbi.2019.103208 (2019).","journal-title":"J. Biomed. Inf."},{"key":"41209_CR24","doi-asserted-by":"publisher","first-page":"377","DOI":"10.1016\/j.jbi.2008.08.010","volume":"42","author":"PA Harris","year":"2009","unstructured":"Harris, P. A. et al. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J. Biomed. Inf. 42, 377\u2013381. https:\/\/doi.org\/10.1016\/j.jbi.2008.08.010 (2009).","journal-title":"J. Biomed. Inf."},{"key":"41209_CR25","doi-asserted-by":"publisher","first-page":"e44","DOI":"10.1097\/SCS.0000000000009774","volume":"35","author":"Y Kanno","year":"2024","unstructured":"Kanno, Y., Hasegawa, O. & Kawase-Koga, Y. A Novel Dressing Method to Achieve Early Natural Tracheostoma Closure. J. Craniofac. Surg. 35, e44\u2013e45. https:\/\/doi.org\/10.1097\/SCS.0000000000009774 (2024).","journal-title":"J. Craniofac. Surg."},{"key":"41209_CR26","doi-asserted-by":"publisher","first-page":"185","DOI":"10.5005\/jp-journals-11010-02104","volume":"2","author":"JK Sreedharan","year":"2022","unstructured":"Sreedharan, J. K., Nair, S. G. & Vazhakatt, J. D. Basic principles of respiratory care for patients with tracheostomy. Indian J. Respiratory Care. 2, 185\u2013193. https:\/\/doi.org\/10.5005\/jp-journals-11010-02104 (2022).","journal-title":"Indian J. Respiratory Care"},{"key":"41209_CR27","doi-asserted-by":"publisher","first-page":"5297","DOI":"10.21037\/jtd-2019-ipicu-13","volume":"13","author":"S Alsunaid","year":"2021","unstructured":"Alsunaid, S. et al. Wound care management: tracheostomy and gastrostomy. J. Thorac. Dis. 13, 5297\u20135313. https:\/\/doi.org\/10.21037\/jtd-2019-ipicu-13 (2021).","journal-title":"J. Thorac. Dis."},{"key":"41209_CR28","doi-asserted-by":"publisher","first-page":"431","DOI":"10.1044\/2021_JSLHR-21-00308","volume":"65","author":"JC Borders","year":"2022","unstructured":"Borders, J. C. & Troche, M. S. Voluntary Cough Effectiveness and Airway Clearance in Neurodegenerative Disease. J. Speech Lang. Hear. Res. 65, 431\u2013449. https:\/\/doi.org\/10.1044\/2021_JSLHR-21-00308 (2022).","journal-title":"J. Speech Lang. Hear. Res."},{"key":"41209_CR29","doi-asserted-by":"publisher","first-page":"511","DOI":"10.1121\/1.396829","volume":"84","author":"EB Holmberg","year":"1988","unstructured":"Holmberg, E. B., Hillman, R. E. & Perkell, J. S. Glottal airflow and transglottal air pressure measurements for male and female speakers in soft, normal, and loud voice. J. Acoust. Soc. Am. 84, 511\u2013529. https:\/\/doi.org\/10.1121\/1.396829 (1988).","journal-title":"J. Acoust. Soc. Am."},{"key":"41209_CR30","first-page":"A4481","volume":"59","author":"F Mondrup","year":"2012","unstructured":"Mondrup, F., Skjelsager, K. & Madsen, K. R. Inadequate follow-up after tracheostomy and intensive care. Dan. Med. J. 59, A4481 (2012).","journal-title":"Dan. Med. J."},{"key":"41209_CR31","doi-asserted-by":"publisher","first-page":"e314","DOI":"10.1017\/S0950268819001900","volume":"147","author":"K Kaier","year":"2019","unstructured":"Kaier, K. et al. Impact of mechanical ventilation on the daily costs of ICU care: a systematic review and meta regression. Epidemiol. Infect. 147, e314. https:\/\/doi.org\/10.1017\/S0950268819001900 (2019).","journal-title":"Epidemiol. Infect."},{"key":"41209_CR32","doi-asserted-by":"publisher","first-page":"e0523","DOI":"10.1097\/CCE.0000000000000523","volume":"3","author":"MK Abril","year":"2021","unstructured":"Abril, M. K. et al. The Epidemiology of Adult Tracheostomy in the United States 2002\u20132017: A Serial Cross-Sectional Study. Crit. Care Explorations. 3, e0523. https:\/\/doi.org\/10.1097\/CCE.0000000000000523 (2021).","journal-title":"Crit. Care Explorations"}],"container-title":["Scientific Reports"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.nature.com\/articles\/s41598-026-41209-8","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.nature.com\/articles\/s41598-026-41209-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.nature.com\/articles\/s41598-026-41209-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,12]],"date-time":"2026-05-12T20:01:24Z","timestamp":1778616084000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.nature.com\/articles\/s41598-026-41209-8"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,3,24]]},"references-count":32,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2026,12]]}},"alternative-id":["41209"],"URL":"https:\/\/doi.org\/10.1038\/s41598-026-41209-8","relation":{},"ISSN":["2045-2322"],"issn-type":[{"value":"2045-2322","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,3,24]]},"assertion":[{"value":"26 October 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"18 February 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"24 March 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"KJC holds a patent for the sealing disc prototype. JHM, KJC, and Technolution A\/S are co-owners of IntraCair ApS, working to commercialize the sealing disc prototype. AEK, LWN, ND, REK, and SD declare no competing interests.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"14800"}}