{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,16]],"date-time":"2025-12-16T11:40:46Z","timestamp":1765885246540,"version":"3.48.0"},"reference-count":27,"publisher":"BMJ","issue":"6","license":[{"start":{"date-parts":[[2025,6,19]],"date-time":"2025-06-19T00:00:00Z","timestamp":1750291200000},"content-version":"unspecified","delay-in-days":18,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Hamilton academic Health Sciences Organization","award":["HAHSO AFP INNOVATION GRANT COMPETITION 2021\/22"],"award-info":[{"award-number":["HAHSO AFP INNOVATION GRANT COMPETITION 2021\/22"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,6,2]]},"published-print":{"date-parts":[[2025,6]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>\n                      The cuff leak test (CLT) is hypothesised to help optimise extubation by assessing for laryngeal oedema which, if unrecognised and untreated, could lead to post-extubation stridor, post-extubation airway obstruction, and reintubation. However, the diagnostic accuracy of the CLT to detect post-extubation stridor (and hence potentially airway obstruction) remains uncertain. Given the equipoise that exists surrounding the CLT, we are conducting a pilot randomised clinical trial (RCT) examining the CLT as part of the pathway to extubation. Herein, we report the protocol for the\n                      <jats:underline>C<\/jats:underline>\n                      uff Leak Test and Airway\n                      <jats:underline>O<\/jats:underline>\n                      b\n                      <jats:underline>s<\/jats:underline>\n                      truction in\n                      <jats:underline>M<\/jats:underline>\n                      echanically Ventilated\n                      <jats:underline>IC<\/jats:underline>\n                      U Patients (COSMIC): a Pilot Feasibility Randomized Clinical trial (RCT).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This is a multicentre, international, parallel-group, pragmatic, pilot RCT. We will enrol 100 mechanically ventilated patients in the intensive care unit (ICU) who are deemed ready for extubation and have at least one risk factor for laryngeal oedema. In the intervention arm, respiratory therapists will perform a qualitative CLT before extubation. If a patient passes the CLT (suggesting no laryngeal oedema), extubation will be performed in keeping with standard care. If the patient fails the CLT (suggesting laryngeal oedema), extubation will be delayed allowing for administration of dexamethasone, consideration of diuresis, and the CLT will be repeated in 12\u201324\u2009hours. In the control arm, patients will be extubated without completing a CLT, without steroid administration, and without delay. Randomization will be by a 1:1 allocation, stratified by centre. The primary feasibility outcomes will include recruitment and protocol adherence. Secondary outcomes will include post-extubation stridor, reintubation within 72 hours, emergency surgical airway within 72 hours, and ICU and hospital mortality within 30 days.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>This trial has been approved by Clinical Trials Ontario, Hamilton Integrated Research Ethics Board, State of Kuwait Ministry of Health, University of Texas Health Committee for the Protection of Human Subjects and Brant Community Health Systems Research Ethics Committee. The trial has received a No Objection Letter from Health Canada. Trial results will be disseminated via publication in peer-reviewed journals.<\/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\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT05456542\">NCT05456542<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2024-096053","type":"journal-article","created":{"date-parts":[[2025,6,19]],"date-time":"2025-06-19T06:58:32Z","timestamp":1750316312000},"page":"e096053","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["Cuff leak test and airway obstruction in mechanically ventilated ICU patients (COSMIC): a pilot feasibility randomized controlled trial protocol"],"prefix":"10.1136","volume":"15","clinical-trial-number":[{"clinical-trial-number":"nct05456542","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct05456542","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Jose","family":"Estrada","sequence":"first","affiliation":[{"name":"The Research Institute of St Joe\u2019s Hamilton, Hamilton, Ontario, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Irene","family":"Armanious","sequence":"additional","affiliation":[{"name":"The Research Institute of St Joe\u2019s Hamilton, Hamilton, Ontario, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dan","family":"Perri","sequence":"additional","affiliation":[{"name":"The Research Institute of St Joe\u2019s Hamilton, Hamilton, Ontario, Canada"},{"name":"Department of Medicine, McMaster University, Hamilton, Ontario, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4087-543X","authenticated-orcid":false,"given":"Deborah J","family":"Cook","sequence":"additional","affiliation":[{"name":"The Research Institute of St Joe\u2019s Hamilton, Hamilton, Ontario, Canada"},{"name":"Department of Medicine, McMaster University, Hamilton, Ontario, Canada"},{"name":"Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-3573-7754","authenticated-orcid":false,"given":"Erick Huaileigh","family":"Duan","sequence":"additional","affiliation":[{"name":"The Research Institute of St Joe\u2019s Hamilton, Hamilton, Ontario, Canada"},{"name":"Department of Medicine, McMaster University, Hamilton, Ontario, Canada"},{"name":"Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karen","family":"Bosma","sequence":"additional","affiliation":[{"name":"Critical Care Western, Department of Medicine, University of Western Ontario, London, Ontario, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kelly","family":"Hassall","sequence":"additional","affiliation":[{"name":"St Joseph\u2019s Healthcare Hamilton, Hamilton, Ontario, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Corry","family":"Marchildon","sequence":"additional","affiliation":[{"name":"St Joseph\u2019s Healthcare Hamilton, Hamilton, Ontario, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sangeeta","family":"Mehta","sequence":"additional","affiliation":[{"name":"Department of Medicine, Sinai Health System; Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Roman","family":"Jaeschke","sequence":"additional","affiliation":[{"name":"The Research Institute of St Joe\u2019s Hamilton, Hamilton, Ontario, Canada"},{"name":"Department of Medicine, McMaster University, Hamilton, Ontario, Canada"},{"name":"Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas","family":"Piraino","sequence":"additional","affiliation":[{"name":"St Michael\u2019s Hospital, Toronto, Ontario, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9041-9216","authenticated-orcid":false,"given":"Kallirroi Laiya","family":"Carayannopoulos","sequence":"additional","affiliation":[{"name":"The Research Institute of St Joe\u2019s Hamilton, Hamilton, Ontario, Canada"},{"name":"Department of Medicine, McMaster University, Hamilton, Ontario, Canada"},{"name":"Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Waleed","family":"Alhazzani","sequence":"additional","affiliation":[{"name":"Critical Care and Internal Medicine Department, College of Medicine, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia"},{"name":"Health Research Center, Ministry of Defense Health Services, Riyadh, Saudi Arabia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-5734-4096","authenticated-orcid":false,"given":"Kimberley","family":"Lewis","sequence":"additional","affiliation":[{"name":"The Research Institute of St Joe\u2019s Hamilton, Hamilton, Ontario, Canada"},{"name":"Department of Medicine, McMaster University, Hamilton, Ontario, Canada"},{"name":"Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2025,6,19]]},"reference":[{"key":"2025121603382923000_15.6.e096053.1","doi-asserted-by":"crossref","first-page":"23","DOI":"10.1016\/j.jcrc.2004.02.005","article-title":"How to identify patients with no risk for postextubation stridor?","volume":"19","author":"Maury","year":"2004","journal-title":"J Crit Care"},{"key":"2025121603382923000_15.6.e096053.2","doi-asserted-by":"publisher","DOI":"10.1007\/s00134-010-1847-z"},{"key":"2025121603382923000_15.6.e096053.3","doi-asserted-by":"crossref","first-page":"675","DOI":"10.1016\/j.jcrc.2013.05.011","article-title":"Predicting laryngeal edema in intubated patients by portable intensive care unit ultrasound","volume":"28","author":"Sutherasan","year":"2013","journal-title":"J Crit Care"},{"key":"2025121603382923000_15.6.e096053.4","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(07)60526-1"},{"key":"2025121603382923000_15.6.e096053.5","doi-asserted-by":"crossref","first-page":"242","DOI":"10.1111\/j.1756-5391.2011.01160.x","article-title":"Cuff-leak test for predicting postextubation airway complications: a systematic review","volume":"4","author":"Zhou","year":"2011","journal-title":"J Evid Based Med"},{"key":"2025121603382923000_15.6.e096053.6","doi-asserted-by":"publisher","DOI":"10.1164\/ajrccm.158.2.9711045"},{"key":"2025121603382923000_15.6.e096053.7","doi-asserted-by":"publisher","DOI":"10.1097\/00003246-198806000-00001"},{"key":"2025121603382923000_15.6.e096053.8","doi-asserted-by":"publisher","DOI":"10.1164\/ajrccm.156.2.9610109"},{"key":"2025121603382923000_15.6.e096053.9","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcrc.2010.12.015"},{"key":"2025121603382923000_15.6.e096053.10","doi-asserted-by":"publisher","DOI":"10.1164\/ajrccm.152.1.7599812"},{"key":"2025121603382923000_15.6.e096053.11","doi-asserted-by":"publisher","DOI":"10.1186\/cc2913"},{"key":"2025121603382923000_15.6.e096053.12","doi-asserted-by":"crossref","first-page":"120","DOI":"10.1164\/rccm.201610-2075ST","article-title":"An Official American Thoracic Society\/American College of Chest Physicians Clinical Practice Guideline: Liberation from Mechanical Ventilation in Critically Ill Adults. 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