{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,18]],"date-time":"2026-06-18T07:01:29Z","timestamp":1781766089639,"version":"3.54.5"},"reference-count":64,"publisher":"National Institute for Health and Care Research","issue":"48","license":[{"start":{"date-parts":[[2019,9,1]],"date-time":"2019-09-01T00:00:00Z","timestamp":1567296000000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/www.nationalarchives.gov.uk\/doc\/non-commercial-government-licence\/non-commercial-government-licence.htm"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment programme","doi-asserted-by":"publisher","award":["10\/134\/06"],"award-info":[{"award-number":["10\/134\/06"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"\n Background<\/jats:title>\n Invasive mechanical ventilation (IMV) is a life-saving intervention. Following resolution of the condition that necessitated IMV, a spontaneous breathing trial (SBT) is used to determine patient readiness for IMV discontinuation. In patients who fail one or more SBTs, there is uncertainty as to the optimum management strategy.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To evaluate the clinical effectiveness and cost-effectiveness of using non-invasive ventilation (NIV) as an intermediate step in the protocolised weaning of patients from IMV.<\/jats:p>\n <\/jats:sec>\n \n Design<\/jats:title>\n Pragmatic, open-label, parallel-group randomised controlled trial, with cost-effectiveness analysis.<\/jats:p>\n <\/jats:sec>\n \n Setting<\/jats:title>\n A total of 51 critical care units across the UK.<\/jats:p>\n <\/jats:sec>\n \n Participants<\/jats:title>\n Adult intensive care patients who had received IMV for at least 48 hours, who were categorised as ready to wean from ventilation, and who failed a SBT.<\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n Control group (invasive weaning): patients continued to receive IMV with daily SBTs. A weaning protocol was used to wean pressure support based on the patient\u2019s condition. Intervention group (non-invasive weaning): patients were extubated to NIV. A weaning protocol was used to wean inspiratory positive airway pressure, based on the patient\u2019s condition.<\/jats:p>\n <\/jats:sec>\n \n Main outcome measures<\/jats:title>\n The primary outcome measure was time to liberation from ventilation. Secondary outcome measures included mortality, duration of IMV, proportion of patients receiving antibiotics for a presumed respiratory infection and health-related quality of life.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n A total of 364 patients (invasive weaning, n<\/jats:italic>\u2009=\u2009182; non-invasive weaning, n<\/jats:italic>\u2009=\u2009182) were randomised. Groups were well matched at baseline. There was no difference between the invasive weaning and non-invasive weaning groups in median time to liberation from ventilation {invasive weaning 108 hours [interquartile range (IQR) 57\u2013351 hours] vs. non-invasive weaning 104.3 hours [IQR 34.5\u2013297 hours]; hazard ratio 1.1, 95% confidence interval [CI] 0.89 to 1.39; p<\/jats:italic>\u2009=\u20090.352}. There was also no difference in mortality between groups at any time point. Patients in the non-invasive weaning group had fewer IMV days [invasive weaning 4 days (IQR 2\u201311 days) vs. non-invasive weaning 1 day (IQR 0\u20137 days); adjusted mean difference \u20133.1 days, 95% CI \u20135.75 to \u20130.51 days]. In addition, fewer non-invasive weaning patients required antibiotics for a respiratory infection [odds ratio (OR) 0.60, 95% CI 0.41 to 1.00; p<\/jats:italic>\u2009=\u20090.048]. A higher proportion of non-invasive weaning patients required reintubation than those in the invasive weaning group (OR 2.00, 95% CI 1.27 to 3.24). The within-trial economic evaluation showed that NIV was associated with a lower net cost and a higher net effect, and was dominant in health economic terms. The probability that NIV was cost-effective was estimated at 0.58 at a cost-effectiveness threshold of \u00a320,000 per quality-adjusted life-year.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n A protocolised non-invasive weaning strategy did not reduce time to liberation from ventilation. However, patients who underwent non-invasive weaning had fewer days requiring IMV and required fewer antibiotics for respiratory infections.<\/jats:p>\n <\/jats:sec>\n \n Future work<\/jats:title>\n In patients who fail a SBT, which factors predict an adverse outcome (reintubation, tracheostomy, death) if extubated and weaned using NIV?<\/jats:p>\n <\/jats:sec>\n \n Trial registration<\/jats:title>\n Current Controlled Trials ISRCTN15635197.<\/jats:p>\n <\/jats:sec>\n \n Funding<\/jats:title>\n This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment<\/jats:italic>; Vol. 23, No. 48. See the NIHR Journals Library website for further project information.<\/jats:p>\n <\/jats:sec>","DOI":"10.3310\/hta23480","type":"journal-article","created":{"date-parts":[[2019,9,18]],"date-time":"2019-09-18T14:08:23Z","timestamp":1568815703000},"page":"1-114","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":12,"title":["Protocolised non-invasive compared with invasive weaning from mechanical ventilation for adults in intensive care: the Breathe RCT"],"prefix":"10.3310","volume":"23","clinical-trial-number":[{"clinical-trial-number":"isrctn15635197","registry":"10.18810\/isrctn","type":"results"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3027-7548","authenticated-orcid":true,"given":"Gavin D","family":"Perkins","sequence":"first","affiliation":[{"name":"Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK"},{"name":"Critical Care Unit, Heartlands Hospital, University Hospitals 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