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Multicenter prospective study conducted in five adult intensive care units in the UK. Following screening and assent, intubated patients mechanically ventilated for\u2009&gt;\u200924 h were randomized to intervention or usual care. Intervention consisted of application of the BEACON Caresystem\u2019s advice on tidal volume\/inspiratory pressure, inspired oxygen, respiratory rate and PEEP. Usual care was defined as local clinical practice. The primary outcome was duration of mechanical ventilation. Secondary outcomes quantified prolonged intubation and survival; adverse events; ventilator settings and physiological state; time spent in ventilator modes; links to other therapy; the frequency of advice utilization and time spent outside normal physiological limits. The study was terminated early with a total of 112 patients included. Fifty-four were randomised to the intervention arm and fifty-eight to usual care. The study was underpowered and no significant differences were seen in duration of mechanical ventilation (p\u2009=\u20090.773), prolonged intubation or survival. Intervention arm patients had lower rates of adverse events (p\u2009=\u20090.016), including fewer hypoxaemic events (p\u2009=\u20090.008) and lower values of PEEP (p\u2009=\u20090.030) and tidal volume (p\u2009=\u20090.042). Values of peak inspiratory pressure and pressure support were reduced but at the boarder of statistical significance (p\u2009=\u20090.104, p\u2009=\u20090.093, respectively). No differences were seen for time in ventilator mode or other therapy. Advice presented by the decision support system was applied at the beside an average of 88% of occasions, with a significantly increased number of changes only in inspired oxygen fraction. No significant differences were seen in time spent outside physiological limits. This study investigated the use of the BEACON Caresystem, an open loop clinical decision support system providing advice on ventilator settings. It was terminated early, with no significant difference shown in duration of mechanical ventilation, the primary outcome. Application of advice indicated potential for fewer adverse events and improved physiological status. (<jats:italic>Trial registration<\/jats:italic> ClinicalTrials.gov under NCT03249623. Registered 22nd June 2017)<\/jats:p>","DOI":"10.1007\/s10877-024-01231-5","type":"journal-article","created":{"date-parts":[[2024,11,9]],"date-time":"2024-11-09T10:33:05Z","timestamp":1731148385000},"page":"393-404","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Evaluation of decision support to wean patients from mechanical ventilation in intensive care: a prospective study reporting clinical and physiological outcomes"],"prefix":"10.1007","volume":"39","clinical-trial-number":[{"clinical-trial-number":"nct03249623","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Marcela P.","family":"Vizcaychipi","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dan S.","family":"Karbing","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura","family":"Martins","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amandeep","family":"Gupta","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jeronimo","family":"Moreno-Cuesta","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Manu","family":"Naik","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ingeborg","family":"Welters","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Suveer","family":"Singh","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Georgina","family":"Randell","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Leyla","family":"Osman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephen E.","family":"Rees","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2024,11,9]]},"reference":[{"key":"1231_CR1","doi-asserted-by":"publisher","first-page":"1301","DOI":"10.1056\/NEJM200005043421801","volume":"342","author":"RG Brower","year":"2000","unstructured":"Brower RG, Matthay MA, Acute Respiratory Distress Syndrome Network, et al. 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SR and DSK have previously been minor shareholders of Mermaid Care A\/S who manufactured the BEACON Caresystem, but no longer have any association with the current owners of the commercial rights to the system and as such would not benefit from future commercialisation.  Mermaid Care provided study funding, training in use of the system and technical support during the study. Mermaid Care had access to data, blinded by arm, for internal quality control and regulatory issues, but had no role in data analysis for this manuscript.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"Ethical approval was obtained from the regional ethics committee of the HRC (Date 22\/08\/17, REC reference 17\/LO\/0997, IRAS reference 226,610) and was prospectively registered (ClinicalTrials.gov ID: NCT03249623). This study was also registered with the National Institute for Health Research (NIHR) (CPMS ID: 34,831) and endorsed by the European Society for Intensive Care Medicine (ESICM). The study was conducted in compliance with the Declaration of Helsinki, the Code of Ethics of the World Medical Association for experiments involving humans and Local Regulatory Requirements. Five clinical sites in the UK were involved in patient recruitment, with sites added during the study period. These were located at the Chelsea and Westminster Hospital (CW), West Middlesex University Hospital (WM), North Middlesex University Hospital (NM), Norwich and Norfolk University Hospital (NN), and Liverpool University Hospital (LU). Safety oversight was under the direction of an independent committee coordinated by the Research & Development team at Chelsea & Westminster NHS Foundation Trust.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"All patients were screened for eligibility on admission to the ICU by the research team. Following screening, consent was obtained either from the patient where capable, a relative\/personal consultee, or if not possible, a nominated professional consultee from outside the research group. Patients were randomized into the intervention arm, where BC advice was available, or to usual care (see ESM, Fig. S.1.1). Patients were included if adult, had\u2009>\u200924 h invasive mechanical ventilation; if the ventilator and mode was supported by the BC; and if haemodynamically stable. Patients were excluded according to the criteria in the ESM (ESM S.4), which includes: history of home ventilation or multiple ICU admissions; if catagorised as patient with a primary neurological disorder or with head trauma; on the presence of severe heart failure, end stage liver disease or morbid obesity; or if clinical conditions required treatment with ECMO. Patients randomized to either arm were connected to the BC system via a flow and gas sensor connection placed in the main ventilation flow to and from the patient (see Measurements).","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to publish\/participate"}}]}}