{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,10]],"date-time":"2026-06-10T06:23:48Z","timestamp":1781072628992,"version":"3.54.1"},"reference-count":46,"publisher":"BMJ","issue":"5","license":[{"start":{"date-parts":[[2025,5,20]],"date-time":"2025-05-20T00:00:00Z","timestamp":1747699200000},"content-version":"unspecified","delay-in-days":19,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"University Hospital of Clermont-Ferrand, Clermont-Ferrand, France"},{"name":"French Ministry of Health"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,4,30]]},"published-print":{"date-parts":[[2025,5]]},"abstract":"<jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>Intensive care units (ICUs) manage patients with or likely to have one or more life-threatening acute organ failures that might require the use of invasive supportive therapies. The use of physical restraint is frequent, with rates up to 50%, and usually initiated to maintain patient safety especially if the patient is agitated. Physical restraints have been associated with delirium, post-traumatic stress disorder and physical injuries while restricting patients\u2019 individual freedom. Moreover, the incidence of invasive therapeutic devices\u2019 self-removal by patients might not be decreased by physical restraint use. No recommendation is available concerning ICU patients and physical restraint management, despite being a daily practice. The main objective is to evaluate whether a strategy aimed at decreasing physical restraint use in ICU patients with that of a strategy based on routine and subjective caregivers\u2019 decision is safe and efficient.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and analysis<\/jats:title>\n                  <jats:p>ARBORea is a multicentre randomised, stepped-wedge trial testing an innovative, dedicated web-based, multiprofessionally developed, experts validated, nursing management strategy in comparison with standard care. The primary outcome is physical restraint use rate (effectiveness) measured at least every 8\u2009hours and incidents\u2019 rate (tolerance) defined as the rate of incidents attributable to non-compliance, corresponding to the deterioration or self-removal of critical devices, a fall or self-aggressive or heteroaggressive behaviours. Planned enrolment is 4000 ICU adult participants at 20 French academic and non-academic centres. Safety and long-term outcomes will be evaluated.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Ethics and dissemination<\/jats:title>\n                  <jats:p>Trial results will be reported according to the Consolidated Standards of Reporting Trials 2010 guidelines. Findings will be published in peer-reviewed journals and presented at local, national and international meetings and conferences to publicise and explain the research to clinicians, commissioners and service users. The trial is funded by the French Ministry of Health and has been approved by the French local ethics committee (<jats:italic>Comit\u00e9 de Protection des Personnes Sud-Ouest et Outre-Mer 2<\/jats:italic>, Toulouse, France with registration number: 2020-A02904-35).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>(ClinicalTrials.gov) <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04957238\">NCT04957238<\/jats:ext-link> on 12 July 2021 before first inclusion in study.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjopen-2024-085674","type":"journal-article","created":{"date-parts":[[2025,5,21]],"date-time":"2025-05-21T09:25:15Z","timestamp":1747819515000},"page":"e085674","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":2,"title":["Stepped wedge cluster randomised controlled trial to assess the impact of a decision support tool for physical restraint use in intensive care units (ARBORea Study): a study protocol"],"prefix":"10.1136","volume":"15","clinical-trial-number":[{"clinical-trial-number":"nct04957238","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04957238","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2600-1138","authenticated-orcid":false,"given":"P\u00e9rine","family":"Vidal","sequence":"first","affiliation":[{"name":"Department of Anesthesiology, Critical Care and Perioperative Medicine, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C\u00e9line","family":"Lambert","sequence":"additional","affiliation":[{"name":"Biostatistics Unit, DRCI, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, 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France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christine","family":"Rolhion","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, Critical Care and Perioperative Medicine, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dominique","family":"Morand","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, Critical Care and Perioperative Medicine, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, France"},{"name":"Biostatistics Unit, DRCI, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sylvie","family":"Cosserant","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, Critical Care and Perioperative Medicine, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isabelle","family":"Gen\u00e8s","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, Critical Care and Perioperative Medicine, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9667-3407","authenticated-orcid":false,"given":"Thomas","family":"Godet","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, Critical Care and Perioperative Medicine, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, France"},{"name":"Inserm, Neuro-Dol, Clermont Auvergne University, 63000 Clermont-Ferrand, France"},{"name":"Department of Healthcare Simulation, Clermont Auvergne University, 63000 Clermont-Ferrand, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angelina","family":"Barage","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, Critical 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