{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T23:14:04Z","timestamp":1790723644920,"version":"4.1.0"},"reference-count":30,"publisher":"BMJ","issue":"8","license":[{"start":{"date-parts":[[2025,8,26]],"date-time":"2025-08-26T00:00:00Z","timestamp":1756166400000},"content-version":"unspecified","delay-in-days":25,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,7,28]]},"published-print":{"date-parts":[[2025,8]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Intensive care unit-acquired weakness (ICU-AW) is a common complication in critically ill patients, with an incidence of approximately 50% in the ICU. It is closely associated with increased morbidity, physical deterioration and higher short-term and long-term mortality. Its main characteristics include generalised and symmetrical muscle weakness affecting both respiratory and limb muscles. Early mobilisation has been identified as a feasible intervention in critically ill patients to mitigate the effects of ICU-AW. However, the incidence and nature of potential adverse events associated with its implementation are not yet well established. Therefore, this study aims to evaluate the safety outcomes in a cohort of patients undergoing early mobilisation in the ICU.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This is a prospective, multicentre, observational cohort study that will be conducted between June and December 2025 in four high-complexity ICUs in Bogot\u00e1, Colombia. The study will enrol 135 consecutive adult patients (\u226518 years) admitted to the ICU who meet the eligibility criteria. Recruitment will follow a non-probabilistic, consecutive sampling approach in which all eligible patients will be included as they are admitted.<\/jats:p>\n                    <jats:p>At least 900 early mobilisation sessions are expected. Baseline sociodemographic and clinical data will be collected, and each session will be documented using a standardised form.<\/jats:p>\n                    <jats:p>The primary outcome is the occurrence of adverse events during early mobilisation sessions. These events will be classified as serious or non-serious and assessed by an independent committee to determine causality and preventability.<\/jats:p>\n                    <jats:p>Secondary outcomes include the total number of mobilisation sessions per patient and the highest level of mobility achieved, assessed using the ICU Mobility Scale (IMS).<\/jats:p>\n                    <jats:p>The analysis will include descriptive statistics, incidence of adverse events, session counts and IMS scores. A subgroup analysis will be conducted based on vasopressor use and dosage to explore potential differences in mobility outcomes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>\n                      Ethical approval has been obtained from the Fundaci\u00f3n Universitaria Sanitas Research Ethics Committee (CEIFUS 1347\u201324) Clinical Trials Registration number\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT06653998\">NCT06653998<\/jats:ext-link>\n                      . The findings will be disseminated in clinical trials study profile, in peer-reviewed journals and presentations at conferences.\n                    <\/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=\"NCT06653998\">NCT06653998<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-101772","type":"journal-article","created":{"date-parts":[[2025,8,26]],"date-time":"2025-08-26T14:25:37Z","timestamp":1756218337000},"page":"e101772","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["Safety of early mobilisation in the intensive care unit: a prospective and multicentre cohort study protocol"],"prefix":"10.1136","volume":"15","clinical-trial-number":[{"clinical-trial-number":"nct06653998","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct06653998","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0009-0008-9749-2596","authenticated-orcid":false,"given":"Henry Mauricio","family":"Parada-Gereda","sequence":"first","affiliation":[{"name":"Cl\u00ednica Colsanitas S.A, Bogot\u00e1, Colombia"},{"name":"Cl\u00ednica Reina Sof\u00eda, Bogot\u00e1, Colombia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ricardo","family":"Merch\u00e1n-Chaverra","sequence":"additional","affiliation":[{"name":"Cl\u00ednica Colsanitas S.A, Bogot\u00e1, Colombia"},{"name":"Fundacion Universitaria Sanitas, Bogot\u00e1, Colombia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jorge","family":"Medina-Parra","sequence":"additional","affiliation":[{"name":"Cl\u00ednica Colsanitas S.A, Bogot\u00e1, Colombia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johana","family":"Benavides-Cruz","sequence":"additional","affiliation":[{"name":"Fundacion Universitaria Sanitas, Bogot\u00e1, Colombia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hernando","family":"Gait\u00e1n-Duarte","sequence":"additional","affiliation":[{"name":"Universidad Nacional de Colombia, Bogot\u00e1, Colombia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2025,8,26]]},"reference":[{"key":"2025123106474128000_15.8.e101772.1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ccc.2007.11.002"},{"key":"2025123106474128000_15.8.e101772.2","doi-asserted-by":"publisher","DOI":"10.1097\/CCM.0b013e3181a38937"},{"key":"2025123106474128000_15.8.e101772.3","doi-asserted-by":"publisher","DOI":"10.1007\/s00134-007-0772-2"},{"key":"2025123106474128000_15.8.e101772.4","article-title":"Interventions for preventing critical illness polyneuropathy and critical illness myopathy","volume":"2014","author":"Hermans","year":"2014","journal-title":"Cochrane Database Syst Rev"},{"key":"2025123106474128000_15.8.e101772.5","doi-asserted-by":"crossref","DOI":"10.1186\/s40560-023-00670-7","article-title":"Post-intensive care syndrome (PICS): recent updates","volume":"11","author":"Hiser","year":"2023","journal-title":"J Intensive Care"},{"key":"2025123106474128000_15.8.e101772.6","doi-asserted-by":"publisher","DOI":"10.1097\/CCM.0b013e3181b6ef67"},{"key":"2025123106474128000_15.8.e101772.7","doi-asserted-by":"publisher","DOI":"10.1007\/s00134-017-4757-5"},{"key":"2025123106474128000_15.8.e101772.8","doi-asserted-by":"crossref","first-page":"37","DOI":"10.1097\/JAT.0000000000000140","article-title":"Early Mobilization of Patients Receiving Vasoactive Drugs in Critical Care Units: A Systematic Review","volume":"12","author":"Jacob","year":"2021","journal-title":"J Acute Care Phys Ther"},{"key":"2025123106474128000_15.8.e101772.9","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.201205-0954SO"},{"key":"2025123106474128000_15.8.e101772.10","doi-asserted-by":"publisher","DOI":"10.1001\/jama.288.22.2859"},{"key":"2025123106474128000_15.8.e101772.11","doi-asserted-by":"crossref","first-page":"199","DOI":"10.5935\/0103-507X.20150036","article-title":"A guided approach to diagnose severe muscle weakness in the intensive care unit","volume":"27","author":"Latronico","year":"2015","journal-title":"Rev Bras Ter Intensiva"},{"key":"2025123106474128000_15.8.e101772.12","doi-asserted-by":"publisher","DOI":"10.1097\/CCM.0b013e31827ca637"},{"key":"2025123106474128000_15.8.e101772.13","doi-asserted-by":"publisher","DOI":"10.1378\/chest.12-2930"},{"key":"2025123106474128000_15.8.e101772.14","doi-asserted-by":"crossref","first-page":"766","DOI":"10.1513\/AnnalsATS.201611-843SR","article-title":"Safety of Patient Mobilization and Rehabilitation in the Intensive Care Unit. 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