{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,2]],"date-time":"2026-06-02T13:57:34Z","timestamp":1780408654261,"version":"3.54.1"},"reference-count":25,"publisher":"SAGE Publications","issue":"1","license":[{"start":{"date-parts":[[2023,6,23]],"date-time":"2023-06-23T00:00:00Z","timestamp":1687478400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/100000049","name":"National Institute on Aging","doi-asserted-by":"publisher","award":["K76AG059936"],"award-info":[{"award-number":["K76AG059936"]}],"id":[{"id":"10.13039\/100000049","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000049","name":"National Institute on Aging","doi-asserted-by":"publisher","award":["R42AG059451"],"award-info":[{"award-number":["R42AG059451"]}],"id":[{"id":"10.13039\/100000049","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Journal of the Intensive Care Society"],"published-print":{"date-parts":[[2024,2]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Mechanically ventilated Intensive Care Unit (ICU) patients often require wrist restraints, contributing to immobility and agitation, over-sedation, and delirium. The Exersides\u00ae Refraint\u00ae (Healthy Design, LLC), a novel restraint alternative, may be safe and facilitate greater mobility than traditional restraints.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>This National Institutes of Health Small Business Technology Transfer (STTR) Program Grant-funded single-site Phase I feasibility study evaluated Exersides\u00ae safety and feasibility in anticipation of a multi-site Phase II randomized controlled trial (RCT).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>In two academic ICUs, mechanically ventilated adults \u2a7e25\u2009years old who were non-comatose, required restraints and had an expected stay of \u2a7e2\u2009days were enrolled to wear Exersides\u00ae and traditional wrist restraints for 4\u2009h on day 1, in a randomized order, and in the reverse order on day 2. Main outcomes were Exersides\u00ae safety (i.e., patient\/clinician lacerations\/injuries), feasibility (i.e., \u2a7e90% of required data collected), and patient\/family\/clinician feedback.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Eight patients were enrolled; one no longer required restraints at initiation, yielding seven subjects (median [interquartile range (IQR)] age 65 [55, 70] years, 86% men). All seven wore Exersides\u00ae, averaging (SD) 2.5 (1.0) hours per session, with no safety events reported. Across restraint time periods, 92% and 100% of Richmond Agitation-Sedation Scale (RASS) and wrist actigraphy data, respectively, were collected. Feedback was positive (more movement and comfortable than traditional restraints) and constructive (bulky, intimidating to apply).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>This pilot study provided key safety and feasibility data for a Phase II RCT evaluating Exersides\u00ae versus traditional wrist restraints. Feedback motivated minor device modifications before RCT initiation.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/17511437231182503","type":"journal-article","created":{"date-parts":[[2023,6,24]],"date-time":"2023-06-24T13:15:14Z","timestamp":1687612514000},"page":"24-29","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":3,"title":["Phase I pilot safety and feasibility of a novel restraint device for critically ill patients requiring mechanical ventilation"],"prefix":"10.1177","volume":"25","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9245-6229","authenticated-orcid":false,"given":"Biren B","family":"Kamdar","sequence":"first","affiliation":[{"name":"Division of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego School of Medicine, La Jolla, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6800-4222","authenticated-orcid":false,"given":"Janelle M","family":"Fine","sequence":"additional","affiliation":[{"name":"Division of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego School of Medicine, La Jolla, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marie T","family":"Pavini","sequence":"additional","affiliation":[{"name":"Healthy Design Ltd. Co., Rutland, VT, USA"},{"name":"Pulmonary and Critical Care Medicine, University of Vermont Larner College of Medicine, Burlington, VT, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara S","family":"Ardren","sequence":"additional","affiliation":[{"name":"Pulmonary and Critical Care Medicine, University of Vermont Larner College of Medicine, Burlington, VT, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephanie","family":"Burns","sequence":"additional","affiliation":[{"name":"Pulmonary and Critical Care Medicine, University of Vermont Larner College of Medicine, Burlington, VT, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jason HT","family":"Bates","sequence":"additional","affiliation":[{"name":"Pulmonary and Critical Care Medicine, University of Vermont Larner College of Medicine, Burlington, VT, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryan 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