{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,7]],"date-time":"2026-08-07T16:33:10Z","timestamp":1786120390007,"version":"build-2736575974"},"reference-count":27,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"8","content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives:<\/jats:title>\n                    <jats:p>To evaluate a novel device, developed under a National Institutes of Health Small Business Technology Transfer program grant, designed as an alternative to traditional wrist restraints.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design:<\/jats:title>\n                    <jats:p>Within-patient crossover phase II randomized trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting:<\/jats:title>\n                    <jats:p>Four U.S. academic medical centers.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Patients:<\/jats:title>\n                    <jats:p>\n                      ICU patients (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      = 54) who were verbally responsive with a provider order for wrist restraints and expected stay greater than or equal to 2 days.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Interventions:<\/jats:title>\n                    <jats:p>Alternating use of novel device vs. traditional restraint during 4-hour assessment periods over 2 days (four assessment periods), with randomization of initial allocation to novel device vs. restraint.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Measurements and Main Results:<\/jats:title>\n                    <jats:p>\n                      Upper extremity activity (measured via wrist actigraphy) was the primary outcome, with safety, sedation, delirium, satisfaction (via Quebec User Evaluation of Satisfaction with Assistive Technology [QUEST] survey), and qualitative analyses of survey data as secondary outcomes. Analysis of actigraphy data demonstrated similar mean activity counts per 4-hour session for the novel device vs. traditional restraints, with a range of mean activity across the four sessions of 2930\u20134395 vs. 3898\u20134910, respectively, with relative mean total activity count per session of 0.93 (95% CI, 0.76\u20131.13;\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      = 0.45). Across 98 sessions using the novel device, 2 (2%) potential safety events were reported. No statistically significant differences were observed in sedation\/agitation, or delirium status and severity. Of the QUEST satisfaction surveys completed by patient\/family (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      = 25) and clinicians (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      = 79), 58% and 51%, respectively, indicated high satisfaction with qualitative analyses demonstrating four positive and six constructive themes.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>No differences in upper extremity activity, delirium, sedation, or agitation were demonstrated between the novel device and traditional wrist restraints. The novel device had overall moderate patient\/family and clinician satisfaction, and qualitative analyses provide important insights for advancing the development of novel restraint alternative devices.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1097\/ccm.0000000000007172","type":"journal-article","created":{"date-parts":[[2026,5,28]],"date-time":"2026-05-28T14:00:10Z","timestamp":1779976810000},"page":"1859-1869","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":0,"title":["Reducing Physical Restraint in the ICU: Multicenter Phase II Randomized Trial of a Novel Device Versus Traditional Wrist Restraints"],"prefix":"10.1097","volume":"54","author":[{"given":"Renee D.","family":"Stapleton","sequence":"first","affiliation":[{"name":"Division of Pulmonary and Critical Care Medicine, University of Vermont Larner College of Medicine, Burlington, VT."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Biren B.","family":"Kamdar","sequence":"additional","affiliation":[{"name":"Division of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego School of Medicine, La Jolla, CA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth A.","family":"Colantuoni","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vinciya","family":"Pandian","sequence":"additional","affiliation":[{"name":"Ross and Carole Nese College of Nursing, The Pennsylvania State University, University Pare, PA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa Aronson","family":"Friedman","sequence":"additional","affiliation":[{"name":"Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jason H. 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