{"doi":"10.1177/17511437231182503","title":"Phase I pilot safety and feasibility of a novel restraint device for critically ill patients requiring mechanical ventilation","abstract":"Background: Mechanically ventilated Intensive Care Unit (ICU) patients often require wrist restraints, contributing to immobility and agitation, over-sedation, and delirium. The Exersides® Refraint® (Healthy Design, LLC), a novel restraint alternative, may be safe and facilitate greater mobility than traditional restraints. Objective: This National Institutes of Health Small Business Technology Transfer (STTR) Program Grant-funded single-site Phase I feasibility study evaluated Exersides® safety and feasibility in anticipation of a multi-site Phase II randomized controlled trial (RCT). Methods: In two academic ICUs, mechanically ventilated adults ⩾25 years old who were non-comatose, required restraints and had an expected stay of ⩾2 days were enrolled to wear Exersides® and traditional wrist restraints for 4 h on day 1, in a randomized order, and in the reverse order on day 2. Main outcomes were Exersides® safety (i.e., patient/clinician lacerations/injuries), feasibility (i.e., ⩾90% of required data collected), and patient/family/clinician feedback. Results: 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®, 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). Conclusions: This pilot study provided key safety and feasibility data for a Phase II RCT evaluating Exersides® versus traditional wrist restraints. Feedback motivated minor device modifications before RCT initiation.","journal":"Journal of the Intensive Care Society","year":2023,"id":375008,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":4,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.956,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2023-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":436258,"name":"Janelle M. Fine","orcid":"0000-0002-6800-4222","position":1,"is_corresponding":false},{"id":1137694,"name":"Marie T. Pavini","orcid":null,"position":2,"is_corresponding":false},{"id":1137695,"name":"Sara S. Ardren","orcid":null,"position":3,"is_corresponding":false},{"id":1137696,"name":"Stephanie Burns","orcid":null,"position":4,"is_corresponding":false},{"id":339141,"name":"Jason H. T. Bates","orcid":"0000-0002-6062-6377","position":5,"is_corresponding":false},{"id":335302,"name":"Ryan S. McGinnis","orcid":"0000-0001-8396-6967","position":6,"is_corresponding":false},{"id":304739,"name":"Vinciya Pandian","orcid":"0000-0002-2260-1080","position":7,"is_corresponding":false},{"id":1137697,"name":"Benjamin H Lin","orcid":null,"position":8,"is_corresponding":false},{"id":241333,"name":"Dale M. Needham","orcid":"0000-0002-9538-0557","position":9,"is_corresponding":false},{"id":306544,"name":"Renee D. Stapleton","orcid":null,"position":10,"is_corresponding":false},{"id":496099,"name":"Biren B. Kamdar","orcid":"0000-0002-9245-6229","position":0,"is_corresponding":true}],"reference_count":25,"raw_metadata":null,"created_at":"2026-07-19T01:16:19.336238Z","pmid":"39323600","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}