Phase I pilot safety and feasibility of a novel restraint device for critically ill patients requiring mechanical ventilation

Background: Mechanically ventilated Intensive Care Unit (ICU) patients often require wrist restraints, contributing to immobility and agitation, over-sedation, and delirium. The Exersides & REG; Refraint & REG; (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 & REG; safety and feasibility in anticipation of a multi-site Phase II randomized controlled trial (RCT). Methods: In two academic ICUs, mechanically ventilated adults & GT;25 years old who were non-comatose, required restraints and had an expected stay of & GT;2 days were enrolled to wear Exersides & REG; 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 & REG; safety (i.e., patient/clinician lacerations/injuries), feasibility (i.e., & GT;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 & REG;, 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 & REG; versus traditional wrist restraints. Feedback motivated minor device modifications before RCT initiation.