Reducing Physical Restraint in the ICU: Multicenter Phase II Randomized Trial of a Novel Device Versus Traditional Wrist Restraints

Abstract

Objectives: 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.

Design: Within-patient crossover phase II randomized trial.

Setting: Four U.S. academic medical centers.

Patients: ICU patients ( n = 54) who were verbally responsive with a provider order for wrist restraints and expected stay greater than or equal to 2 days.

Interventions: 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.

Measurements and main results: 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 2930-4395 vs. 3898-4910, respectively, with relative mean total activity count per session of 0.93 (95% CI, 0.76-1.13; p = 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 = 25) and clinicians ( n = 79), 58% and 51%, respectively, indicated high satisfaction with qualitative analyses demonstrating four positive and six constructive themes.

Conclusions: 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.

Keywords: actigraphy; critical illness; delirium; intensive care units; physical; restraint.