Phase I Pilot Safety and Feasibility of a Novel Restraint Device for Critically Ill Patients Requiring Mechanical Ventilation

Overview

Journal J Intensive Care Soc

Publisher Sage Publications

Specialty Critical Care

Date 2024 Sep 26

PMID 39323600

Authors

Biren B Kamdar

Janelle M Fine

Marie T Pavini

Sara S Ardren

Stephanie Burns

Jason Ht Bates

Ryan S McGinnis

Vinciya Pandian

Benjamin H Lin

Dale M Needham

Renee D Stapleton

Affiliations

Soon will be listed here.

Abstract

Background: Mechanically ventilated Intensive Care Unit (ICU) patients often require wrist restraints, contributing to immobility and agitation, over-sedation, and delirium. The ® ® (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 ® 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 ® 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 ® 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 ®, 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 ® versus traditional wrist restraints. Feedback motivated minor device modifications before RCT initiation.

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