Novel Arm Restraint in the Intensive Care Unit

Pilot Study of a Novel Arm Restraint For Critically Ill Patients

The goal of this pilot is to evaluate a novel restraint device in 8 older mechanically ventilated patients to demonstrate that 1) the revised novel restraint prototype is safe and 2) a future randomized controlled trial (RCT) is feasible.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Failure
• Intervention / Treatment: Device: Novel restraint

Detailed Description

The goal of this Fast-Track Small Business Technology Transfer (STTR) project is to optimize and test a novel arm restraint in older critically ill mechanically ventilated patients that may increase mobility; reduce agitation, use of sedative medications, and delirium; and exhibit high satisfaction and acceptability among hospital staff, family members, and patients. Older mechanically ventilated patients are often immobilized with wrist restraints to prevent self-extubation and are sedated to reduce agitation caused by their restraints and endotracheal (breathing) tube. This sedation and immobility lead to complications, including delirium and muscle weakness, that are independently associated with long term cognitive impairment, reduced physical functioning, and mortality. Specifically, the incidence and duration of delirium in the ICU are strongly and independently associated with long-term cognitive impairment that is similar to Alzheimer's Disease and Related Dementias.

Healthy Design has developed a novel restraint device that allows arm mobility but prohibits hands from reaching oral/nasal endotracheal and feeding tubes or intravenous lines. Because it permits mobility, the novel restraint may reduce agitation and the need for sedatives. The objectives of this pilot study are to evaluate the novel restraint in 8 older mechanically ventilated patients to demonstrate that 1) the revised novel restraint prototype is safe and 2) a future RCT is feasible.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Vermont
    • Burlington, Vermont, United States, 05405
      • University of Vermont College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. >65 years old
2. Physician order for use of bilateral wrist restraints
3. Requiring mechanical ventilation with actual or expected total duration of >48 hours
4. Expected ICU stay >3 days after enrollment (to permit adequate exposure to proposed intervention)
5. Not deeply sedated (Richmond Agitation Sedation Scale [RASS] score > -2)

Exclusion Criteria:

1. Upper extremity impairments that prevent use of novel restraint device (e.g. amputation, arm injury)
2. Limited mobility of either upper extremity prior to admission (e.g. frozen shoulder, severe arthritis)
3. Pre-existing primary systemic neuromuscular disease (e.g. Guillain-Barre)
4. Neuromuscular blocker infusion (eligible once infusion discontinued if other inclusion criteria met)
5. Pre-existing severe cognitive impairment or language barrier prohibiting outcome assessment
6. Expected death or withdrawal of life-sustaining treatments within 6 days from enrollment
7. Incarcerated
8. Severe skin breakdown on either upper extremity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Novel restraint first, then traditional restraint; Participants will be randomized to wear the novel arm restraint bilaterally for 4 hours on study day #1, followed by traditional soft bilateral wrist restraints for 4 hours. Then, on study day #2, they will wear both kinds of restraints in the opposite order.	Device: Novel restraint; Use of a novel arm restraint
Experimental: Traditional restraint first, then novel restraint; Participants will be randomized to wear traditional soft bilateral wrist restraints for 4 hours on study day #1, followed by the novel arm restraint bilaterally for 4 hours. Then, on study day #2, they will wear both kinds of restraints in the opposite order.	Device: Novel restraint; Use of a novel arm restraint

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Treatment-Emergent Severe Adverse Events [Safety]	Safety will be measured by the number (i.e. < 1 in 5 participants had a treatment emergent safety event per their on study time) across all of the following measures listed below. Incidence does not have to be per person-year; in this case it is incidence of safety adverse event during the study period.	Through study day 2
Number of Clinician or Patient Lacerations	Grade 2b or higher skin laceration (per Skin Tear Audit Research [STAR] Skin Tear Classification System) in patient or clinician from any sharp edges of device. The STAR grading system ranges from grade 1a at best to 3 at worst. Each laceration is given an individual score based on appearance.	Through study day 2
Number of Pressure Ulcers From Device	Development of pressure ulcer from device of Stage 3 or greater per 2016 National Pressure Ulcer Advisory Panel Pressure Injury Stages. This staging system provides an individual score to each pressure ulcer based on appearance from stage 1 (best) to stage 4 (worst)	Through study day 2
Number of Self-removals of Novel Restraint	Self-removal of novel restraint	Through study day 2
Number of Damaging Events to Hospital Bed Rendering it Non-functional	Any damage to hospital bed from restraint device rendering it non-functional	Through study day 2
Number of Damaging Events to ICU Equipment	Any damage to ICU equipment (e.g. ventilator) rendering it non-functional	Through study day 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Self-extubations	Will record instances where participants remove own endotracheal tube	Through study day 2
Number of Movements of Upper Extremities	Actigraphy counts of upper extremities as measured by Philliips actigraph, a device that records individual movements	Continuously through study day 2
Richmond Agitation Sedation Score [RASS]	Agitation measured by the median of Richmond agitation sedation score [RASS] collected longitudinally every hour while wearing restraints. This score measures sedation and agitation from a scale of -5 (most sedated) to +4 (most agitated)	Median of multiple RASS scores collected over first 2 days of study period
Satisfaction With Novel Device as Assessed by the Quebec User Evaluation of Satisfaction With Assistive Technology (QUEST) Satisfaction Score	Satisfaction with the novel restraint device will be measured with the Quebec User Evaluation of Satisfaction with assistive Technology (QUEST) satisfaction tool. This 12-item questionnaire is scored from 1 (lowest satisfaction) to 5 (highest satisfaction).	Study day 2
Delerium Score	We intended to measure delirium score as accessed by the CAM-ICU. However, during the study we were unable to measure it because it was too often incorrectly charted by nursing. We therefore have nothing to report for this planned outcome.	6-day study period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrolling Adequate Numbers of Patients	Number of participants enrolled in the study	6-day study period

Collaborators and Investigators

• Sponsor: University of Vermont
• Collaborators: Healthy Design, LLC

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): April 11, 2019
• Study Completion (Actual): April 15, 2019

Study Registration Dates

• First Submitted: July 23, 2018
• First Submitted That Met QC Criteria: August 2, 2018
• First Posted (Actual): August 8, 2018

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 9, 2025
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 18-0353-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No