Novel Arm Restraint in the Intensive Care Unit

NCT03621475 | Completed Phase 1 Results

• 1 other identifier: 18-0353-01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Respiratory Failure

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• Number of Self-extubations

  Through study day 2

• Number of Movements of Upper Extremities

  Continuously through study day 2

• Richmond Agitation Sedation Score [RASS]

  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

  Study day 2

• Delerium Score

  6-day study period

Other Outcomes (1)

• Enrolling Adequate Numbers of Patients

  6-day study period

Study Arms (2)

Novel restraint first, then traditional restraint

EXPERIMENTAL

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

Traditional restraint first, then novel restraint

EXPERIMENTAL

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

Interventions

Novel restraint DEVICE

Use of a novel arm restraint

Novel restraint first, then traditional restraint; Traditional restraint first, then novel restraint

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Upper extremity impairments that prevent use of novel restraint device (e.g. amputation, arm injury)
• Limited mobility of either upper extremity prior to admission (e.g. frozen shoulder, severe arthritis)
• Pre-existing primary systemic neuromuscular disease (e.g. Guillain-Barre)
• Pre-existing severe cognitive impairment or language barrier prohibiting outcome assessment
• Expected death or withdrawal of life-sustaining treatments within 6 days from enrollment
• Incarcerated
• Severe skin breakdown on either upper extremity

Sponsors & Collaborators

• University of Vermont: lead
• Healthy Design, LLC: collaborator

Study Sites (1)

University of Vermont College of Medicine

Burlington, Vermont, 05405, United States

Location

Results Point of Contact

• Title: Renee Stapleton, MD, PhD
• Organization: University of Vermont

renee.stapleton@med.uvm.edu

(802) 656-7975

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: August 8, 2018
• Study Start: October 1, 2018
• Primary Completion: April 11, 2019
• Study Completion: April 15, 2019
• Last Updated: May 29, 2025
• Results First Posted: May 29, 2025

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)