NCT03621475

Novel Arm Restraint in the Intensive Care Unit

Completed Phase 1 Results posted Last updated 29 May 2025

What this trial tests

Phase 1 trial testing Novel restraint in Acute Respiratory Failure in 8 participants. Completed in 15 April 2019.

Timeline

1 October 2018

Primary endpoint
11 April 2019

15 April 2019

Quick facts

Lead sponsor	University of Vermont
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	prevention
Enrollment	8
Start date	1 October 2018
Primary completion	11 April 2019
Estimated completion	15 April 2019
Sites	1 location across United States

Drugs / interventions tested

• Novel restraint

Conditions studied

• Acute Respiratory Failure — all drugs for Acute Respiratory Failure →

Sponsor

University of Vermont

Who can join

65 and older, any sex, with Acute Respiratory Failure. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Treatment-Emergent Severe Adverse Events [Safety] Primary · Through study day 2

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.

Group	Value	95% CI
Novel Restraint	0
Traditional Restraint	0

Number of Clinician or Patient Lacerations Primary · Through study day 2

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.

Group	Value	95% CI
Novel Restraint	0
Traditional Restraint	0

Number of Pressure Ulcers From Device Primary · Through study day 2

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)

Group	Value	95% CI
Novel Restraint	0
Traditional Restraint	0

Number of Self-removals of Novel Restraint Primary · Through study day 2

Self-removal of novel restraint

Group	Value	95% CI
Novel Restraint	0
Traditional Restraint	0

Number of Damaging Events to Hospital Bed Rendering it Non-functional Primary · Through study day 2

Any damage to hospital bed from restraint device rendering it non-functional

Group	Value	95% CI
Novel Restraint	0
Traditional Restraint	0

Number of Damaging Events to ICU Equipment Primary · Through study day 2

Any damage to ICU equipment (e.g. ventilator) rendering it non-functional

Group	Value	95% CI
Novel Restraint	0
Traditional Restraint	0

Number of Self-extubations Secondary · Through study day 2

Will record instances where participants remove own endotracheal tube

Group	Value	95% CI
Novel Restraint	0
Traditional Restraint First, Then Novel Restraint	0

Number of Movements of Upper Extremities Secondary · Continuously through study day 2

Actigraphy counts of upper extremities as measured by Philliips actigraph, a device that records individual movements

Group	Value	95% CI
Novel Restraint	27,509
Traditional Restraint	24,686

Richmond Agitation Sedation Score [RASS] Secondary · Median of multiple RASS scores collected over first 2 days of study period

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)

Group	Value	95% CI
Novel Restraint	-1.5	-2 – 0
Traditional Restraint	-1	-2 – -0.5

Satisfaction With Novel Device as Assessed by the Quebec User Evaluation of Satisfaction With Assistive Technology (QUEST) Satisfaction Score Secondary · Study day 2

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).

Group	Value	95% CI
Patient Proxies, Physicians and Nurses	3.5	2.5 – 4.25

Enrolling Adequate Numbers of Patients Secondary · 6-day study period

Number of participants enrolled in the study

Group	Value	95% CI
Novel Restraint First, Then Traditional Restraint	4
Traditional Restraint First, Then Novel Restraint	4

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Actigraphy to Measure Physical Activity in the Intensive Care Unit: A Systematic Review.
   Schwab KE, To AQ, Chang J, Ronish B, et al · · 2020 · cited 27× · PMID 31331220 · DOI 10.1177/0885066619863654