Trial Outcomes & Findings for Novel Arm Restraint in the Intensive Care Unit (NCT NCT03621475)

NCT ID: NCT03621475

Last Updated: 2025-05-29

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 8 participants
• Primary outcome timeframe: Through study day 2
• Results posted on: 2025-05-29

Participant Flow

In two academic ICUs within the same medical center, non-comatose, mechanically ventilated adults >25 years old who required restraints and had an expected ICU stay of at least 2 days were evaluated for eligibility. The recruitment period was 10/2/2018 -- 4/8/2019.

Participant milestones

Measure	Novel Restraint First, Then Traditional Restraint Participants were 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 wore both kinds of restraints in the opposite order. Novel restraint: Use of a novel arm restraint	Traditional Restraint First, Then Novel Restraint Participants were 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 wore both kinds of restraints in the opposite order. Novel restraint: Use of a novel arm restraint
Overall Study STARTED	4	4
Overall Study COMPLETED	4	3
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Novel Restraint First, Then Traditional Restraint Participants were 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 wore both kinds of restraints in the opposite order. Novel restraint: Use of a novel arm restraint	Traditional Restraint First, Then Novel Restraint Participants were 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 wore both kinds of restraints in the opposite order. Novel restraint: Use of a novel arm restraint
Overall Study No longer required restraints at initiation	0	1

Baseline Characteristics

Novel Arm Restraint in the Intensive Care Unit

Baseline characteristics by cohort

Measure	Novel Restraint First, Then Traditional Restraint n=4 Participants Crossover design in which participants were 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 wore both kinds of restraints in the opposite order. Novel restraint: Use of a novel arm restraint	Traditional Restraint First, Then Novel Restraint n=3 Participants Crossover design in which participants were randomized to wear the traditional arm restraint bilaterally for 4 hours on study day #1, followed by novel soft bilateral wrist restraints for 4 hours. Then, on study day #2, they wore both kinds of restraints in the opposite order. Novel restraint: Use of a novel arm restraint	Total n=7 Participants Total of all reporting groups
Age, Customized	65.5 years n=5 Participants	64 years n=7 Participants	65 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Novel Restraint n=7 Participants Crossover design of novel and traditional hospital restraints. 7 participants wore the novel restraint.	Traditional Restraint n=6 Participants Crossover design of novel and traditional hospital restraints. 6 participants wore the traditional restraint.
Number of Treatment-Emergent Severe Adverse Events [Safety]	0 number of safety events	0 number of safety events

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Novel Restraint n=7 Participants Crossover design of novel and traditional hospital restraints. 7 participants wore the novel restraint.	Traditional Restraint n=6 Participants Crossover design of novel and traditional hospital restraints. 6 participants wore the traditional restraint.
Number of Clinician or Patient Lacerations	0 number of clinician/patient lacerations	0 number of clinician/patient lacerations

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Novel Restraint n=7 Participants Crossover design of novel and traditional hospital restraints. 7 participants wore the novel restraint.	Traditional Restraint n=6 Participants Crossover design of novel and traditional hospital restraints. 6 participants wore the traditional restraint.
Number of Pressure Ulcers From Device	0 number of pressure ulcers	0 number of pressure ulcers

PRIMARY outcome

Timeframe: Through study day 2

Self-removal of novel restraint

Outcome measures

Measure	Novel Restraint n=7 Participants Crossover design of novel and traditional hospital restraints. 7 participants wore the novel restraint.	Traditional Restraint n=6 Participants Crossover design of novel and traditional hospital restraints. 6 participants wore the traditional restraint.
Number of Self-removals of Novel Restraint	0 number of restraint removals	0 number of restraint removals

PRIMARY outcome

Timeframe: Through study day 2

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

Outcome measures

Measure	Novel Restraint n=7 Participants Crossover design of novel and traditional hospital restraints. 7 participants wore the novel restraint.	Traditional Restraint n=6 Participants Crossover design of novel and traditional hospital restraints. 6 participants wore the traditional restraint.
Number of Damaging Events to Hospital Bed Rendering it Non-functional	0 number of damage events to bed incidents	0 number of damage events to bed incidents

PRIMARY outcome

Timeframe: Through study day 2

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

Outcome measures

Measure	Novel Restraint n=7 Participants Crossover design of novel and traditional hospital restraints. 7 participants wore the novel restraint.	Traditional Restraint n=6 Participants Crossover design of novel and traditional hospital restraints. 6 participants wore the traditional restraint.
Number of Damaging Events to ICU Equipment	0 number of damage events to ICU equipment	0 number of damage events to ICU equipment

SECONDARY outcome

Timeframe: Through study day 2

Will record instances where participants remove own endotracheal tube

Outcome measures

Measure	Novel Restraint n=7 Participants Crossover design of novel and traditional hospital restraints. 7 participants wore the novel restraint.	Traditional Restraint n=6 Participants Crossover design of novel and traditional hospital restraints. 6 participants wore the traditional restraint.
Number of Self-extubations	0 number of self-extubations	0 number of self-extubations

SECONDARY outcome

Timeframe: Continuously through study day 2

Population: Enrolled subjects who wore the restraint/restraint alternative devices

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

Outcome measures

Measure	Novel Restraint n=7 Participants Crossover design of novel and traditional hospital restraints. 7 participants wore the novel restraint.	Traditional Restraint n=6 Participants Crossover design of novel and traditional hospital restraints. 6 participants wore the traditional restraint.
Number of Movements of Upper Extremities	27,509 number of movement events	24,686 number of movement events

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Novel Restraint n=7 Participants Crossover design of novel and traditional hospital restraints. 7 participants wore the novel restraint.	Traditional Restraint n=6 Participants Crossover design of novel and traditional hospital restraints. 6 participants wore the traditional restraint.
Richmond Agitation Sedation Score [RASS]	-1.5 score on a scale Interval -2.0 to 0.0	-1 score on a scale Interval -2.0 to -0.5

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Novel Restraint n=10 Participants Crossover design of novel and traditional hospital restraints. 7 participants wore the novel restraint.	Traditional Restraint Crossover design of novel and traditional hospital restraints. 6 participants wore the traditional restraint.
Satisfaction With Novel Device as Assessed by the Quebec User Evaluation of Satisfaction With Assistive Technology (QUEST) Satisfaction Score	3.5 score on a scale Interval 2.5 to 4.25	—

SECONDARY outcome

Timeframe: 6-day study period

Population: 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.

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6-day study period

Population: participants enrolled in the study

Number of participants enrolled in the study

Outcome measures

Measure	Novel Restraint n=4 Participants Crossover design of novel and traditional hospital restraints. 7 participants wore the novel restraint.	Traditional Restraint n=4 Participants Crossover design of novel and traditional hospital restraints. 6 participants wore the traditional restraint.
Enrolling Adequate Numbers of Patients	4 Participants	4 Participants

Adverse Events

Novel Restraint

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Traditional Restraint

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Renee Stapleton, MD, PhD

University of Vermont

Phone: (802) 656-7975

Email: renee.stapleton@med.uvm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place