Novel Arm Restraint in the Intensive Care Unit

Phase 1

Completed

Conditions: Acute Respiratory Failure

Interventions: Device: Novel restraint

Registration Number: NCT03621475

Lead Sponsor: University of Vermont

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 8

Inclusion Criteria

>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)

Exclusion Criteria

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)
Neuromuscular blocker infusion (eligible once infusion discontinued if other inclusion criteria met)
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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Traditional restraint first, then novel restraint	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.
Novel restraint first, then traditional restraint	Novel 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.

Primary Outcome Measures

Name	Time	Method
Number of Treatment-Emergent Severe Adverse Events [Safety]	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.
Number of Clinician or Patient Lacerations	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.
Number of Pressure Ulcers From Device	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)
Number of Self-removals of Novel Restraint	Through study day 2	Self-removal of novel restraint
Number of Damaging Events to Hospital Bed Rendering it Non-functional	Through study day 2	Any damage to hospital bed from restraint device rendering it non-functional
Number of Damaging Events to ICU Equipment	Through study day 2	Any damage to ICU equipment (e.g. ventilator) rendering it non-functional

Secondary Outcome Measures

Name	Time	Method
Number of Movements of Upper Extremities	Continuously through study day 2	Actigraphy counts of upper extremities as measured by Philliips actigraph, a device that records individual movements
Number of Self-extubations	Through study day 2	Will record instances where participants remove own endotracheal tube
Richmond Agitation Sedation Score [RASS]	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)
Satisfaction With Novel Device as Assessed by the Quebec User Evaluation of Satisfaction With Assistive Technology (QUEST) Satisfaction Score	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).
Delerium Score	6-day study period	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.

Trial Locations

Locations (1): University of Vermont College of Medicine
🇺🇸
Burlington, Vermont, United States
University of Vermont College of Medicine
🇺🇸Burlington, Vermont, United States