Pilot Study of a Novel Arm Restraint For Critically Ill Patients
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- University of Vermont
- Enrollment
- 8
- Locations
- 2
- Primary Endpoint
- Number of Treatment-Emergent Severe Adverse Events [Safety]
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Number of Treatment-Emergent Severe Adverse Events [Safety]
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Through study day 2
Self-removal of novel restraint
Number of Damaging Events to Hospital Bed Rendering it Non-functional
Time Frame: Through study day 2
Any damage to hospital bed from restraint device rendering it non-functional
Number of Damaging Events to ICU Equipment
Time Frame: Through study day 2
Any damage to ICU equipment (e.g. ventilator) rendering it non-functional
Secondary Outcomes
- Number of Movements of Upper Extremities(Continuously through study day 2)
- Number of Self-extubations(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)
Investigators
Renee Stapleton
Associate Professor of Medicine
University of Vermont