Novel Arm Restraint in the Intensive Care Unit

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study of a Novel Arm Restraint For Critically Ill Patients

Conditions
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Acute Respiratory Failure

Intervention / Treatment
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* Device: Novel restraint


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Novel restraint first, then traditional restraint<br>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<br>* Use of a novel arm restraint<br>|
| Experimental: Traditional restraint first, then novel restraint<br>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<br>* Use of a novel arm restraint<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Severe Adverse Events [Safety] | Safety will be measured by <20% mean incidence across all of the following measures listed below (each listed as individual measure) | Through study day 2 | 
| Incidence of clinician or patient laceration | 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 | 
| Incidence of pressure ulcer 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 | 
| Incidence of self-removal of novel restraint | Self-removal of novel restraint | Through study day 2 | 
| Incidence of damage to hospital bed rendering it non-functional | Any damage to hospital bed from restraint device rendering it non-functional | Through study day 2 | 
| incidence of damage to ICU equipment | Any damage to ICU equipment (e.g. ventilator) rendering it non-functional | Through study day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of self-extubation | Will record instances where participants remove own endotracheal tube | Through study day 2 | 
| Enrolling adequate number of patients | Demonstrate that conducting a future RCT is feasible by consent/recruitment into this study of 8 patients over 7 months | Study day 1 | 
| Upper extremity mobility | Actigraphy counts as measured by Philliips actigraph, a device that records individual movements | Continuously through study day 2 | 
| Sedation/agitation score | Agitation measured by the Richmond agitation sedation score [RASS] every hour while wearing restraints. This score measures sedation and agitation from a scale of -5 (most sedated) to +4 (most agitated) | Every hour through study day 2 | 
| Delirium score | Delirium measured Confusion assessment method-ICU (CAM-ICU) delirium score every 4 hours. This score is binary (i.e., delirium yes/no) based on answers to 4 questions. | Every 8 hours through study day 2 | 
| Satisfaction with novel device | 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). | Study day 2 |