Novel Arm Restraint in the Intensive Care Unit

University of Vermont8 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Acute Respiratory Failure

Interventions

Novel restraintDEVICE

Use of a novel arm restraint

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. \>65 years old 2. Physician order for use of bilateral wrist restraints 3. Requiring mechanical ventilation with actual or expected total duration of \>48 hours 4. Expected ICU stay \>3 days after enrollment (to permit adequate exposure to proposed intervention) 5. Not deeply sedated (Richmond Agitation Sedation Scale \[RASS\] score \> -2) Exclusion Criteria: 1. Upper extremity impairments that prevent use of novel restraint device (e.g. amputation, arm injury) 2. Limited mobility of either upper extremity prior to admission (e.g. frozen shoulder, severe arthritis) 3. Pre-existing primary systemic neuromuscular disease (e.g. Guillain-Barre) 4. Neuromuscular blocker infusion (eligible once infusion discontinued if other inclusion criteria met) 5. Pre-existing severe cognitive impairment or language barrier prohibiting outcome assessment 6. Expected death or withdrawal of life-sustaining treatments within 6 days from enrollment 7. Incarcerated 8. Severe skin breakdown on either upper extremity

Locations (1)

University of Vermont College of Medicine

Burlington, Vermont, United States

Outcomes

Primary Outcomes

Number of Treatment-Emergent Severe Adverse Events [Safety]

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.