Novel Arm Restraint in the Intensive Care Unit

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.

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