Novel Arm Restraint in the Intensive Care Unit

University of Vermont

Status and phase: Completed; Phase 1

Conditions: Acute Respiratory Failure

Treatments: Device: Novel restraint

Study type: Interventional

Funder types: Other

Identifiers

NCT03621475

18-0353-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Novel restraint first, then traditional restraint

Experimental group

Description:

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.

Treatment:

Device: Novel restraint

Traditional restraint first, then novel restraint

Experimental group

Description:

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.

Treatment:

Device: Novel restraint