Novel Arm Restraint in the Intensive Care Unit

Completed · Phase 1

Conditions studied: Acute Respiratory Failure

In brief

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.

Key facts

Study ID

NCT03621475

Run by

University of Vermont

People needed

8

Starts

2018-10-01

Expected to finish

2019-04-15

Last updated by the study team

2025-05-29

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• >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)

You may not qualify if…

• 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

Where it is running

• University of Vermont College of Medicine — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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