Novel Arm Restraint in the Intensive Care Unit

NCT ID: NCT03621475

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2019-04-15

Brief Summary

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

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.

Conditions

Acute Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Novel restraint first, then traditional restraint

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.

Group Type: EXPERIMENTAL

Novel restraint

Intervention Type: DEVICE

Use of a novel arm restraint

Traditional restraint first, then novel restraint

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.

Group Type: EXPERIMENTAL

Novel restraint

Intervention Type: DEVICE

Use of a novel arm restraint

Interventions

Novel restraint

Use of a novel arm restraint

Intervention Type: DEVICE

Eligibility Criteria

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)

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

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)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Healthy Design, LLC

UNKNOWN

Sponsor Role: collaborator

University of Vermont

OTHER

Sponsor Role: lead

Responsible Party

Renee Stapleton

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Vermont College of Medicine

Burlington, Vermont, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

18-0353-01

Identifier Type: -

Identifier Source: org_study_id