Novel Arm Restraint For Critically Ill Patients To Reduce Immobility, Sedation, Agitation and Cognitive Impairment

NCT04067622 | Completed DMC

• 1 other identifier: CHRMS-18-0353
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 3

Brief Summary

This study evaluates a novel arm restraint compared with traditional soft wrist restraints in older critically ill patients. The primary outcome is upper extremity mobility measured by actigraphy, and secondary outcomes include sedation, agitation, satisfaction, and acceptability.

Conditions

Acute Respiratory Failure; Encephalopathy; ARDS; Sepsis; Critical Illness

Outcome Measures

Primary Outcomes (1)

• Mobility assessed by actigraphy

  Upper extremity mobility will be evaluated by actigraphy. The Philips Respironics Spectrum Plus® actigraph is a commercially-available actigraphy device weighing 16 grams. It contains a battery-powered activity monitor and uses a highly sensitive accelerometer to monitor the occurrence and degree of motion. Only patients who wear both the novel restraint and traditional soft wrist restraints for at least 4 hours each will be included in the primary analysis.

  Up to 6 days

Secondary Outcomes (5)

• Sedation/Agitation

  Baseline, every 60 minutes on study days 1-2, every 4 hours on study days 3-6

• Delirium

  Baseline, every 4 hours days 1-2, twice daily days 3-6

• Average cumulative dose of sedative medications

  Up to 6 days

• Average cumulative dose of analgesic medications

  Up to 6 days

• Average cumulative dose of antipsychotic medications

  Up to 6 days

Other Outcomes (2)

• Satisfaction with novel restraint (nurses, family, physicians, and patients when able)

  Up to 6 days

• Acceptability of novel restraint (nurses, family, physicians, and patients when able)

  Up to 6 days

Study Arms (2)

Exersides restraints first

OTHER

Patients in this arm will wear the novel Exersides restraint during hours 1-4 on Day 1, then switched to soft wrist restrains during hours 5-8. On Day 2, patients in this arm will will wear soft wrist restraints during hours 1-4, and Exersides during hours 5-8. They will then wear Exersides during study days 3-6.

Device: Exersides

Traditional restraints first

OTHER

Patients in this arm will wear soft wrist restraints during hours 1-4 on Day 1; they will then be switched to the novel Exersides restraint during hours 5-8. On Day 2, patients in this arm will will wear Exersides during hours 1-4, and soft wrist restraints during hours 5-8. They will then wear soft wrist restraints during study days 3-6.

Device: Exersides

Interventions

Exersides DEVICE

A novel arm restraint which permits arm mobility but prohibits hands from reaching oral/nasal endotracheal and feeding tubes or intravenous lines.

Exersides restraints first; Traditional restraints first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years old
• Requiring ICU care
• Requiring wrist or mitt restraints and has active physician order
• Expected ICU stay ≥2 days after enrollment
• Responsive to verbal stimulus

You may not qualify if:

• Bilateral upper extremity impairments (e.g. arm injuries) or problems (e.g. severe skin breakdown) that prevent use of novel restraint device. Normal use of one arm (e.g. unilateral upper extremity amputation) is acceptable.
• Very limited mobility of bilateral upper extremities prior to admission (e.g. bilateral frozen shoulders). Normal use of one arm is acceptable.
• Pre-existing severe neuromuscular condition inhibiting or axacerbating upper extremity movement (e.g. Guillain-Barre, severe tremor, myoclonus)
• 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
• Pregnant
• Attending physician declines patient enrollment
• LAR unavailable to consent (and patient is unable to consent)
• Patient or LAR decline consent

Sponsors & Collaborators

• University of Vermont: lead
• Johns Hopkins University: collaborator
• University of California, San Diego: collaborator
• Healthy Design, LLC: collaborator

Study Sites (3)

University of California San Diego

San Diego, California, 92093, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

University of Vermont

Burlington, Vermont, 05405, United States

Location

MeSH Terms

Conditions

Brain Diseases; Sepsis; Critical Illness

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Renee Stapleton, MD, PhD

  University of Vermont

  PRINCIPAL INVESTIGATOR

• Dale Needham, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: Within-patient, randomized crossover design.

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: August 26, 2019
• Study Start: September 1, 2019
• Primary Completion: December 24, 2021
• Study Completion: December 28, 2021
• Last Updated: March 10, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)