Status:
COMPLETED
Novel Arm Restraint For Critically Ill Patients To Reduce Immobility, Sedation, Agitation and Cognitive Impairment
Lead Sponsor:
University of Vermont
Collaborating Sponsors:
Johns Hopkins University
University of California, San Diego
Conditions:
Acute Respiratory Failure
Encephalopathy
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Detailed Description
The goal of this Fast-Track STTR project is to optimize and test a novel arm restraint in older critically ill patients that increases mobility; reduces agitation, use of sedative medications, and del...
Eligibility Criteria
Inclusion
- ≥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
Exclusion
- 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)
- 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
- Pregnant
- Attending physician declines patient enrollment
- LAR unavailable to consent (and patient is unable to consent)
- Patient or LAR decline consent
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2021
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT04067622
Start Date
September 1 2019
End Date
December 28 2021
Last Update
March 10 2022
Active Locations (3)
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1
University of California San Diego
San Diego, California, United States, 92093
2
Johns Hopkins University
Baltimore, Maryland, United States, 21218
3
University of Vermont
Burlington, Vermont, United States, 05405