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

  • STATUS
    Recruiting
  • End date
    Nov 1, 2022
  • participants needed
    60
  • sponsor
    University of Vermont
Updated on 17 February 2021
cognitive impairment
critical illness

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.

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 delirium; and exhibits high satisfaction and acceptability among hospital staff, family members, and patients. Older critically ill patients are often immobilized with wrist restraints to prevent self-removal of tubes and lines 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 is developing the novel ExersidesTM restraint that allows arm mobility but prohibits hands from reaching oral/nasal endotracheal and feeding tubes or intravenous lines. Because it permits mobility, ExersidesTM may reduce agitation and the need for sedatives. In preliminary pilot testing, ExersidesTM has demonstrated very encouraging results. The objectives of this STTR Fast-Track project are to optimize ExersidesTM and evaluate it in a randomized controlled trial (RCT) in older critically ill patients at high risk for delirium and associated long-term cognitive impairment. The multidisciplinary investigator team has expertise in critical care, extensive experience in conducting ICU RCTs, and a history of successful collaboration.

Phase I of the STTR, during which the novel restraint device was modified based on feedback from healthy volunteers and a single-center prospective pilot study was performed in 8 older patients with acute respiratory failure, has already been completed. The Phase I pilot study has demonstrated that 1) the revised ExersidesTM prototype is safe and 2) the RCT proposed in Phase II is feasible.

Therefore, Phase II of the STTR will now occur. In Phase II, a multi-site within-patient crossover RCT in older critically ill patients requiring restraint will be conducted to test the following outcomes in ExersidesTM versus traditional wrist restraint: 1) Mobility assessed by actigraphy (primary outcome); 2) Agitation, delirium, and medication use (secondary outcomes); and 3) Satisfaction with and acceptability/perceptions of the device (secondary outcomes). Successful completion of this project will result in an ExersidesTM restraint that is ready for final optimization in preparation for commercialization, and is suitable for larger clinical studies to demonstrate effectiveness reducing long-term cognitive impairment in older ICU patients.

Details
Condition Septicemia, Sepsis and Septicemia, ADULT RESPIRATORY DISTRESS SYNDROME, Acute Respiratory Distress Syndrome (ARDS), Critical Illness, encephalopathy, Sepsis and Septicemia, Acute Respiratory Distress Syndrome (ARDS), Acute Respiratory Failure, critically ill, systemic infection, systemic infections, acute respiratory distress syndrome, ards, sepsis, sepsis syndrome
Treatment Exersides
Clinical Study IdentifierNCT04067622
SponsorUniversity of Vermont
Last Modified on17 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
Clear my responses

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