Summary

for people ages 50 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion
Biren Kamdar, MD

Description

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.

Details

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.

Keywords

Acute Respiratory Failure Encephalopathy ARDS Sepsis Critical Illness Respiratory Insufficiency Brain Diseases Cognitive Dysfunction Exersides Exersides restraints first Traditional restraints first

Eligibility

You can join if…

Open to people ages 50 years and up

  • ≥50 years old
  • Requiring ICU care
  • Requiring wrist restraints and has active physician order
  • Expected ICU stay ≥2 days after enrollment
  • Responsive to verbal stimuli

You CAN'T join 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 primary systemic neuromuscular disease inhibiting upper extremity movement (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
  • Pregnant
  • Attending physician declines patient enrollment

Locations

  • University of California San Diego not yet accepting patients
    San Diego California 92093 United States
  • Johns Hopkins University not yet accepting patients
    Baltimore Maryland 21218 United States

Lead Scientist

  • Biren Kamdar, MD
    Assistant Clinical Professor, Medicine. Authored (or co-authored) 29 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of Vermont
ID
NCT04067622
Study Type
Interventional
Last Updated