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Accuracy of Moni-Patch Compared With Tympanic Temperature Monitoring in Adults at Risk of Fever
Sponsor: Murata Vios, Inc.
Summary
This single-center, prospective clinical accuracy study evaluates the agreement between the Moni-Patch Temperature Monitoring Patch System and continuous tympanic temperature monitoring in adults at increased risk of developing fever during ICU care. Moni-Patch and an FDA-cleared continuous tympanic temperature sensor will be used concurrently for up to 24 hours. Agreement between the two temperature measurements will be evaluated using Bland-Altman analysis during a predefined febrile measurement window.
Official title: Moni-Patch Temperature Monitoring Patch System Clinical Accuracy Validation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
35
Start Date
2027-01-01
Completion Date
2028-01-01
Last Updated
2026-10-28
Healthy Volunteers
No
Conditions
Interventions
Moni-Patch Temperature Monitoring Patch System
A non-invasive wearable temperature monitoring sensor applied to the neck over the carotid region. Temperature will be monitored continuously for up to 24 hours.
Continuous Tympanic Temperature Monitoring System
An FDA-cleared continuous tympanic temperature monitoring system used as the clinical reference temperature measurement. The sensor will be placed in the ear and used concurrently with Moni-Patch for up to 24 hours.
Locations (1)
University of Minnesota Medical Center
Minneapolis, Minnesota, United States