Murata Vios, Inc.
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.
Adult participants considered at increased risk of developing fever during ICU care may be enrolled before the onset of fever. Following ICU admission, the Moni-Patch sensor and an FDA-cleared continuous tympanic temperature reference sensor will be applied and monitored concurrently for up to 24 hours. The first 30 minutes after Moni-Patch application will be considered a stabilization period and excluded from the primary accuracy analysis. After stabilization, consecutive windows containing 30 simultaneous paired Moni-Patch and tympanic temperature observations will be evaluated. The earlie…
Inclusion Criteria: Age ≥18 years. Subject agrees to temperature sensor placement on the neck and ear. Subject is expected to receive ICU care and is considered by the clinical/research team to be at risk of developing fever during the monitoring period. The Moni-Patch sensor must be able to maintain an uninterrupted wireless connection with the Exclusion Criteria: Conditions of the ear that contraindicate placement of the tympanic temperature monitoring probe/sensor. Medical conditions such as inflammation, scratches, redness, or rash at the sensor placement sites. Use of barbiturates,…
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.
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.
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