Accuracy of Moni-Patch Compared With Tympanic Temperature Monitoring in Adults at Risk of Fever

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.

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, thyroid preparations, antipsychotics, or recent immunizations. Inability to securely adhere the Moni-Patch sensor to the skin or accurately position it over the carotid artery. Inability to properly seal the tympanic membrane temperature sensor with film dressing. Tympanic membrane cannot be visually confirmed using a microscope.