Moni-Patch for Fever

AS
Overseen ByAsh Shibata
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Murata Vios, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults in the ICU who are at higher risk of developing a fever. Participants must be able to wear temperature monitoring devices and stay under observation for up to 24 hours.

Inclusion Criteria

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
I am 18 years old or older.
See 1 more

Exclusion Criteria

I do not have ear problems that prevent using a temperature probe in my ear.
Inability to properly seal the tympanic membrane temperature sensor with film dressing
My eardrum cannot be seen clearly with a microscope.
See 3 more

What Are the Treatments Tested in This Trial?

Trial Overview

The study compares how accurately the Moni-Patch Temperature Monitoring Patch measures body temperature versus a standard ear (tympanic) thermometer, with both used at the same time on each patient.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Moni-Patch and Tympanic Temperature MonitoringExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Murata Vios, Inc.

Lead Sponsor

University of Minnesota

Collaborator

Trials
1,459
Recruited
1,623,000+