Performance Study of the Thermodiag Solution for Body Temperature Measurement
Condition(s) studied
Investigational drug(s) / intervention(s)
Measures performed on all subjects: In intensive care Medics will use a reference medical device and Thermodiag®. Simultaneous and synchronised measurements will be taken every minute.
Study summary
The goal of this prospective, comparative, multi-centre interventional clinical investigation, is to evaluate the performance of the Thermodiag® medical device, compared with reference methods, for continuous measurement of core temperature in critical care patients. The main question it aims to answer is to develop non-invasive alternatives to the current methods of measuring core body, to reduce health risks, and overcome various other limitations (as infection, bleeding, thrombosis and local reactions).
Eligibility
Primary outcome measure(s)
- Body temperature Measurement — Every minute from the enrollment to the end of medical treatment (estimated time : 8 days)
The degree of agreement between the two medical devices (Thermodiag® versus reference method in the hospital unit) will be assessed (expected measure is less than 0.1°C).
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| Centre Hospitalier De Fleyriat | Bourg-en-Bresse | France | |
| Centre Hospitalier Intercommunal - Nord-Ardennes | Charleville-Mézières | France | |
| Hôpital Privé de l'Ouest Parisien | Trappes | France | |
| Hôpital Nord Franche-Comté | Trévenans | France |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06703931 on ClinicalTrials.gov ↗ ← All trials in France