Performance Study of the Thermodiag Solution for Body Temperature Measurement

Not Applicable

Not yet recruiting

• Conditions: Temperature Change, Body; Emergency Department Visit

• Registration Number: NCT06703931
• Lead Sponsor: F2D Medical

Brief 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-18
• Study First Submitted QC: 2024-11-21
• Last Update Submitted: 2024-11-21
• Study First Posted: 2024-11-25
• Last Update Posted: 2024-11-25
• Study Start: 2024-11-26
• Primary Completion: 2025-01-30
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients aged 18 to 80 years;
• Female or male patients;
• Patients hospitalised in a critical care unit as defined by the Public Health Code of the Republic of France, Article R6123-33: 'The critical care activity consists of the care of patients who present or are likely to present one or more acute failures directly threatening the vital or functional prognosis and which may require recourse to one or more methods of substitution'.
• Patients affiliated to the social security system or beneficiaries of such a system, where applicable, in accordance with local regulations;
• Voluntary patients - or trusted person/family member/relative who have given oral and written consent after being informed by the investigator of the research.

Exclusion Criteria

• Patients with a corpulence or physical characteristics responsible for a 'tourniquet' effect: arm circumference greater than 47 centimetres;
• Patients with burns on the arm (location for Thermodiag® measurement);
• Patients with particularly sensitive or affected skin in the biceps or armpit (left and right);
• Patients undergoing an MRI examination;
• Patients undergoing extracorporeal circulation;
• Patients with a history of allergy to silicone;
• Patients with active implantable medical devices such as pacemakers, defibrillators, etc. ;
• Patients undergoing dialysis;
• Patients with a tattoo in the area where the investigational device will be worn (arm);
• Patients currently excluded from another protocol or taking part in another interventional research study;
• Pregnant or breast-feeding women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (4)

Centre Hospitalier De Fleyriat; 🇫🇷 Bourg-en-Bresse, France

Centre Hospitalier Intercommunal - Nord-Ardennes; 🇫🇷 Charleville-Mezieres, France

Hôpital Privé de l'Ouest Parisien; 🇫🇷 Trappes, France

Hôpital Nord Franche-Comté; 🇫🇷 Trévenans, France