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ClinicalTrials.gov ID

NCT06703931

Lead Sponsor

F2D MedicalINDUSTRY

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

60Estimated

Last Update Posted

Nov 25, 2024Actual

Start Date

Nov 26, 2024Estimated

Primary Completion Date

Jan 30, 2025Estimated

Completion Date

Mar 30, 2025Estimated

Official Title

Evaluation of PERThermodiag® Medical Device for CT Temperature Measurement and Anomaly Detection Compared to Reference Methods in Critical Care Hospitalized Patients: a Comparative, Multi-center Interventional Study

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).

• Temperature Change, Body
• Emergency Department Visit

• Measures performed on all subjects

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Primary Purpose

Other

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

F2D MedicalINDUSTRY

Collaborators

Clinact MultihealthUNKNOWN

Digital Medical HubOTHER

pascal.mathis@hfnc.fr+33675629068