Performance Study of the Thermodiag Solution for Body Temperature Measurement (ThermodiagPERF)

F2D Medical

Status: Not yet enrolling

Conditions: Temperature Change, Body; Emergency Department Visit

Treatments: Device: Measures performed on all subjects

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06703931

2023-A02014-41_NIFC

Details and patient eligibility

About

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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Temperature Monitor

Experimental group

Description:

Patients included in the study will have their temperature measured simultaneously during their stay in intensive care, with Thermodiag(R) and with the reference medical device.

Treatment:

Device: Measures performed on all subjects