Clinical trial NCT06703931: Performance Study of the Thermodiag Solution for Body Temperature Measurement
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Temperature Change, Body
Emergency Department Visit
Keywords: Temperature
Body temperature
Monitoring temperature
multisensors
Actimetry
Actigraphy
Heart rate
Continuous measurement
Contextualized measure
Dedicated machine learning model
Machine Learning
Lead sponsor: F2D Medical
Sponsor class: INDUSTRY
Collaborators: name: Clinact Multihealth
name: Digital Medical Hub
First posted: 2024-11-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, comparative, multi-centre interventional clinical investigation
Primary purpose: OTHER

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).


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 outcomes:
measure: Body temperature Measurement
timeFrame: Every minute from the enrollment to the end of medical treatment (estimated time : 8 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Bourg-en-Bresse
country: France
facility: Centre Hospitalier De Fleyriat
city: Charleville-Mezieres
country: France
facility: Centre Hospitalier Intercommunal - Nord-Ardennes
city: Trappes
country: France
facility: Hôpital Privé de l'Ouest Parisien
city: Trévenans
country: France
facility: Hôpital Nord Franche-Comté
Study officials:
References: