Performance Study of the Thermodiag Solution for Body Temperature Measurement
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorF2D Medical
About this trial
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
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Measures performed on all subjects
DeviceIn intensive care Medics will use a reference medical device and Thermodiag®. Simultaneous and synchronised measurements will be taken every minute.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Temperature MonitorExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Body temperature Measurement
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).
Time frame
Every minute from the enrollment to the end of medical treatment (estimated time : 8 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
F2D Medical
Lead sponsor
Delafontaine Hospital
Sponsor institution
Clinact Multihealth
Collaborator
Digital Medical Hub
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: