Performance Study of the Thermodiag Solution for Body Temperature Measurement

Launched by F2D MEDICAL · Nov 21, 2024

Keywords

ClinConnect Summary

This clinical trial is looking into a new medical device called Thermodiag® that measures body temperature continuously without needing to insert anything into the body. This is important for patients in critical care, as current methods can sometimes cause infections or discomfort. The main goal is to find safer, non-invasive ways to monitor temperature, especially for patients who are very ill and might have serious health risks.

To participate in this trial, patients need to be between 18 and 80 years old and currently hospitalized in a critical care unit. They must also be able to give their consent or have a family member do so on their behalf. However, there are certain conditions that might prevent someone from joining, such as having very large arms, burns, sensitive skin, or certain medical devices like pacemakers. If eligible, participants can expect to have their core body temperature monitored using the Thermodiag® device, which is designed to be a safer alternative to traditional methods. The trial is currently not recruiting participants yet, so more information will become available soon.

Gender

ALL

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.