Performance Study of the Thermodiag Solution for Body Temperature Measurement

NCT06703931 | Not Yet Recruiting

• 1 other identifier: 2023-A02014-41_NIFC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

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).

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

Outcome Measures

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).

  Every minute from the enrollment to the end of medical treatment (estimated time : 8 days)

Study Arms (1)

Temperature Monitor

EXPERIMENTAL

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.

Device: Measures performed on all subjects

Interventions

Measures performed on all subjects DEVICE

In intensive care Medics will use a reference medical device and Thermodiag®. Simultaneous and synchronised measurements will be taken every minute.

Temperature Monitor

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• F2D Medical: lead
• Clinact Multihealth: collaborator
• Digital Medical Hub: collaborator

Study Sites (4)

Centre Hospitalier De Fleyriat

Bourg-en-Bresse, 01440, France

Location

Centre Hospitalier Intercommunal - Nord-Ardennes

Charleville-Mézières, 08000, France

Location

Hôpital Privé de l'Ouest Parisien

Trappes, 78190, France

Location

Hôpital Nord Franche-Comté

Trévenans, 90400, France

Location

MeSH Terms

Conditions

Body Temperature Changes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Benjamin MENARD, PhD

CONTACT

+33658918607; b.menard@f2d-medical.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Sponsor
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, comparative, multi-centre interventional clinical investigation

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 25, 2024
• Study Start: November 26, 2024
• Primary Completion: January 30, 2025
• Study Completion: March 30, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)