Menu
Not yet recruiting NCT06703931

Performance Study of the Thermodiag Solution for Body Temperature Measurement

No phase Interventional Temperature Change, Body Emergency Department Visit

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Measures performed on all subjects.
Who it may be relevant to
Registry conditions: Temperature Change, Body, Emergency Department Visit. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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).

Interventions

  • Device Measures performed on all subjects
    In intensive care Medics will use a reference medical device and Thermodiag®. Simultaneous and synchronised measurements will be taken every minute.

Primary outcome measures

  • Body temperature Measurement [Time frame: Every minute from the enrollment to the end of medical treatment (estimated time : 8 days)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 4 centers
  • Centre Hospitalier De Fleyriat — Bourg-en-Bresse
  • Centre Hospitalier Intercommunal - Nord-Ardennes — Charleville-Mézières
  • Hôpital Privé de l'Ouest Parisien — Trappes
  • Hôpital Nord Franche-Comté — Trévenans

Identifiers

NCT: NCT06703931 · 2023-A02014-41_NIFC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗