Performance Study of the Thermodiag Solution for Body Temperature Measurement

Официальное название

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

Обзор

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).

Вмешательства

• Устройство 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.

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 4 центра

• 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

Идентификаторы

NCT: NCT06703931 · 2023-A02014-41_NIFC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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