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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Body temperature Measurement
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
Sponsor
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Temperature Monitor
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.
干预措施: Measures performed on all subjects (Device)
结局指标
主要结局
Body temperature Measurement
时间窗: Every minute from the enrollment to the end of medical treatment (estimated time : 8 days)
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).
次要结局
未报告次要终点
研究者
Daniel DA SILVA
Principal Investigator
Delafontaine Hospital