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临床试验/NCT05943275
NCT05943275招募中不适用

Validation of a Magnetic Sensor for the Non-invasive Measurement of Jugular Venous and Radial Arterial Pressure in Patients During Cardiac Catheterization

University Hospital, Montpellier2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年9月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10
试验地点
2
主要终点
Estimate the concordance between the mean peak atrial pressure values measured by the two methods (invasive and magnetic sensor) over a 15-minute period.

研究概览

简要总结

Follow-up of patients with complex congenital heart disease (CHD) usually involves ultrasound imaging or even MRI or CT scans of the heart and stress testing. But these examinations can be challenged in terms of their sensitivity. Thus, the development of non-invasive jugular venous and radial arterial pressure sensors, reflecting the hemodynamic function of the right heart, would be very useful to the clinician responsible for early detection of a deficit in right ventricular function.

详细描述

Among the 1% of live births with congenital heart disease, 20% have complex congenital heart disease (CHD). Their life expectancy, initially low, is constantly improving due to diagnostic, follow-up and therapeutic advances, particularly surgical. The pediatric population surviving the neonatal period is increasingly high and the number of people reaching adulthood has even exceeded the pediatric population for the last 3 years, a number that puts adult cardiologists in difficulty as they have little knowledge of the natural history of these pathologies. Indeed, it is difficult to predict or diagnose early decompensation or deterioration of cardiac function, especially for those affecting right heart function, because the anatomic and hemodynamic particularities of these CHDs make the usual functional exploration parameters not very sensitive. Indeed, the dysfunction of ventricular function is progressive and these patients remain asymptomatic for a long time and then decompensate suddenly. The late symptoms and the anatomic difficulty in adapting paraclinical criteria used for morphologically normal hearts explain their difficult interpretation and a delay in management. The current evaluation of these CHDscombining ultrasound imaging or even MRI or cardiac CT and stress testing is often flawed in terms of their sensitivity, because of the anatomic geometric complexity of these heart diseases.

Thus, the development of a non-invasive jugular venous pressure sensor, reflecting the hemodynamic function of the right heart, would be very useful to the clinician responsible for the follow-up of subjects with CHD, in order to detect early a deficit in right ventricular function.

F. Terki and H. Tran of the DynaCar team "Dynamics of cardiac couplings" of the Laboratory of Physiology Experimental Medicine (PhyMedExp), have developed an innovative medical detection device in partnership with the Laboratory of Coordination Chemistry LCC of the CNRS of Toulouse (A. Bousseksou) and the company eV-technologies (S. Wane and H. Tran), allowing to measure this jugular venous pressure by simple apposition of this one on the vein. A small magnet of 1cm X 1cm is placed beside the sensor. The very weak magnetic field of this magnet (0,02 Tesla) will generate a voltage at the terminals of the micro-sensor placed just beside. This voltage will reflect the pressure force related to the blood flow circulating in the cardiovascular network and give information on the heartbeat by magnetic measurements. The magnet and the micro-sensor are encapsulated in a plastic support of 3cm X1 cm and clipped on a flexible bracelet that can be affixed to the neck.

The magnetic field of the magnet used is of the order of magnitude of that of the fridge magnets (0.02 Tesla). It is therefore not harmful. It is 75 times weaker than that used in MRI (1.5T).

This device does not require the use of contrast agents, no patch and no adhesive product and is without direct contact with the skin.

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient who receives a right-sided catheterization
  • Age ≥ 18 years
  • Informed consent

排除标准

  • Patient with a metal implant near the area of use of the device
  • Pregnant or breastfeeding woman
  • Patient unwilling or unable to sign consent: patient under guardianship or conservatorship, mentally retarded, dementia, language barrier
  • Patient not affiliated to a social security system
  • Patient under court protection

结局指标

主要结局

Estimate the concordance between the mean peak atrial pressure values measured by the two methods (invasive and magnetic sensor) over a 15-minute period.

时间窗: Baseline

Average value of the atrial peak pressure measured by both methods (invasive and magnetic sensor) over a 15-minute period.

次要结局

  • Assess whether there is an overlap between the jugular venous pressure curve obtained with a magnetic sensor and the invasive central venous pressure curve(baseline)
  • Evaluate whether there is an overlap, during a simultaneous measurement, between the jugular venous pressure curve and the radial arterial pressure curve obtained with a magnetic and the radial arterial pressure curve obtained with a magnetic sensor(baseline)
  • Assess whether there is an overlap between the jugular venous pressure curve obtained with a magnetic sensor and the invasive central venous pressure curve (atrial filling)(baseline)
  • Assess whether there is an overlap between the jugular venous pressure curve obtained with a magnetic sensor and the invasive central venous pressure curve (Area under the pressure curve during a cardiac revolution)(baseline)
  • To evaluate the safety of measuring jugular venous pressure or radial arterial pressure with a magnetic sensor in patients.(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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