Marcelli Emanuela, Cercenelli Laura, Bortolani Barbara, Marini Saverio, Arfilli Luca, Capucci Alessandro, Plicchi Gianni
eDIMES Lab-Laboratory of Bioengineering, Department of Experimental, Diagnostic and Specialty Medicine (DIMES), Alma Mater Studiorum University of Bologna, Bologna, Italy.
Ars Medica: Associazione Medico-Chirurgica Della Gallura, Olbia, Italy.
Med Devices (Auckl). 2021 May 13;14:141-154. doi: 10.2147/MDER.S307775. eCollection 2021.
Venous congestion can be quantified by central venous pressure (CVP) and its monitoring is crucial to understand and follow the hemodynamic status of patients with cardio-respiratory diseases. The standard technique for CVP measurement is invasive, requiring the insertion of a catheter into a jugular vein, with potential complications. On the other hand, the current non-invasive methods, mainly based on ultrasounds, remain operator-dependent and are unsuitable for use in the home environment. In this paper, we will introduce a novel, non-invasive device for the hospital, office and home assessment of CVP.
After describing the measurement concept, we will report a preliminary experimental study enrolling 5 voluntary healthy subjects to evaluate the VenCoM measurements' repeatability, and the system's capability in measuring small elicited venous pressure variations (2 mmHg), as well as an induced venous hypertension within a pathological range (12÷20 mmHg).
The experimental measurements showed a repeatability of ±1mmHg. The VenCoM device was able to reliably detect the elicited venous pressure variations and the simulated congestive status.
The proposed non-invasive VenCoM device is able to provide a fast and repeatable CVP estimate, having a wide spectrum of potential clinical applications, including the monitoring of venous congestion in heart failure patients and in subjects with renal and hepatic dysfunction, as well as pulmonary hypertension (PH) that can be extended to pneumonia COVID-19 patients even after recovery. The device needs to be tested further on a large sample size of both healthy and pathological subjects, to systematically validate its reliability and impact in clinical setting.
静脉充血可通过中心静脉压(CVP)进行量化,其监测对于了解和跟踪心肺疾病患者的血流动力学状态至关重要。CVP测量的标准技术是侵入性的,需要将导管插入颈静脉,存在潜在并发症。另一方面,目前的非侵入性方法主要基于超声,仍然依赖操作者,且不适用于家庭环境。在本文中,我们将介绍一种用于医院、办公室和家庭评估CVP的新型非侵入性设备。
在描述测量概念后,我们将报告一项初步实验研究,该研究招募了5名自愿健康受试者,以评估VenCoM测量的可重复性,以及该系统测量小幅度诱发静脉压变化(2 mmHg)以及病理范围内诱发静脉高压(12÷20 mmHg)的能力。
实验测量显示可重复性为±1 mmHg。VenCoM设备能够可靠地检测诱发的静脉压变化和模拟的充血状态。
所提出的非侵入性VenCoM设备能够提供快速且可重复的CVP估计,具有广泛的潜在临床应用,包括监测心力衰竭患者、肾和肝功能不全患者以及肺动脉高压(PH)患者的静脉充血情况,甚至对于新冠肺炎康复患者也适用。该设备需要在大量健康和病理受试者样本上进一步测试,以系统地验证其在临床环境中的可靠性和影响。