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临床试验/NCT07197411
NCT07197411尚未招募不适用

A Comparative Study of Portable Patch-type Carotid Ultrasound CADFlow and Desktop Ultrasound Machines

Xuzhou Medical University Affiliated Suqian Hospital1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
140
试验地点
1
主要终点
Evaluation of Consistency Between Two Devices

研究概览

简要总结

observational study The purpose of this observational study is to clarify the consistency, accuracy, and reproducibility of portable patch carotid ultrasound (CADFlow) compared to desktop ultrasound machines in detecting cardiac output (CO), peak velocity (Vmax), and minimum velocity (Vmin) in healthy volunteers.

详细描述

Parameters including cardiac output (CO), peak carotid artery velocity (Vmax), and minimum velocity (Vmin) were monitored in healthy subjects using a portable patch-type carotid ultrasound device (CADFlow). The subjects were placed in a supine position with the head rotated 30° to the contralateral side and the neck slightly extended. The dual-patch probe was then attached to the sites of the most prominent bilateral carotid artery pulsations. The automatic measurement mode was initiated to record blood flow waveforms for 60 seconds. After 30 minutes, the same subjects underwent reassessment of the aforementioned parameters using a conventional ultrasound system. The distal internal diameters of the bilateral common carotid arteries were measured in two-dimensional mode (mean of three measurements). Using pulsed-wave Doppler with an insonation angle ≤60°, Vmax and Vmin were recorded over three consecutive cardiac cycles. The probe was subsequently switched to a transthoracic cardiac probe for CO measurement at the left ventricular outflow tract (LVOT) (mean of three consecutive measurements). The order in which the subjects were monitored with the two devices was randomized.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 79 years; No abnormalities found in physical examination; Signed informed consent form.

排除标准

  • Previous or current cardiovascular or cerebrovascular diseases; Carotid intima-media thickness (IMT) ≥ 1.0 mm or plaque; Arrhythmia; ④ BMI > 35 kg/m²; Pregnancy.

结局指标

主要结局

Evaluation of Consistency Between Two Devices

时间窗: through study completion, an average of six months

Hemodynamic parameters, including cardiac output (CO), peak carotid artery velocity (Vmax), and minimum velocity (Vmin), were monitored in healthy subjects using both a portable patch-based ultrasound device and a conventional console ultrasound machine. The agreement and accuracy between the two devices were evaluated by comparing the correlation coefficients of the parameters and analyzing the mean bias using Bland-Altman plots

次要结局

未报告次要终点

研究者

发起方
Xuzhou Medical University Affiliated Suqian Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ming, Sun

Xuzhou Medical University Affiliated Suqian Hospital

Xuzhou Medical University Affiliated Suqian Hospital

研究点 (1)

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