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NCT Number: NCT07197411

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

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.

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Key information

Conditions

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xuzhou Medical University Affiliated Suqian Hospital

Suqian, Jiangsu, 223800, China

Location contact

Ming Sun, Doctor

CONTACT

[email protected]

86-15951299800

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Evaluating the Consistency and Accuracy of Two Devices in Monitoring Hemodynamic Parameters

Diagnostic Test

This portable patch-type carotid ultrasound has not yet been used in clinical settings.

Hemodynamic Monitoring

Device

Whether the parameters monitored by portable patch-based ultrasound devices agree with the gold standard has not yet been thoroughly validated

Primary outcomes

  1. Evaluation of Consistency Between Two Devices

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Xuzhou Medical University Affiliated Suqian Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 29, 2025
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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