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

NCT ID: NCT07197411

Last Updated: 2025-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Device Replacement

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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cohort of healthy adults

Monitoring hemodynamic parameters in healthy subjects using two distinct devices

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

Intervention Type DIAGNOSTIC_TEST

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

Hemodynamic monitoring

Intervention Type DEVICE

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

Interventions

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

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

Intervention Type DIAGNOSTIC_TEST

Hemodynamic monitoring

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Xuzhou Medical University Affiliated Suqian Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ming, Sun

Xuzhou Medical University Affiliated Suqian Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Xuzhou Medical University Affiliated Suqian Hospital

Suqian, Jiangsu, China

Site Status

Countries

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China

Central Contacts

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MPH

Role: CONTACT

86-15051314834

Facility Contacts

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Ming Sun, Doctor

Role: primary

86-15951299800

Other Identifiers

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202509141301

Identifier Type: -

Identifier Source: org_study_id

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