NCT07197411

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 140 (estimated)
• Sponsor: Xuzhou Medical University Affiliated Suqian Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

Summary

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

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

• Device Replacement

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.
DEVICE	Hemodynamic monitoring	Whether the parameters monitored by portable patch-based ultrasound devices agree with the gold standard has not yet been thoroughly validated

Timeline

• Start date: 2025-10-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2025-09-29
• Last updated: 2025-09-29

Locations

1 site across 1 country: China