An observational study in Device Replacement, sponsored by Xuzhou Medical University Affiliated Suqian Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-29.
Sponsored by Xuzhou Medical University Affiliated Suqian Hospital · Observational
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.
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.
This is the only study on the registry with Xuzhou Medical University Affiliated Suqian Hospital as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Include healthy individuals aged 18 to 79
Exclusion Criteria:
Monitoring hemodynamic parameters in healthy subjects using two distinct devices
Diagnostic Test: Evaluating the Consistency and Accuracy of Two Devices in Monitoring Hemodynamic Parameters · Device: Hemodynamic monitoring
This portable patch-type carotid ultrasound has not yet been used in clinical settings.
Whether the parameters monitored by portable patch-based ultrasound devices agree with the gold standard has not yet been thoroughly validated
Evaluation of Consistency Between Two Devices
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
Time frame: through study completion, an average of six months
Plan to share: No
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This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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