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

Xuzhou Medical University Affiliated Suqian Hospital

Status

Not yet enrolling

Conditions

Device Replacement

Treatments

Device: Hemodynamic monitoring

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

Study type

Observational

Funder types

Other

Identifiers

NCT07197411

202509141301

Details and patient eligibility

About

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.

Full 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.

Enrollment

140 estimated patients

Sex

All

Ages

18 to 79 years old

Volunteers

Accepts Healthy Volunteers

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.