Device Replacement
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTEvaluating 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.
DEVICEHemodynamic monitoring
Whether the parameters monitored by portable patch-based ultrasound devices agree with the gold standard has not yet been thoroughly validated
Sponsors
Xuzhou Medical University Affiliated Suqian Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Consistency Between Two Devices | 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 |
Countries
China
Contacts
Primary ContactMPH
Outcome results
None listed