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

NCT07197411 | Not Yet Recruiting

• 1 other identifier: 202509141301
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Device Replacement

Outcome Measures

Primary Outcomes (1)

• 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

  through study completion, an average of six months

Study Arms (1)

cohort of healthy adults

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

Interventions

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

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

cohort of healthy adults

Hemodynamic monitoring DEVICE

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

cohort of healthy adults

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Include healthy individuals aged 18 to 79

You may qualify if:

• Age between 18 and 79 years; No abnormalities found in physical examination; Signed informed consent form.

You may not qualify if:

• Previous or current cardiovascular or cerebrovascular diseases; Carotid intima-media thickness (IMT) ≥ 1.0 mm or plaque; Arrhythmia; ④ BMI \> 35 kg/m²; Pregnancy.

Sponsors & Collaborators

• Xuzhou Medical University Affiliated Suqian Hospital: lead

Study Sites (1)

Xuzhou Medical University Affiliated Suqian Hospital

Suqian, Jiangsu, 223800, China

Location

MeSH Terms

Interventions

Hemodynamic Monitoring

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Monitoring, Physiologic

Central Study Contacts

MPH

CONTACT

86-15051314834; zhshqin@outlook.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Xuzhou Medical University Affiliated Suqian Hospital

Study Record Dates

• First Submitted: September 14, 2025
• First Posted: September 29, 2025
• Study Start: October 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)