Clinical Feasibility of a Conformal Ultrasound Blood Pressure Sensor

Completed

• Conditions: Medical Device; Feasibility Study
• Interventions: Device: sphygmomanometer; Device: Arterial Line

• Registration Number: NCT05909605
• Lead Sponsor: University of California, San Diego

Brief Summary

Blood pressure (BP) monitoring is essential for managing cardiovascular diseases. Arterial line (A-line), the clinical gold standard for BP monitoring, is too invasive for routine measurements. The sphygmomanometer, on the other hand, is non-invasive but captures only discrete values. The recently introduced conformal ultrasound sensor offers non-invasive and continuous monitoring of BP, which can potentially improve the quality of patient care, but its accuracy has yet to be thoroughly validated. Here the investigators are working to validate the accuracy of a redesigned ultrasound sensor with enhanced reliability in BP measurements at-home and in clinics even under different interventions.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-20
• Study First Submitted: 2023-06-01
• Study First Submitted QC: 2023-06-11
• Study First Posted: 2023-06-18
• Status Verified: 2023-12
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-02
• Last Update Submitted: 2023-12-03
• Last Update Posted: 2023-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Are able to provide informed consent
• Have at least one arm

Exclusion Criteria

• Active cardiac arrhythmias
• Any other unstable, active medical condition (i.e., cardiac arrythmia, uncontrolled diabetes, active heart failure, active liver failure)
• Currently pregnant (this will be confirmed with a urine pregnancy test in women of childbearing potential)
• Any large movements of the arms (e.g., chorea, dyskinesias, ballism), that in the investigators' opinion, would make it difficult to measure blood pressure using a standard blood pressure cuff
• Any active skin infection or wound on the arm that would interfere with the devices used to measure blood pressure
• Diagnosis of dementia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ultrasound blood pressure sensor	Arterial Line	-
Ultrasound blood pressure sensor	sphygmomanometer	-

Primary Outcome Measures

Name	Time	Method
Device comparison to standard monitoring (Sphygmomanometer)	4 years	Clinical feasibility of the device accuracy of the non-invasive ultrasound blood pressure sensor in comparison to a sphygmomanometer on 90 participants in consulting room on orthostatic hypotension participants.
Device comparison to standard monitoring (A-line)	3 years	Clinical feasibility of the ultrasound blood pressure sensor in comparison to an arterial line in the catheterization laboratory on 40 participants.

Trial Locations

Locations (1)

UCSD; 🇺🇸 La Jolla, California, United States