Clinical Feasibility of a Conformal Ultrasound Blood Pressure Sensor

University of California San Diego

Status: Completed

Conditions: Feasibility Study; Medical Device

Treatments: Device: sphygmomanometer; Device: Arterial Line

Study type: Observational

Funder types: Other

Identifiers

NCT05909605

804119, 191474, 191527, 210799

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

150 participants in 1 patient group

Ultrasound blood pressure sensor

Treatment:

Device: sphygmomanometer

Device: Arterial Line