Non-invasive Measurements of Arterial Pulses and Blood Pressure Using a Novel Ultrasound Patch
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Device comparison to standard monitoring (Sphygmomanometer)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Device comparison to standard monitoring (Sphygmomanometer)
Time Frame: 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)
Time Frame: 3 years
Clinical feasibility of the ultrasound blood pressure sensor in comparison to an arterial line in the catheterization laboratory on 40 participants.
Secondary Outcomes
No secondary outcomes reported
Investigators
Sheng Xu
Associate Professor
University of California, San Diego