Clinical Feasibility of a Conformal Ultrasound Blood Pressure Sensor

December 3, 2023 updated by: Sheng Xu, University of California, San Diego

Non-invasive Measurements of Arterial Pulses and Blood Pressure Using a Novel Ultrasound Patch

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093
        • UCSD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants without any severe cardiac anomalies

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ultrasound blood pressure sensor
Device: sphygmomanometer
Comparison to the ultrasound sensor
Device: Arterial Line
Comparison to the ultrasound sensor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device comparison to standard monitoring (Sphygmomanometer)
Time Frame: 2 years
Clinical feasibility of the calibration accuracy of the non-invasive ultrasound blood pressure sensor in comparison to a sphygmomanometer on 10 participants.
2 years
Device comparison to standard monitoring (A-line)
Time Frame: 2 years
Clinical feasibility of the ultrasound blood pressure sensor for monitoring trend changes for continuous 12 hours of measurement in comparison to an arterial line in the Intensive Care Unit on 10 participants.
2 years
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.
3 years
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.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2020

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

December 2, 2023

Study Registration Dates

First Submitted

June 1, 2023

First Submitted That Met QC Criteria

June 11, 2023

First Posted (Actual)

June 18, 2023

Study Record Updates

Last Update Posted (Estimated)

December 5, 2023

Last Update Submitted That Met QC Criteria

December 3, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 804119, 191474, 191527, 210799

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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