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OpenTrials
Completed

NCT Number: NCT05909605

Clinical Feasibility of a Conformal Ultrasound Blood Pressure Sensor

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.

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Key information

Conditions

Feasibility Study Medical Device

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UCSD

La Jolla, California, 92093, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sphygmomanometer

Device

Comparison to the ultrasound sensor

Arterial line

Device

Comparison to the ultrasound sensor

Primary outcomes

  1. 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. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 18, 2023
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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