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Clinical Feasibility of a Conformal Ultrasound Blood Pressure Sensor

NCT ID: NCT05909605

Last Updated: 2023-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-20

Study Completion Date

2023-12-02

Brief Summary

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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

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Conditions

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Feasibility Study Medical Device

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ultrasound blood pressure sensor

sphygmomanometer

Intervention Type DEVICE

Comparison to the ultrasound sensor

Arterial Line

Intervention Type DEVICE

Comparison to the ultrasound sensor

Interventions

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sphygmomanometer

Comparison to the ultrasound sensor

Intervention Type DEVICE

Arterial Line

Comparison to the ultrasound sensor

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Sheng Xu

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UCSD

La Jolla, California, United States

Site Status

Countries

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United States

Other Identifiers

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804119, 191474, 191527, 210799

Identifier Type: -

Identifier Source: org_study_id