Clinical Feasibility of a Conformal Ultrasound Blood Pressure Sensor

Study Overview
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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.

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

Conditions
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Feasibility Study, Medical Device

Intervention / Treatment
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* Device: sphygmomanometer
* Device: Arterial Line


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ultrasound blood pressure sensor<br> | Device: sphygmomanometer<br>* Comparison to the ultrasound sensor<br>Device: Arterial Line<br>* Comparison to the ultrasound sensor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device comparison to standard monitoring (Sphygmomanometer) | 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) | 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) | 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) | 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 |