Clinical Feasibility of a Conformal Ultrasound Blood Pressure Sensor

Medical Device Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05909605
• Other study ID #: 804119, 191474, 191527, 210799
• Status: Completed
• Start date: October 20, 2020
• Est. completion date: December 2, 2023

Study information

• Verified date: December 2023
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Feasibility Study
• Medical Device

Intervention

Device:
• sphygmomanometer
Comparison to the ultrasound sensor
• Arterial Line
Comparison to the ultrasound sensor

Locations

Country	Name	City	State
United States	UCSD	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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