Clinical Feasibility of a Conformal Ultrasound Blood Pressure Sensor

NCT05909605 | Completed

• 1 other identifier: 804119, 191474, 191527, 210799
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Feasibility Study; Medical Device

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Ultrasound blood pressure sensor

Device: sphygmomanometer; Device: Arterial Line

Interventions

sphygmomanometer DEVICE

Comparison to the ultrasound sensor

Ultrasound blood pressure sensor

Arterial Line DEVICE

Comparison to the ultrasound sensor

Ultrasound blood pressure sensor

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants without any severe cardiac anomalies

You may qualify if:

• Are able to provide informed consent
• Have at least one arm

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD

La Jolla, California, 92093, United States

Location

MeSH Terms

Interventions

Sphygmomanometers; Vascular Access Devices

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Catheters

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 18, 2023
• Study Start: October 20, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 2, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)