An observational study in Feasibility Study and Medical Device, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-05.
Sponsored by University of California, San Diego · Observational
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.
University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants without any severe cardiac anomalies
Exclusion Criteria:
Device: sphygmomanometer · Device: Arterial Line
Comparison to the ultrasound sensor
Comparison to the ultrasound sensor
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 4 years
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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University of California, San Diego