The primary endpoints for this study are mean and standard deviation error measurements for the VLDBPM versus manual auscultation.
This is a prospective, controlled, single-arm clinical evaluation. Five hundred thirty-two (532) subjects are planned to be evaluated. Each subject's blood pressure will be measured using the VLDBPM and manual auscultation. Each subject will be observed while undergoing a series of blood pressure perturbation challenges. Means measurement differences from the test sensor and the reference auscultation measurements will be used to validate the accuracy of the VDBPM software system. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. Total duration of subject participation will be 1 to 1.5 hours. Total duration of the study is expected to be 6 months. Following medical history and patient eligibility assessments, eligible patients will be offered participation in the study. Once subjects are consented/enrolled, measurements will be performed in accordance with Data Collection Procedure section below.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
343
The Vital Labs Digital Blood Pressure monitor is a software-as-a-medical device (SaMD) that is capable of determining blood pressure, after calibration, using waveform changes observed in photoplethysmogram signals.
University of California San Francisco
San Francisco, California, United States
Diablo Clinical Research
Walnut Creek, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Mean difference between BP measures
Primary efficacy
Time frame: Baseline
Standard deviation of differences between BP measures
Primary Efficacy
Time frame: Baseline
Mean difference between BP measures
Primary efficacy
Time frame: 1.5 hours
Standard deviation of differences between BP measures
Primary Efficacy
Time frame: 1.5 hours
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