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| ID | Type | Description | Link |
|---|---|---|---|
| 0-00026 |
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The purpose of this study is to compare the accuracy of the Sotera ViSi, an investigational device, to auscultation (measurement with a cuff) in determining systolic and diastolic blood pressure (BP) in adult subjects.
This study is a single-center blinded study that will enroll approximately 150 adult subjects. Trained auscultators will perform the standard auscultation BP measurements. They will be blinded to each other's measurements and from the ViSi measurements.
The study population will be randomized into two groups based on the side of the blood pressure measurement: the left arm group (LAG) and the right arm group (RAG).
The randomization ratio of the LAG and RAG will be 1:1. There will be forced stratification in order to ensure that the study subjects meet the required arm circumference and blood pressure distributions as specified in the SP10:2008 and ISO 81060-2:2009(E) standards.
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Inclusion Criteria:
Exclusion Criteria:
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Eligible subjects are adults of any ethnic background who consent to spot-check blood pressure measurements and in whom paired blood pressure measurements with the ViSi will be feasible during a single visit. Subjects need to be greater than 12 years of age on the date of measurement and need to meet all the other inclusion and exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Margaret Drehobl, M.D. | Scripps Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Clinic Rancho Bernardo | San Diego | California | 92128 | United States |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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