Trial Outcomes & Findings for VicorderCS NIBP Validation Study to Review The Ability to Capture Blood Pressure Measurements (NCT NCT06560034)
NCT ID: NCT06560034
Last Updated: 2026-06-29
Results Overview
A mean difference was measured between the VicorderCS noninvasive blood pressure measurement method and the auscultation method using a Korotkoff sounds device with human observers' readings.
COMPLETED
86 participants
1 Day
2026-06-29
Participant Flow
Recruitment will be performed using email and a flier. Text of the recruitment emails will contain the following information: * Brief description of the study. * Importance of the proposed research * The study will be conducted entirely at the aforementioned location and last for approximately 40 minutes
As described further in the following section on recruitment methods, participants will be sent an email providing information on the study and providing steps to enroll. Members who respond to recruitment emails will be directed to a link where they can schedule their study time and sign a consent form. They will have the opportunity to contact study personnel with questions if necessary. During "sign up", participants will be taken through a questionnaire to collect relevant information.
Participant milestones
| Measure |
Cross-Sectional
Blood pressure data were obtained from a total of 86 subjects
|
|---|---|
|
Overall Study
STARTED
|
86
|
|
Overall Study
COMPLETED
|
86
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cross-Sectional
n=86 Participants
Blood Pressure
|
|---|---|
|
Age, Continuous
|
40.2 Years
STANDARD_DEVIATION 16.23 • n=86 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=86 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=86 Participants
|
|
Region of Enrollment
United States
|
86 Participants
n=86 Participants
|
PRIMARY outcome
Timeframe: 1 DayA mean difference was measured between the VicorderCS noninvasive blood pressure measurement method and the auscultation method using a Korotkoff sounds device with human observers' readings.
Outcome measures
| Measure |
Cross-Sectional
n=86 Participants
Blood pressure data were obtained from a total of 86 subjects
|
|---|---|
|
Blood Pressure
Systolic Blood Pressure
|
-4.63 mmHg
Standard Deviation 5.32
|
|
Blood Pressure
Diastolic Blood Pressure
|
2.27 mmHg
Standard Deviation 4.93
|
Adverse Events
Cross-Sectional Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place