Trial Outcomes & Findings for B40 Non-Invasive Blood Pressure Equivalency Study (NCT NCT01546285)
NCT ID: NCT01546285
Last Updated: 2013-06-21
Results Overview
The primary endpoints are the difference in systolic, diastolic and mean blood pressure values between the B40 Monitor and PRO1000. The mean of the difference should be no more than 5mmHg and the standard deviation of the difference should be no more than 8mmHg per the AAMI SP-10 standard.
COMPLETED
NA
66 participants
End of each blood pressure reading
2013-06-21
Participant Flow
Healthy subjects were recruited from 03.07.2012 - 03.23.2012 from Clinimark LLC, an independent physiology lab.
Subject distribution requirements (i.e. gender, blood pressure, and arm circumference)were reviewed as part of screening prior to subject enrollment.
Participant milestones
| Measure |
Blood Pressure Reading
Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings
|
|---|---|
|
Overall Study
STARTED
|
66
|
|
Overall Study
COMPLETED
|
66
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
B40 Non-Invasive Blood Pressure Equivalency Study
Baseline characteristics by cohort
| Measure |
Blood Pressure Reading
n=66 Participants
Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings
|
|---|---|
|
Age, Categorical
<=18 years
|
17 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=39 Participants
|
|
Age Continuous
|
32 years
STANDARD_DEVIATION 19.7 • n=39 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
66 participants
n=39 Participants
|
|
Systolic Blood Pressure
|
125.0 mmHg
STANDARD_DEVIATION 25.3 • n=39 Participants
|
|
Diastolic Blood Pressure
|
73 mmHg
STANDARD_DEVIATION 15.4 • n=39 Participants
|
|
Mean Arterial Pressure (MAP)
|
92.7 mmHg
STANDARD_DEVIATION 17.2 • n=39 Participants
|
PRIMARY outcome
Timeframe: End of each blood pressure readingPopulation: 66 subjects were enrolled. 64 subjects contributed data to the study. Subject 058 had a lateral difference of the reference diastolic blood pressure more than 10mmHg, and NIBP data was excluded from final analysis as specified in AAMI SP-10 standard. And Subject 046 had circulation issues and no data was collected.
The primary endpoints are the difference in systolic, diastolic and mean blood pressure values between the B40 Monitor and PRO1000. The mean of the difference should be no more than 5mmHg and the standard deviation of the difference should be no more than 8mmHg per the AAMI SP-10 standard.
Outcome measures
| Measure |
B40 and PRO1000 - Systolic BP
n=64 Participants
Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings
|
B40 and PRO1000 - Diastolic BP
n=64 Participants
|
B40 and PRO1000 - MAP
n=64 Participants
|
|---|---|---|---|
|
Difference Between the B40 Monitor and Reference Device DINAMAP PRO1000 on NIBP Measurements
|
-1.4 mmHg
Standard Deviation 4.8
|
-3.3 mmHg
Standard Deviation 2.6
|
-3.7 mmHg
Standard Deviation 4.2
|
Adverse Events
Blood Pressure Reading
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 The sponsor cannot require changes to the PI's disclosure, with the exception of requesting the removal of sponsor's confidential information. The study results themselves are not considered confidential information. Sponsor cannot extend the embargo beyond 60 days unless the PI's disclosure contains patentable subject matter, in which an embargo beyond 60 days may be necessary to allow for the filing of a patent application
- Publication restrictions are in place
Restriction type: OTHER