B40 Non-Invasive Blood Pressure Equivalency Study
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||B40 Non-Invasive Blood Pressure Equivalency Study|
- Difference Between the B40 Monitor and Reference Device DINAMAP PRO1000 on NIBP Measurements [ Time Frame: End of each blood pressure reading ] [ Designated as safety issue: No ]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.
|Study Start Date:||March 2012|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Experimental: Blood Pressure Reading
Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings
Device: Blood Pressure Readings on B40 Patient Monitor
Simultaneous blood pressure reading on the Investigational B40 patient monitor and DINAMAP PRO1000 patient monitor
Automated non-invasive blood pressure devices have a long history. These devices first made their appearance in the mid-1970's. Since that time, there have been many improvements in the performance of these devices. Specifically, when making changes to the algorithms that control these devices, the goals are: to improve accuracy and precision in the blood pressure (BP) estimates, to reduce the time needed to determine the BP estimates, to increase comfort for the patient, and to work through artifacts and arrhythmias that are often present in the clinical environment.
The purpose of this study is to demonstrate equivalency of the GE Healthcare B40 Patient Monitor noninvasive blood pressure (NIBP) parameter compared to the reference device.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01546285
|United States, Colorado|
|Louisville, Colorado, United States, 80027|