NCT01546285

B40 Non-Invasive Blood Pressure Equivalency Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 3 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Blood Pressure

Interventions

Type	Name	Description
DEVICE	Blood Pressure Readings on B40 Patient Monitor	Simultaneous blood pressure reading on the Investigational B40 patient monitor and DINAMAP PRO1000 patient monitor

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2012-03-07
• Last updated: 2013-06-21
• Results posted: 2013-06-21

Locations

1 site across 1 country: United States