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B40 Non-Invasive Blood Pressure Equivalency Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01546285
First received: February 28, 2012
Last updated: May 2, 2013
Last verified: May 2013

February 28, 2012
May 2, 2013
March 2012
March 2012   (final data collection date for primary outcome measure)
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.
Blood Pressure Reading [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Blood pressure readings to determine equivalency at study completion
Complete list of historical versions of study NCT01546285 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
B40 Non-Invasive Blood Pressure Equivalency Study
B40 Non-Invasive Blood Pressure Equivalency Study

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Blood Pressure
Device: Blood Pressure Readings on B40 Patient Monitor
Simultaneous blood pressure reading on the Investigational B40 patient monitor and DINAMAP PRO1000 patient monitor
Experimental: Blood Pressure Reading
Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings
Intervention: Device: Blood Pressure Readings on B40 Patient Monitor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
March 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ability to provide written informed consent or have a legally authorized representative including a parent or guardian provide written informed consent
  • Within the age range from older than 3 years old to 75 years old (adult and child)
  • Ability to maintain proper placement of cuff and/or probe and/or sensor

Exclusion Criteria:

  • Neonates (ages 0-29 days) and infants (30 days to 3 years old) shall be excluded
  • Any subject deemed too unstable, by clinician's discretion, or for another reason deemed unacceptable for study by the clinician
  • Known dysrhythmias (when applicable)
  • Known disease state that compromises circulation to the extremity
  • Vigorous exercise prior to participating in the study
  • Excessive movement or excitability causing false values or no determinations
  • Known allergy to latex when latex products will be in contact with subject
  • Pregnant females
Both
3 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01546285
118.04-2011-GES-0002
No
GE Healthcare
GE Healthcare
Not Provided
Not Provided
GE Healthcare
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP