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
  Purpose

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.


Condition Intervention
Blood Pressure
Device: Blood Pressure Readings on B40 Patient Monitor

Study Type: Interventional
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

Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • 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.


Enrollment: 66
Study Start Date: March 2012
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   3 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01546285

Locations
United States, Colorado
Clinimark
Louisville, Colorado, United States, 80027
Sponsors and Collaborators
GE Healthcare
  More Information

No publications provided

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01546285     History of Changes
Other Study ID Numbers: 118.04-2011-GES-0002
Study First Received: February 28, 2012
Results First Received: January 16, 2013
Last Updated: May 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by GE Healthcare:
The focus of this study is to demonstrate that DINAMAP® SuperSTATTM NIBP algorithm has been implemented correctly without performance losses to the B40 monitor

ClinicalTrials.gov processed this record on July 29, 2014