B40 Non-Invasive Blood Pressure Equivalency Study

Blood Pressure Clinical Trial

Official title:

B40 Non-Invasive Blood Pressure Equivalency Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01546285
• Other study ID #: 118.04-2011-GES-0002
• Status: Completed
• Phase: N/A
• First received: February 28, 2012
• Last updated: May 2, 2013
• Start date: March 2012
• Est. completion date: March 2012

Study information

• Verified date: May 2013
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Device:
• Blood Pressure Readings on B40 Patient Monitor
Simultaneous blood pressure reading on the Investigational B40 patient monitor and DINAMAP PRO1000 patient monitor

Locations

Country	Name	City	State
United States	Clinimark	Louisville	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference Between the B40 Monitor and Reference Device DINAMAP PRO1000 on NIBP Measurements	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.	End of each blood pressure reading	No