B40 Non-Invasive Blood Pressure Equivalency Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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B40 Non-Invasive Blood Pressure Equivalency Study

Conditions
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Blood Pressure

Intervention / Treatment
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* Device: Blood Pressure Readings on B40 Patient Monitor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blood Pressure Reading<br>Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings | Device: Blood Pressure Readings on B40 Patient Monitor<br>* Simultaneous blood pressure reading on the Investigational B40 patient monitor and DINAMAP PRO1000 patient monitor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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The focus of this study is to demonstrate that DINAMAP® SuperSTATTM NIBP algorithm has been implemented correctly without performance losses to the B40 monitor