B40 Non-Invasive Blood Pressure Equivalency Study

GE Healthcare66 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Blood Pressure

Interventions

Blood Pressure Readings on B40 Patient MonitorDEVICE

Simultaneous blood pressure reading on the Investigational B40 patient monitor and DINAMAP PRO1000 patient monitor

Eligibility

Sex: ALLMin age: 3 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Clinimark

Louisville, Colorado, United States

Outcomes

Primary Outcomes

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.

Time frame: End of each blood pressure reading

Data from ClinicalTrials.gov

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