B40 Non-Invasive Blood Pressure Equivalency Study

General Electric (GE)

Status: Completed

Conditions: Blood Pressure

Treatments: Device: Blood Pressure Readings on B40 Patient Monitor

Study type: Interventional

Funder types: Industry

Identifiers

NCT01546285

118.04-2011-GES-0002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 3 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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66 participants in 1 patient group

Blood Pressure Reading

Experimental group

Description:

Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings

Treatment:

Device: Blood Pressure Readings on B40 Patient Monitor