B40 Non-Invasive Blood Pressure Equivalency Study

Completed · Not applicable

Conditions studied: Blood Pressure

In brief

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.

Key facts

Study ID

NCT01546285

Run by

GE Healthcare

People needed

66

Starts

2012-03-01

Expected to finish

2012-03-01

Last updated by the study team

2013-06-21

Who can join

Age: 3 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinimark — Louisville, Colorado, United States

Full record on ClinicalTrials.gov

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