Louisville, Colorado 80027

  • Blood Pressure

Purpose:

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 summary:

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.


Criteria:

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


NCT ID:

NCT01546285


Primary Contact:

Jeffery Conner, RN, BSN
Phone: 414.477.8374
Email: jeffrey.conner@ge.com


Backup Contact:

N/A


Location Contact:

Louisville, Colorado 80027
United States

Paul Batchelder, LRCP, RRT
Phone: 303-717-4820
Email: PBatchelder@Clinimark.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 18, 2021

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