Noninvasive Blood Pressure Monitor Evaluation Including Performance During Dysrhythmias



Status:Completed
Conditions:Healthy Studies, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases, Other
Healthy:No
Age Range:Any
Updated:5/23/2018
Start Date:November 2001
End Date:May 2010

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This protocol focuses on the evaluation of the GE noninvasive blood pressure parameter in
subjects with dysrhythmias and normal sinus rhythm. The study follows the recommendations of
the ANSI/AAMI SP10 Standard.


Inclusion Criteria:

- signed informed consent

- a patient who is undergoing a specialized procedure such as a surgical procedure or
cardiac catheterization, or during critical care monitoring in which a central
arterial catheter is in place to determine systolic, diastolic, and/or mean arterial
blood pressure values.

- ability to monitor ECG, NIBP and/or pulse oximetry

- presence of atrial fibrillation, atrial flutter, or normal sinus rhythm

Exclusion Criteria:

- any subject deemed too unstable, at the clinician's discretion, to participate in the
study

- any subject with a cardiac or vascular malformation that results in an abnormal
waveform inappropriate to be considered a reference standard

- any subject with a cardiac anomaly that would cause a disparity between aortic
pressures and the periphery.

- presence of peripheral vascular disease in arms

- inability to perform a minimum of 4 fast flushes (two at the study beginning and two
at the study end) on an arterial catheter or line in order to determine a frequency
response. The volume of fluid will not exceed a total pre-specified by the Principal
Investigator or designee.

- if the baseline arm to arm mean difference is > 10 mmHg, then the differences will be
recorded and evaluated by the Principal Investigator for possible subject exclusion
from the data analysis.

- subjects who, at the clinician's discretion, could not tolerate approximately 5 to 12,
but possibly up to 25 repeated blood pressures on each arm
We found this trial at
1
site
Milwaukee, Wisconsin 53223
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mi
from
Milwaukee, WI
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