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 |
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.
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
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