Noninvasive Blood Pressure Monitor Evaluation Including Performance During Dysrhythmias

Study Overview
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Brief Summary
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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.

Official Title
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Noninvasive Blood Pressure Monitor Evaluation Including Performance During Dysrhythmias

Conditions
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Healthy

Intervention / Treatment
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* Device: Non invasive blood pressure monitor


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Non invasive blood pressure monitor|Updated device and software to improve performance in patients with dysrhythmia|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of early systolic, systolic, and diastolic blood pressure, MAP and pulse rate as collected by an investigational non-invasive blood pressure device versus reference standards |  | 1-4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-Invasive Blood Pressure, Sinus Rhythm, Oscillometric, Invasive Blood Pressure, AAMI/ANSI SP10 Standard, Compliance with ANSI/AAMI SP10 2002 standard