Accuracy Study of a Non-Invasive Blood Pressure Cuff in Comparison to an Invasive Radial Arterial Blood Pressure

Study Overview
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Brief Summary
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The purpose of this study is to establish the performance of a blood pressure cuff. The hypothesis is that the blood pressure reading from the cuff will provide similar blood pressure as a radial artery.

Detailed Description
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Blood pressure reading from the cuff will provide similar blood pressure as a radial artery.

Official Title
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Accuracy Study of a Non-Invasive Forearm Blood Pressure Cuff in Comparison to an Invasive Radial Arterial Blood Pressure

Conditions
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Blood Pressure

Intervention / Treatment
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* Device: BP monitoring using two methods


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to provide written informed consent or have a legally authorized representative provide written informed consent Any volunteer subjects ≥ 18 years of age Subject must have the presence of normal sinus rhythm on ECG Subject will return for follow-up visit from 5 days to 8 days after study procedure Exclusion Criteria: Any subject who is unable to provide written informed consent Any subject with the presence of peripheral vascular disease in either arm Any subject that demonstrates an initial NIBP screening for a blood pressure distribution range that has already been filled. Any subject who cannot tolerate 21 repeated BP measurements Any subjects with clotting or bleeding disorders Any subjects taking medications that are considered anticoagulants or blood thinners (For example, Clopidogrel, Warfarin, Dipyridamole, Aspirin, and Enoxaparin) Any subject who is unable to have arterial line placed in the radial artery Any subject that cannot tolerate 4 fast flushes for the frequency response Any female subjects pregnant or lactating Any subject that has previously participated in this study Any subjects that cannot return 5 to 8 days post study procedure for a follow-up visit

Ages Eligible for Study
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Minimum Age: 18 Years

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Blood Pressure monitoring<br>Blood Pressure (BP) monitoring using invasive arterial insertion as a standard reference, and an investigational, non-invasive blood pressure (NIBP) monitoring cuff. Data obtained from the cuff used the SuperSTAT NIBP algorithm and the Classic NIBP algorithm for output. | Device: BP monitoring using two methods<br>* BP readings from participant using invasive radial arterial line, Non-invasive cuff with SuperSTAT NIBP algorithm, and Non-invasive cuff with Classic NIBP algorithm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance Comparison: NIBP Forearm Cuff Using SuperStat Algorithm vs. Invasive Radial Blood Pressure Reading | NIBP Forearm cuff systolic and diastolic values using SuperStat algorithm compared to invasive radial blood pressure systolic and diastolic values (both obtained simultaneously). | Approximately 2 hours | 
| Performance Comparison: NIBP Forearm Cuff Using Classic Algorithm vs. Invasive Radial Blood Pressure Reading | NIBP Forearm cuff systolic and diastolic values using Classic algorithm difference compared to invasive radial blood pressure readings (both readings obtained simultaneously). | Approximately 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood pressure (low, normal, high)