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



Status:Completed
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:10/14/2017
Start Date:December 2011
End Date:December 2011

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

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.


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
We found this trial at
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Louisville, Colorado 80027
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