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 |
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.
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
1
site
Click here to add this to my saved trials