Status:
COMPLETED
Accuracy Study of a Non-Invasive Blood Pressure Cuff in Comparison to an Invasive Radial Arterial Blood Pressure
Lead Sponsor:
GE Healthcare
Conditions:
Blood Pressure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 arte...
Detailed Description
Blood pressure reading from the cuff will provide similar blood pressure as a radial artery.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01485120
Start Date
December 1 2011
End Date
December 1 2011
Last Update
May 31 2019
Active Locations (1)
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1
Clinimark
Louisville, Colorado, United States, 80027