Accuracy Study of a Non-Invasive Blood Pressure Cuff in Comparison to an Invasive Radial Arterial… (NCT01485120) | Clinical Trial Compass
CompletedNot Applicable
Accuracy Study of a Non-Invasive Blood Pressure Cuff in Comparison to an Invasive Radial Arterial Blood Pressure
United States34 participantsStarted 2011-12
Plain-language 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 artery.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Performance Comparison: NIBP Forearm Cuff Using SuperStat Algorithm vs. Invasive Radial Blood Pressure Reading
Timeframe: Approximately 2 hours
2
Performance Comparison: NIBP Forearm Cuff Using Classic Algorithm vs. Invasive Radial Blood Pressure Reading