N/A
N=34
Accuracy Study of a Non-Invasive Blood Pressure Cuff in Comparison to an Invasive Radial Arterial Blood Pressure
Blood Pressure
Bottom Line
View on ClinicalTrials.gov: NCT01485120 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Performance Comparison: NIBP Forearm Cuff Using SuperStat Algorithm vs. Invasive Radial Blood Pressure Reading — -0.94; 1.39 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BP monitoring using two methods (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GE Healthcare
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Performance Comparison: NIBP Forearm Cuff Using SuperStat Algorithm vs. Invasive Radial Blood Pressure Reading |
-0.94; 1.39 | — |
| PRIMARY Performance Comparison: NIBP Forearm Cuff Using Classic Algorithm vs. Invasive Radial Blood Pressure Reading |
0.68; 0.42 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01485120). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.