Accuracy Study of a Non-Invasive Blood Pressure Cuff in Comparison to an Invasive Radial Arterial Blood Pressure
This study has been completed.
Sponsor:
GE Healthcare
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01485120
First received: December 1, 2011
Last updated: February 28, 2012
Last verified: February 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Blood Pressure |
Device: Blood pressure monitoring with GE Healthcare DASH4000 and Carescape V100 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Accuracy Study of a Non-Invasive Forearm Blood Pressure Cuff in Comparison to an Invasive Radial Arterial Blood Pressure |
Further study details as provided by GE Healthcare:
Primary Outcome Measures:
- Accuracy [ Time Frame: Study Completion ] [ Designated as safety issue: No ]The primary purpose of this clinical investigation is to evaluate the accuracy of the investigational BP cuff when used with the GE DASH 4000 Patient Bedside Monitor using DINAMAP SuperStat software and the Carescape V100 using DINAMAP CLASSIC software to a reference radial arterial line.
| Enrollment: | 34 |
| Study Start Date: | December 2011 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Subjects requiring blood pressure monitoring |
Device: Blood pressure monitoring with GE Healthcare DASH4000 and Carescape V100
BP readings with marketed cuff with DASH4000 or V100 Patient Monitor and BP readings with Investigational BP cuff and DASH4000 Patient Monitor and V100 Patient Monitor
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | GE Healthcare |
| ClinicalTrials.gov Identifier: | NCT01485120 History of Changes |
| Other Study ID Numbers: | 118.02-2011-GES-0007 |
| Study First Received: | December 1, 2011 |
| Last Updated: | February 28, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by GE Healthcare:
|
Blood pressure (low, normal, high) |
ClinicalTrials.gov processed this record on May 19, 2013