Accuracy Study of a Non-Invasive Blood Pressure Cuff in Comparison to an Invasive Radial Arterial Blood Pressure

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01485120

Locations
United States, Colorado
Clinimark
Louisville, Colorado, United States, 80027
Sponsors and Collaborators
GE Healthcare
Investigators
Principal Investigator: David Ransom, MD Clinimark, LLC
  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 August 19, 2014