Noninvasive Blood Pressure Monitor Evaluation Including Performance During Dysrhythmias

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by GE Healthcare.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00443001
First received: March 2, 2007
Last updated: July 23, 2008
Last verified: July 2008
  Purpose

This protocol focuses on the evaluation of the GE noninvasive blood pressure parameter in subjects with dysrhythmias and normal sinus rhythm. The study follows the recommendations of the ANSI/AAMI SP10 Standard.


Condition Intervention
Healthy
Device: Non invasive blood pressure monitor

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Noninvasive Blood Pressure Monitor Evaluation Including Performance During Dysrhythmias

Resource links provided by NLM:


Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • Comparison of early systolic, systolic, and diastolic blood pressure, MAP and pulse rate as collected by an investigational non-invasive blood pressure device versus reference standards [ Time Frame: 1-4 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2001
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Non invasive blood pressure monitor
    Updated device and software to improve performance in patients with dysrhythmia
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • signed informed consent
  • a patient who is undergoing a specialized procedure such as a surgical procedure or cardiac catheterization, or during critical care monitoring in which a central arterial catheter is in place to determine systolic, diastolic, and/or mean arterial blood pressure values.
  • ability to monitor ECG, NIBP and/or pulse oximetry
  • presence of atrial fibrillation, atrial flutter, or normal sinus rhythm

Exclusion Criteria:

  • any subject deemed too unstable, at the clinician's discretion, to participate in the study
  • any subject with a cardiac or vascular malformation that results in an abnormal waveform inappropriate to be considered a reference standard
  • any subject with a cardiac anomaly that would cause a disparity between aortic pressures and the periphery.
  • presence of peripheral vascular disease in arms
  • inability to perform a minimum of 4 fast flushes (two at the study beginning and two at the study end) on an arterial catheter or line in order to determine a frequency response. The volume of fluid will not exceed a total pre-specified by the Principal Investigator or designee.
  • if the baseline arm to arm mean difference is > 10 mmHg, then the differences will be recorded and evaluated by the Principal Investigator for possible subject exclusion from the data analysis.
  • subjects who, at the clinician's discretion, could not tolerate approximately 5 to 12, but possibly up to 25 repeated blood pressures on each arm
  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: NCT00443001

Contacts
Contact: Diego Lozano (813) 887-2055
Contact: Andrea Stebor (813) 887-2035

Locations
United States, Florida
Recruiting
Tampa, Florida, United States, 33614
Contact: Diego Lozano    (813) 887-2055      
Sponsors and Collaborators
GE Healthcare
Investigators
Study Director: Russel Hirsch, MD Cardiac Catheterization Laboratory Division of Cardiology
  More Information

No publications provided

Responsible Party: Andrea Stebor, GE Healthcare
ClinicalTrials.gov Identifier: NCT00443001     History of Changes
Other Study ID Numbers: CS 347
Study First Received: March 2, 2007
Last Updated: July 23, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by GE Healthcare:
Non-Invasive Blood Pressure
Sinus Rhythm
Oscillometric
Invasive Blood Pressure
AAMI/ANSI SP10 Standard
Compliance with ANSI/AAMI SP10 2002 standard

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 27, 2014