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Noninvasive Blood Pressure Monitor Evaluation Including Performance During Dysrhythmias

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ClinicalTrials.gov Identifier: NCT00443001
Recruitment Status : Completed
First Posted : March 5, 2007
Last Update Posted : May 21, 2018
Sponsor:
Information provided by:
GE Healthcare

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Device: Non invasive blood pressure monitor Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Noninvasive Blood Pressure Monitor Evaluation Including Performance During Dysrhythmias
Study Start Date : November 2001
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia


Intervention Details:
  • Device: Non invasive blood pressure monitor
    Updated device and software to improve performance in patients with dysrhythmia


Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00443001


Locations
United States, Wisconsin
GE Healthcare
Milwaukee, Wisconsin, United States, 53223
Sponsors and Collaborators
GE Healthcare
Investigators
Study Director: Russel Hirsch, MD Cardiac Catheterization Laboratory Division of Cardiology

Responsible Party: Jean Sesing, GE Healthcare
ClinicalTrials.gov Identifier: NCT00443001     History of Changes
Other Study ID Numbers: CS 347
First Posted: March 5, 2007    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018

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