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Assessment of the Clinical Utility of Non Invasive Peripheral Signal Averaged Pulse Volume

This study has been suspended.
( Revising electrodes used with new moniotoring device )

Sponsored by: University of Medicine and Dentistry New Jersey
Information provided by: University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier: NCT00143858
  Purpose

The purpose of this study is to determine the clinical usefulness of measuring the heart's pumping ability by measuring the Peripheral Pulse Volume (PPV).


Intervention
Procedure: Pulse Volume Measurement

U.S. FDA Resources

Study Type:   Observational
Study Design:   Screening, Cross-Sectional, Defined Population, Prospective Study
Official Title:   Assessment of the Clinical Utility of Non Invasive Peripheral Signal Averaged Pulse Volume

Further study details as provided by University of Medicine and Dentistry New Jersey:

Estimated Enrollment:   60
Study Start Date:   September 2004
Estimated Study Completion Date:   June 2007

Detailed Description:

Peripheral Pulse Volume (PPV) is the change in the volume of a limb that occurs when blood passes through the limb. The limb also acts as an electrical conductor whose electrical impedence changes with limb geometry and volume. Each time the heart beats, the volume of the limb segment changes, and therefore its electrical impedence changes. A plethysmograph can be used to mesure volume changes of a part of the body by producing a plethysmographic waveform. Selectively capturing a number of these plethysmographic wave forms with acceptable noise levels and averaging them using the EKG as a reference-timing signal generate a highly reproducible pulse volume signal. Signal averaged pulse volume measurement will be obtained non-invasively from the lower extremities of patient volunteers. A disposal non-occluding electrical monitoring strap will be applied to the calf of each patient. Changes in the calf's size/volume caused by changes in the patient's cardiac output and calf blood flow will result in electrical impedance changes. These changes will be recorded by an analog admittance plethysmograph attached to the lower extremity strap. The analog plethysmograph is coupled to a digital computer for signal enhancement and measurement.

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

  • Coronary care unit patients with indwelling right heart (Swan Ganz) catheters with or without intraaortic balloon assist pumping devices.
  • Congestive Heart Failure patients on and off various therapeutic inotropic agents with or without indwelling heart catheters
  • Cardiac catheterization laboratory patients undergoing prophylactic IABP in the presence of left main or diffuse unstable CAD
  • Chronic renal failure patients undergoing hemodialysis.
  • Peripheral Vascular Disease patients
  • Patients udergoing Tilt Table Testing
  • Any patients undergoing right heart catheterization

Exclusion criteria -- Non specified

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143858

Locations
United States, New Jersey
Robert Wood Johnson University Hospital    
      New Brunswick, New Jersey, United States, 08901

Sponsors and Collaborators
University of Medicine and Dentistry New Jersey

Investigators
Principal Investigator:     Sebastian Palmeri, MD     University of Medicine and Dentistry New Jersey    
  More Information


Publications:

Study ID Numbers:   4301
First Received:   August 31, 2005
Last Updated:   April 30, 2007
ClinicalTrials.gov Identifier:   NCT00143858
Health Authority:   United States: Institutional Review Board

Keywords provided by University of Medicine and Dentistry New Jersey:
Peripheral Pulse Volume  

ClinicalTrials.gov processed this record on October 10, 2008




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