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

This study has been completed.
Sponsor:
Information provided by:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00143858
First received: August 31, 2005
Last updated: August 6, 2009
Last verified: August 2009
  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).


Condition Intervention
Peripheral Vascular Response
Device: Pulse Volume Measurement

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Assessment of the Clinical Utility of Non Invasive Peripheral Signal Averaged Pulse Volume

Further study details as provided by Rutgers, The State University of New Jersey:

Enrollment: 16
Study Start Date: September 2004
Study Completion Date: October 2007
Intervention Details:
    Device: Pulse Volume Measurement
    patients will wear a newly designed calf monitor that will be hooked up to a computer that will monitor leg peripheral pulse volumes which will then be correlated to pressures obtained with Swan Ganz monitoring. The calf monitor is gut two bands with sensors that are wrapped around the ankle and below the knww
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 measure 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
Sampling Method:   Non-Probability Sample
Study Population

Patient who are having a right heart catherization done for other diagnostic purposes or patient in the critical care units who have Swan Ganz catheters in place for other medical management

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 undergoing Tilt Table Testing
  • Any patients undergoing right heart catheterization Exclusion criteria -- Non specified
  Contacts and Locations
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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 of New Jersey
Investigators
Principal Investigator: Sebastian Palmeri, MD Rutgers, The State University of New Jersey
  More Information

Publications:
Responsible Party: Sebastian T. Palmeri, MD -- Principal Investigator, UMDNJ-Robert Wood Johnson Medical School
ClinicalTrials.gov Identifier: NCT00143858     History of Changes
Other Study ID Numbers: 4301, investigator initiated
Study First Received: August 31, 2005
Last Updated: August 6, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
Peripheral Pulse Volume

ClinicalTrials.gov processed this record on July 28, 2014