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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00143858
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : August 11, 2009
Information provided by:
Rutgers, The State University of New Jersey

Brief Summary:
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 or disease Intervention/treatment
Peripheral Vascular Response Device: Pulse Volume Measurement

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.

Study Type : Observational
Actual Enrollment : 16 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Assessment of the Clinical Utility of Non Invasive Peripheral Signal Averaged Pulse Volume
Study Start Date : September 2004
Actual 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

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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

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 identifier (NCT number): NCT00143858

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
Principal Investigator: Sebastian Palmeri, MD Rutgers, The State University of New Jersey

Responsible Party: Sebastian T. Palmeri, MD -- Principal Investigator, UMDNJ-Robert Wood Johnson Medical School Identifier: NCT00143858     History of Changes
Other Study ID Numbers: 4301
investigator initiated
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: August 11, 2009
Last Verified: August 2009

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