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


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Pulse oximetry


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

This study is currently recruiting patients.
Verified by University of Medicine and Dentistry New Jersey August 2005

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

MedlinePlus consumer health information 

Study Type: Observational
Study Design: Screening, Cross-Sectional, Defined Population, Prospective Study

Further Study Details: 

Expected Total Enrollment:  60

Study start: September 2004;  Expected completion: December 2006
Last follow-up: December 2006;  Data entry closure: December 2006

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 mumber of these plethysmographic wave forms with acceptable noise levels and averaging them using the EKG as a reference-timining 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   -   75 Years,  Genders Eligible for Study:  Both
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.
  • Periheral Vascular Disease patients
  • Patients udergoing Tilt Table Testing
  • Any patients undergoing right heart catheterization

Exclusion criteria -- Non specified

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00143858

Sebastian Pamleri, MD      732-235-7853    palmerse@umdnj.edu

New Jersey
      Robert Wood Johnson University Hospital, New Brunswick,  New Jersey,  08901,  United States; Recruiting
Laurie Casazza, RN  732-235-8694    casazzla@umdnj.edu 
Sebastian Palmeri, MD,  Principal Investigator

Study chairs or principal investigators

Sebastian Palmeri, MD,  Principal Investigator,  University of Medicine and Dentistry New Jersey   

More Information

Publications

Marks LA. Digital enhancement of the peripheral admittance plethysmogram. IEEE Trans Biomed Eng. 1987 Mar;34(3):192-8. No abstract available.

Study ID Numbers:  4301
Last Updated:  September 1, 2005
Record first received:  August 31, 2005
ClinicalTrials.gov Identifier:  NCT00143858
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-06


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Page Updated: February 11, 2005
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