Clinical trial NCT00143858: Assessment of the Clinical Utility of Non Invasive Peripheral Signal Averaged Pulse Volume
Official title: Assessment of the Clinical Utility of Non Invasive Peripheral Signal Averaged Pulse Volume
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Vascular Response
Keywords: Peripheral Pulse Volume
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2005-09-02
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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

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).

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Sebastian Palmeri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marks LA. Digital enhancement of the peripheral admittance plethysmogram. IEEE Trans Biomed Eng. 1987 Mar;34(3):192-8. doi: 10.1109/tbme.1987.325944. No abstract available.