- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00143858
Assessment of the Clinical Utility of Non Invasive Peripheral Signal Averaged Pulse Volume
August 6, 2009 updated by: University of Medicine and Dentistry of New Jersey
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
16
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Jersey
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New Brunswick, New Jersey, United States, 08901
- Robert Wood Johnson University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sebastian Palmeri, MD, Rutgers, the State University of New Jersey
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2004
Study Completion (Actual)
October 1, 2007
Study Registration Dates
First Submitted
August 31, 2005
First Submitted That Met QC Criteria
September 1, 2005
First Posted (Estimate)
September 2, 2005
Study Record Updates
Last Update Posted (Estimate)
August 11, 2009
Last Update Submitted That Met QC Criteria
August 6, 2009
Last Verified
August 1, 2009
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 4301
- Investigator Initiated
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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