Peripheral Vascular ResponseNCT00143858
Assessment of the Clinical Utility of Non Invasive Peripheral Signal Averaged Pulse Volume
An observational study of Peripheral Vascular Response, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peripheral Vascular Response
- What is being tested?
- Pulse Volume Measurement
- Type of treatment
- Medical device
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Oct 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
About this study
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).
Read the 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.
- Conditions
- Peripheral Vascular Response
- Being tested
- Pulse Volume Measurement
- Keywords
- Peripheral Pulse Volume
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse Volume MeasurementDevice
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startSep 2004
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
- Investigators
- Sebastian Palmeri, MD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00143858
- Sponsor's protocol ID
- 4301
- Other IDs
- investigator initiated
- Status last verified
- Aug 2009
- First submitted
- 31 Aug 2005
- Last updated
- 11 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 3570309
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Clinical Utility of Non Invasive Peripheral Signal Averaged Pulse Volume
- ClinicalTrials.gov ID
- NCT00143858
- Acronym / sponsor ID
- 4301
- Conditions
- Peripheral Vascular Response
- Keywords
- Peripheral Pulse Volume
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Study start
- Sep 2004
- Study completion
- Oct 2007 (actual)
- First posted
- 2 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulse Volume Measurementpatients 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 | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2009.
- Background: PubMed 3570309Marks 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian Palmeri, MD principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Vascular Response, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00143858, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2009.