Validation of Pulse Wave Doppler Demodulation Algorithm for the Continuous, Non-invasive Measurement of Blood Flow Velocity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Virginia
ClinicalTrials.gov Identifier:
NCT01750125
First received: December 12, 2012
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

The investigators hypothesize that performance of fast-Fourier transformation on the raw Doppler signals obtained from ascending aortic blood flow will recreate the pulse wave Doppler trace visualized on modern echocardiography machines, and that this will allow for the measurement and recording of vascular flow waveforms


Condition Intervention
Focus is on Healthy Subjects
Device: measure ascending aortic blood flow with pulse wave Doppler

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Comparison between estimated arterial flow waveform and pulse wave Doppler trace [ Time Frame: day of procedure ] [ Designated as safety issue: No ]
    Estimated arterial flow waveform using fast Fourier transformation (FFT) will be compared to the pulse wave Doppler trace from the device


Enrollment: 10
Study Start Date: December 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Healthy subjects
In these health subjects we will measure ascending aortic blood flow with pulse wave Doppler and also record the raw audio of the Doppler signal
Device: measure ascending aortic blood flow with pulse wave Doppler

Detailed Description:

Currently there is no commercially available mechanism for the measurement of blood flow velocity waveforms non-invasively. Blood flow velocity waveforms require the use of invasive catheters, thus precluding clinical use. Such information would allow the researcher / practitioner the ability to continuously measure blood flow, pulse pressure, and the pulsatility index of any vascular structure accessible by ultrasound with minimal additional risk to the subject / patient. This data, when combined with arterial blood pressure data, could also be used to measure peripheral pressure volume loops as well as aortic vascular impedance, both of which cannot be currently measured in vivo.

The ability to measure blood flow velocity waveforms at high temporal resolution would provide clinicians with new tools for hemodynamic optimization (both a novel means of estimating myocardial oxygen consumption [pressure volume area] as well as afterload [aortic vascular impedance]) and researchers with the ability to conduct hemodynamic experiments that were not previously possible. This work will serve as the foundation for several other related projects which depend on the ability to continuously record blood flow velocity waveforms.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy subjects 18-65

Criteria

Inclusion Criteria:

  • 18-65
  • Healthy

Exclusion Criteria:

  • Cannot visualize ascending aorta with ultrasound
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01750125

Locations
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
  More Information

Additional Information:
No publications provided

Responsible Party: University of Virginia
ClinicalTrials.gov Identifier: NCT01750125     History of Changes
Other Study ID Numbers: 16305
Study First Received: December 12, 2012
Last Updated: April 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
Doppler

ClinicalTrials.gov processed this record on August 20, 2014