Validation of Pulse Wave Doppler Demodulation Algorithm for the Continuous, Non-invasive Measurement of Blood Flow Velocity
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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 |
- 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
| Estimated Enrollment: | 10 |
| Study Start Date: | December 2012 |
| Estimated 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 |
Healthy subjects 18-65
Inclusion Criteria:
- 18-65
- Healthy
Exclusion Criteria:
- Cannot visualize ascending aorta with ultrasound
Contacts and Locations| Contact: Robert H Thiele, MD | 434-924-2283 | rht7w@virginia.edu |
| United States, Virginia | |
| University of Virginia | Recruiting |
| Charlottesville, Virginia, United States, 22908 | |
| Contact: Robert H Thiele, MD 434-924-2283 rht7w@virginia.edu | |
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: | December 13, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Virginia:
|
Doppler |
ClinicalTrials.gov processed this record on May 19, 2013