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OpenTrials
Completed

NCT Number: NCT01750125

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

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

Completed

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Key information

Conditions

Focus is on Healthy Subjects

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Virginia

Charlottesville, Virginia, 22908, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-65
  • Healthy

Exclusion criteria

  • Cannot visualize ascending aorta with ultrasound

Treatment and study plan

measure ascending aortic blood flow with pulse wave Doppler

Device

Primary outcomes

  1. Comparison between estimated arterial flow waveform and pulse wave Doppler trace

    Time frame: day of procedure

    Estimated arterial flow waveform using fast Fourier transformation (FFT) will be compared to the pulse wave Doppler trace from the device

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 17, 2012
Registry last updated
May 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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