None listed
Conditions
Brief summary
This study aims to look at a new ultrasound machine that has been purpose-designed to evaluate perfusion (blood flow through tissues). We have previously established normal ranges for a technique to measure three-dimensional ultrasound volumes called 3D Fractional Moving Blood Volume, using commercially available ultrasound machinery (GE Voluson E10). We now want to look at paired evaluations of fetal brain, kidney, liver and placental perfusion using our new machine along with the GE Voluson E10. We hypothesise that our new machine will take stable measurements of organ perfusion that will be comparable to the existing commercial machinery.
Interventions
We have developed a purpose-designed low-cost ultrasound machine to measure tissue perfusion using the technique Fractional Moving Blood Volume (FMBV). This system has been constructed using commercially available ('off-the-shelf') ultrasound componentry (ultrasound board from Telemed and probe from Noraysu), fabricated under full ISO 13485 and IEC 62304 regulatory compliance standards.
The purpose-designed machine has been specifically designed to be low-cost, to have automated settings for mor
We have developed a purpose-designed low-cost ultrasound machine to measure tissue perfusion using the technique Fractional Moving Blood Volume (FMBV). This system has been constructed using commercially available ('off-the-shelf') ultrasound componentry (ultrasound board from Telemed and probe from Noraysu), fabricated under full ISO 13485 and IEC 62304 regulatory compliance standards. The purpose-designed machine has been specifically designed to be low-cost, to have automated settings for more accurate perfusion measurement, and to have the ability to transfer ultrasound volumes for cloud-based software analysis. Other features of the machine (transducer type, power output etc are in keeping with conventional commercial ultrasound machines. We wish to test our purpose designed ultrasound machine (the ‘local’ machine) against the existing commercial machinery used to establish our normal ranges for fetoplacental perfusion (the GE Voluson E10 system). This study aims to evaluate performance of our local machine against the GE E10 using a mixed population cohort of ‘low-’ and ‘high-’ risk pregnancies. We wish to determine whether the results for 3D-FMBV perfusion evaluation (as a percentage 3D-FMBV) are equivalent to those from the GE or if the results require some form of scaling factor to be applied. Participants will be scanned using both the GE ultrasound machine and our purpose-designed system allowing direct comparison of values for fetal organ perfusion from the two machines. This will then tell us whether the new machine gives repeatable measurements, and if these are the same as the GE machine (as paired comparisons can be made within the same participants). It is anticipated that following routine evaluation of fetal wellbeing with the GE ultrasound machine (taking approximately 10-15 minutes, ultrasound volumes will be stored of fetal perfusion to the kidney, brain, liver and placenta. We anticipate approximately 10 minutes for ultrasound volume storage for each machine. Once these volumes of 3D ultrasound are stored, the patient will not be involved further in calculation of FMBV. This calculation will be undertaken on de-identified volumes on a desktop computer at a later time point. Sonographers or obstetricians with subspecialist training will undertake the scans. No additional training will be required for these participants to use the machine (as they have been involved in its development). There will be no difference in assessment for those cases determined to be 'low-risk' versus 'high-risk' as the study involves comparison of absolute values for fetal organ and placental perfusion in structurally normal fetuses.
Sponsors
UNSW Sydney
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Patients over 18 years of age with the ability to comprehend and consent to a research study, with planned birth at RHW facilitating acquisition of outcome data. For 'low-risk' cases and 'high-risk' cases we will use criteria used for our recent projects used to establish FMBV normal ranges i.e. absence of complicating factors such as growth restriction, diabetes, hypertension etc. However, for this study, 'low-risk' and 'high-risk' cases are not of great relevance as we simply aim to compare absolute values for FMBV. Inclusion criteria for 'low-risk for our recent normal range study (from the approved protocol) were: "The study will include women carrying singleton fetuses; gestational age between 28- and 42-weeks gestation, determined by the last menstrual period and confirmed by first trimester ultrasound; normal fetus on morphology scan; no complications noted on further sonography if undertaken, including intrauterine growth restriction."
Exclusion criteria
Inability to comprehend e.g. insufficient comprehension of English, or comprehension of recruitment material.
Outcome results
None listed