NCT04395573

Real Time 3D Navigation and Traditional US to Identify Epidural Space Depth in Obese Pregnant

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: European e-Learning School in Obstetric Anesthesia · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: —

Summary

The aim of this study is to assess the accuracy of the Accuro Ultrasound Device in estimating the epidural space depth compared to the Standard Ultrasound Examination and with the measured needle depth during epidural and spinal insertion in pregnant obese patients

Detailed description

SpineNav3DTM technology facilitates image interpretation of individual 2D lumbar spine scans by automating spinal bone landmark detection and depth measurements and providing a real-time assessment of scan plane orientation in 3D. All the subjects will have their lumbar area scanned for the measurements of the depth of the epidural space (recorded in cm) by two blinded anesthesiologists, one using standard ultrasounds and the other the Accuro Device. All measurements will be performed either in the sitting or in the supine position at L1/L2, L2/L3 and L3/L4 levels. Neuraxial anesthesia will be performed by using the previously marked interspace by a blinded anesthesiologist who will measure the epidural space depth during epidural or spinal insertion by marking the needle.

Conditions

• Pregnancy Related
• Obesity

Interventions

Type	Name	Description
DEVICE	Accuro	ultrasound device (Accuro, Rivanna Medical, Charlottesville, VA) with automated pattern recognition software programmed (SpineNav3DTM technology) to calculate the depth to epidural space and identify bony landmarks
DEVICE	standard ultrasound device	standard ultrasound device (o calculate the depth to epidural space and identify bony landmarks

Timeline

• Start date: 2021-03-30
• Primary completion: 2021-04-30
• Completion: 2021-04-30
• First posted: 2020-05-20
• Last updated: 2021-08-24

Locations

1 site across 1 country: Italy