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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04395573

Acronym

Accuro

Enrollment

Registered

2020-05-20

Start date

2021-03-30

Completion date

2021-04-30

Last updated

2021-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Pregnancy Related

Brief 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.

Interventions

DEVICEAccuro

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

DEVICEstandard ultrasound device

standard ultrasound device (o calculate the depth to epidural space and identify bony landmarks

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Inclusion criteria

* ASA Status \>III * obese BMI\>30 * term gestatio \> 37 weeks * singleton pregnancy * undergoing elective cesarean section with spinal anesthesia * requesting epidural labor analgesia

Exclusion criteria

* contraindications to neuraxial block * severe scoliosis * previous spine surgery

Design outcomes

Primary

Measure	Time frame	Description
Epidural space depth	up to 30 minutes	the depth of the epidural space (recorded in cm) is defined as the distance from the skin to the posterior complex

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026