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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-30

Study Completion Date

2021-04-30

Brief Summary

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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

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Detailed Description

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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

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Pregnancy Related Obesity

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type DEVICE

standard ultrasound device

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

Intervention Type DEVICE

Other Intervention Names

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wireless portable ultrasound device

Eligibility Criteria

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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