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

E

European e-Learning School in Obstetric Anesthesia

Status

Completed

Conditions

Pregnancy Related
Obesity

Treatments

Device: Accuro
Device: standard ultrasound device

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

50 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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