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

Completed

• Conditions: Pregnancy Related; Obesity

• Registration Number: NCT04395573
• Lead Sponsor: European e-Learning School in Obstetric Anesthesia

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.

Study Timeline

• Study First Submitted: 2020-05-14
• Study First Submitted QC: 2020-05-19
• Study First Posted: 2020-05-20
• Study Start: 2021-03-30
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

ASST S Gerardo; 🇮🇹 Monza, Italy