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

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

Study Overview

• Status: Completed
• Conditions: Obesity; Pregnancy Related
• Intervention / Treatment: Device: Accuro; Device: standard ultrasound device

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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Italy
  • Monza, Italy
    • ASST S Gerardo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Pregnant Patients undergoing elective cesarean section or requesting labor epidural analgesia

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: European e-Learning School in Obstetric Anesthesia
• Collaborators: University of Milano Bicocca

Publications and helpful links

General Publications

• Seligman KM, Weiniger CF, Carvalho B. The Accuracy of a Handheld Ultrasound Device for Neuraxial Depth and Landmark Assessment: A Prospective Cohort Trial. Anesth Analg. 2018 Jun;126(6):1995-1998. doi: 10.1213/ANE.0000000000002407.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 30, 2021
• Primary Completion (ACTUAL): April 30, 2021
• Study Completion (ACTUAL): April 30, 2021

Study Registration Dates

• First Submitted: May 14, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (ACTUAL): May 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 24, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: EESOA6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No