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

Obesity Clinical Trial

— Accuro  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04395573
• Other study ID #: EESOA6
• Status: Completed
• Start date: March 30, 2021
• Est. completion date: April 30, 2021

Study information

• Verified date: August 2021
• Source: European e-Learning School in Obstetric Anesthesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Pregnancy Related

Intervention

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

Locations

Country	Name	City	State
Italy	ASST S Gerardo	Monza

Sponsors (2)

Lead Sponsor	Collaborator
European e-Learning School in Obstetric Anesthesia	University of Milano Bicocca

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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