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Completed

NCT Number: NCT04395573

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

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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Key information

Conditions

Pregnancy Related Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

ASST S Gerardo

Monza, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Accuro

Device

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

Other names: wireless portable ultrasound device

standard ultrasound device

Device

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

Primary outcomes

  1. Epidural space depth

    Time frame: 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

Sponsors and collaborators

Lead sponsor

European e-Learning School in Obstetric Anesthesia

Other

Collaborators

  • University of Milano Bicocca

Registry information

Acronym: Accuro

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 20, 2020
Registry last updated
Aug 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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