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Completed

NCT Number: NCT02982317

Automated UltraSound Software for Identification of Lumbar Vertebral Levels

A novel automated ultrasound software system has been developed which identifies for the practitioner the intervertebral spaces in the lumbar area. This study aims to investigate whether this new technology has a greater accuracy of identifying intervertebral spaces that manual palpation.

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Key information

Conditions

Anesthesia

Age range

19 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

BC Women's Hospital

Vancouver, British Columbia, V6H3N1, Canada

About this study

The use of ultrasound is one of the most accurate ways to identify the correct vertebral level for needle insertion in spinal/epidural anesthetics, however this is not commonly used. A novel automated ultrasound software system has been developed by the UBC Department of Engineering which identifies for the practitioner the intervertebral spaces in the lumbar area. This study aim to investigate whether this new technology has a greater accuracy of identifying intervertebral spaces that manual palpation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA I or II
  • ≥ 19 years old
  • Term pregnancy (≥ 37 weeks gestation age)
  • Scheduled for elective Cesarean section
  • Ability to read English in order to understand the consent form

Exclusion criteria

  • Patient refusal to participate
  • BMI ≥ 40
  • Scoliosis
  • Previous lower back surgery or known spinal abnormalities
  • Inability to palpate bony landmarks in lumbar region
  • Active labour (cervical dilatation >5cm)
  • Allergy to epidural tape, surgical paper tape, or felt pen

Treatment and study plan

Manual palpation identification lumbar spine

Procedure

Automated ultrasound technology identification

Procedure

This technology involves a standard ultrasound machine and curvilinear probe- what is novel is the software which will be connected to the ultrasound machine

Lumbar level identification gold standard ultrasound

Procedure

Primary outcomes

  1. Accuracy of identifying L3/L4 of agreement between the two techniques against the freehand US (control)

    Time frame: Within 1 hour of recuitment

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

Automated UltraSound Software for Identification of Lumbar Vertebral Levels in Obstetric Patients

Acronym: AUSSI

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 5, 2016
Registry last updated
Nov 28, 2017

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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