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NCT Number: NCT03535155

Ultrasound Identification Automation Study

The overall aim of this study is to develop an automated spinal landmark identification system to improve patient safety and efficacy of neuraxial procedure needle insertion success.

This is a prospective cohort study to evaluate the accuracy of the automated spinal landmark identification technique using image processing system based on identification by experienced investigator using ultrasound in subjects requiring spinal anesthesia.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

21 year–75 year

Sex eligibility

Female

Study type

Observational

About this study

Neuraxial procedures are commonly performed with wide range of therapeutic and diagnostic indications. Applications include neuraxial anesthesia for surgery, epidural labour analgesia, epidural steroid injections and lumbar punctures. The current blind palpation landmark technique is known to be highly inaccurate and may increase the risk of multiple insertion attempts, patient suffering and complication rates such as spinal cord injury. A key challenge for neuraxial procedures is the correct identification of needle insertion site.

The ultrasound imaging technique has found its way to neuraxial procedures as an imaging method to detect the inner anatomical structure of the lumbar spine and is superior to the traditional palpation method. However, a full interpretation of ultrasound images requires professional training and experience.

The overall aim of this proposal is to develop an automated spinal landmark identification system to improve patient safety and efficacy of neuraxial procedure needle insertion success. The primary aim is to develop an automated spinal landmark identification algorithm using image processing system to achieve 90% 1st spinal needle success rate within 12 months. The investigators will recruit 100 subjects in a prospective cohort study to investigate the spinal needle success rate as a clinically relevant outcome.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age between 21-75 years old who required spinal anesthesia for surgical procedure;
  • Weight of 40-90kg and height of 140-180cm;
  • BMI less than 30.

Exclusion criteria

  • History of scoliosis;
  • History of spinal instrumentation;
  • Drug allergy to ultrasound transmission gel;
  • Visible wound or injury in the lumbar spine.

Treatment and study plan

Primary outcomes

  1. First attempt success rate of spinal anaesthesia

    Time frame: 12 hours

    First attempt success rate of spinal anaesthesia

Secondary outcomes

  1. Number of spinal attempts

    Time frame: 12 hours

    The number of attempts to achieve successful spinal anaesthesia

  2. Time taken to identify the ligamentum flavum in the transverse view

    Time frame: 12 hours

    Time taken to identify the ligamentum flavum in the transverse view

  3. Distance from skin to ligamentum flavum

    Time frame: 12 hours

    Distance from skin to ligamentum flavum

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Collaborators

  • National University of Singapore

Registry information

Official study title

Automated Spinal Landmark Identification to Improve Patient Safety and Efficacy During Neuraxial Anaesthesia Needle Insertion

Important dates

Study start
2016
Primary completion
2017
Study completion
2026
First posted
May 24, 2018
Registry last updated
Oct 9, 2024

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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