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Ultrasound Identification Automation Study

Sponsor
KK Women's and Children's Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03535155
Collaborator
National University, Singapore (Other)
100
Enrollment
80
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Automated Spinal Landmark Identification to Improve Patient Safety and Efficacy During Neuraxial Anaesthesia Needle Insertion
    Actual Study Start Date :
    May 1, 2016
    Actual Primary Completion Date :
    Apr 1, 2017
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. First attempt success rate of spinal anaesthesia [12 hours]

      First attempt success rate of spinal anaesthesia

    Secondary Outcome Measures

    1. Number of spinal attempts [12 hours]

      The number of attempts to achieve successful spinal anaesthesia

    2. Time taken to identify the ligamentum flavum in the transverse view [12 hours]

      Time taken to identify the ligamentum flavum in the transverse view

    3. Distance from skin to ligamentum flavum [12 hours]

      Distance from skin to ligamentum flavum

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 75 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • KK Women's and Children's Hospital
    • National University, Singapore

    Investigators

    • Principal Investigator: Ban Leong Sng, MBBS, MMED, KK Women's and Children's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    KK Women's and Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT03535155
    Other Study ID Numbers:
    • SHF-NHIC/MT006/2015
    First Posted:
    May 24, 2018
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by KK Women's and Children's Hospital
    Ultrasound image, Neuraxial anesthesia, Landmark

    Study Results

    No Results Posted as of Mar 31, 2022