Ultrasound Identification Automation Study

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Spinal Anesthesia

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 Type: Observational
• Enrollment (Estimated): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

The women whose age between 21-75 years old who required spinal anaesthesia for surgical procedure.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First attempt success rate of spinal anaesthesia	First attempt success rate of spinal anaesthesia	12 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of spinal attempts	The number of attempts to achieve successful spinal anaesthesia	12 hours
Time taken to identify the ligamentum flavum in the transverse view	Time taken to identify the ligamentum flavum in the transverse view	12 hours
Distance from skin to ligamentum flavum	Distance from skin to ligamentum flavum	12 hours

Collaborators and Investigators

• Sponsor: KK Women's and Children's Hospital
• Collaborators: National University of Singapore
• Investigators: Principal Investigator: Ban Leong Sng, MBBS, MMED, KK Women's and Children's Hospital

Publications and helpful links

General Publications

• Oh TT, Ikhsan M, Tan KK, Rehena S, Han NR, Sia ATH, Sng BL. A novel approach to neuraxial anesthesia: application of an automated ultrasound spinal landmark identification. BMC Anesthesiol. 2019 Apr 16;19(1):57. doi: 10.1186/s12871-019-0726-6.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 13, 2018
• First Submitted That Met QC Criteria: May 13, 2018
• First Posted (Actual): May 24, 2018

Study Record Updates

• Last Update Posted (Actual): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 8, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Ultrasound image, Neuraxial anesthesia, Landmark
• Other Study ID Numbers: SHF-NHIC/MT006/2015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No