Ultrasound Identification Automation Study

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03535155

Enrollment

100

Registered

2018-05-24

Start date

2016-05-01

Completion date

2027-12-31

Last updated

2026-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Anesthesia

Keywords

Ultrasound image, Neuraxial anesthesia, Landmark

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

21 Years to 75 Years

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.

Design outcomes

Primary

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

Secondary

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

Contacts

PRINCIPAL_INVESTIGATORBan Leong Sng, MBBS, MMED

KK Women's and Children's Hospital

Outcome results