Clinical trial NCT03535155: Ultrasound Identification Automation Study
Official title: Automated Spinal Landmark Identification to Improve Patient Safety and Efficacy During Neuraxial Anaesthesia Needle Insertion
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Spinal Anesthesia
Keywords: Ultrasound image, Neuraxial anesthesia, Landmark
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
Collaborators: name: National University of Singapore
First posted: 2018-05-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The women whose age between 21-75 years old who required spinal anaesthesia for surgical procedure.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: First attempt success rate of spinal anaesthesia
timeFrame: 12 hours
Secondary outcomes:
measure: Number of spinal attempts
timeFrame: 12 hours
measure: Time taken to identify the ligamentum flavum in the transverse view
timeFrame: 12 hours
measure: Distance from skin to ligamentum flavum
timeFrame: 12 hours
Other outcomes:
Locations:
Study officials:
affiliation: KK Women's and Children's Hospital
name: Ban Leong Sng, MBBS, MMED
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.