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Active, not recruitingNCT03535155Updated Aug 7, 2026

Ultrasound Identification Automation Study

An observational study in Spinal Anesthesia, sponsored by KK Women's and Children's Hospital. Active, not recruiting. Open to female participants aged 21 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-07.

Sponsored by KK Women's and Children's Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
21 Years to 75 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Spinal Anesthesia

Keywords

  • Ultrasound image, Neuraxial anesthesia, Landmark
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In context

Lead sponsor

KK Women's and Children's Hospital is the lead sponsor of 136 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 75 Years
Sexes eligible
Female
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.

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. First attempt success rate of spinal anaesthesia

    First attempt success rate of spinal anaesthesia

    Time frame: 12 hours

Secondary outcomes

  1. Number of spinal attempts

    The number of attempts to achieve successful spinal anaesthesia

    Time frame: 12 hours

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

    Time taken to identify the ligamentum flavum in the transverse view

    Time frame: 12 hours

  3. Distance from skin to ligamentum flavum

    Distance from skin to ligamentum flavum

    Time frame: 12 hours

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Study locations

No study locations are listed for this record.

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References and documents

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. PubMed 30991949 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03535155
Lead sponsor
KK Women's and Children's Hospital
Collaborators
National University of Singapore
Responsible party
Sng Ban Leong (Principal Investigator, KK Women's and Children's Hospital) — Principal investigator
First posted
May 24, 2018
Start date
May 1, 2016
Primary completion
Apr 1, 2017
Completion
Dec 31, 2027 (estimated)
Last update
Aug 7, 2026

Study contacts

Ban Leong Sng, MBBS, MMED
principal investigator · KK Women's and Children's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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