Spinal AnesthesiaNCT03535155
Ultrasound Identification Automation Study
An observational study of Spinal Anesthesia, run by KK Women's and Children's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Spinal Anesthesia
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2016to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The women whose age between 21-75 years old who required spinal anaesthesia for surgical procedure.
Who may be able to join
- 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.
Who cannot join
- History of scoliosis;
- History of spinal instrumentation;
- Drug allergy to ultrasound transmission gel;
- Visible wound or injury in the lumbar spine.
About this study
Official title: 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.
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.
- Conditions
- Spinal Anesthesia
- Keywords
- Ultrasound image, Neuraxial anesthesia, Landmark
What is being measured
The primary outcome is the main question the study is designed to answer.
First attempt success rate of spinal anaesthesia
First attempt success rate of spinal anaesthesia
Measured: 12 hours
Secondary outcomes (3)
Number of spinal attempts
The number of attempts to achieve successful spinal anaesthesia
Measured: 12 hours
Time taken to identify the ligamentum flavum in the transverse view
Time taken to identify the ligamentum flavum in the transverse view
Measured: 12 hours
Distance from skin to ligamentum flavum
Distance from skin to ligamentum flavum
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start1 May 2016
- Primary completion1 Apr 2017
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Collaborators
- National University of Singapore
- Responsible party
- Principal investigator, Sng Ban Leong, KK Women's and Children's Hospital
- Investigators
- Ban Leong Sng, MBBS, MMED, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03535155
- Sponsor's protocol ID
- SHF-NHIC/MT006/2015
- Status last verified
- Aug 2026
- First submitted
- 13 May 2018
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Spinal Landmark Identification to Improve Patient Safety and Efficacy During Neuraxial Anaesthesia Needle Insertion
- ClinicalTrials.gov ID
- NCT03535155
- Acronym / sponsor ID
- SHF-NHIC/MT006/2015
- Conditions
- Spinal Anesthesia
- Keywords
- Ultrasound image, Neuraxial anesthesia, Landmark
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Collaborators
- National University of Singapore
- Study start
- 1 May 2016 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The women whose age between 21-75 years old who required spinal anaesthesia for surgical procedure.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- History of scoliosis;
- History of spinal instrumentation;
- Drug allergy to ultrasound transmission gel;
- Visible wound or injury in the lumbar spine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
First attempt success rate of spinal anaesthesia
Time frame: 12 hours
First attempt success rate of spinal anaesthesia
3 secondary outcomes
Number of spinal attempts
Time frame: 12 hours
Time taken to identify the ligamentum flavum in the transverse view
Time frame: 12 hours
Distance from skin to ligamentum flavum
Time frame: 12 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Derived from this study: PubMed 30991949Oh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ban Leong Sng, MBBS, MMED principal investigator
KK Women's and Children's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Anesthesia, run by KK Women's and Children's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First attempt success rate of spinal anaesthesia (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03535155, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.