Spinal AnaesthesiauSINENCT03687411
An Ultrasound Guided Automated Spinal Landmark Identification System
A study testing Neuraxial ultrasonography in people with Spinal Anaesthesia and Obesity, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
Neuraxial ultrasonography has been shown a safe and effective technique to enhance the overall success rate of lumbar puncture and reduce the number of injection attempts. However, the current blind palpation landmark technique is known to be highly inaccurate and may increase the risk of multiple insertion attempts… Read more about this study
- Who is it for?
- Ages 21 to 75 years, women only
- Conditions the study is for
- Spinal Anaesthesia, Obesity
- What is being tested?
- Neuraxial ultrasonography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSingapore
- Study dates
- 24 May 2018to 31 Dec 2027
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First phase:
- Age 21 - 75 years old patients who require neuraxial anesthesia for surgical procedure;
- Normal body mass index (Weight 40-90 kg, Height 140-180cm).
- Second-fourth phases:
- Obese patients aged between 21-75 years old;
- body mass index more 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
KK Women's and Children's Hospital
Singapore, 229899
Ban Leong Sng, MBBS, MMED, +6563941081, sng.ban.leong@singhealth.com.sg
About this study
Official title: Development of an Ultrasound Guided Automated Spinal Landmark Identification System (uSINE Study)
Neuraxial ultrasonography has been shown a safe and effective technique to enhance the overall success rate of lumbar puncture and reduce the number of injection attempts. However, 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. Various clinical studies have confirmed the effectiveness of ultrasound imaging compared with the traditional palpation method. However, none of the present system can achieve real-time guidance.
The overall aim of this proposal is to develop an ultrasound guided automated spinal landmark identification with real-time neuraxial needle insertion system (uSINE) to improve patient safety and efficacy of neuraxial procedure needle insertion success. This will be achieved in 4 phases of technology development and clinical trial phases. The investigators will recruit 20 subjects in a prospective cohort study to investigate the spinal needle first attempt success rate as a clinically relevant outcome. The secondary aim is to develop an automated spinal landmark identification algorithm using image processing to identify spinal landmarks in 50 obese patients. Third phase objective will be to obtain clinical data, and evaluation and annotation of the clinical data of spinal ultrasonography in 65 obese patients (BMI > 30kg/m2), whereas the fourth phase will measure the uSINE identification accuracy and first-attempt puncture success rate of uSINE in a clinical study of 65 obese patients (BMI > 30kg/m2).
Read the detailed description
This is a prospective cohort study to evaluate the efficacy and accuracy of ultrasound guided automated spinal landmark identification with real-time neuraxial needle insertion system (uSINE).
The subjects assume a seated position and the lower back is exposed. Ultrasound gel will be applied to the lower back lumbar spine and the investigator will place an ultrasound curved array probe around the sacral region. The graphical interface of the software, integrated with the wireless ultrasound probe and ultrasound machine, will inform the investigator when the software has positively identified the sacrum. The investigator will then move the probe in a steady vertical upward longitudinal direction until the L3/4 interspinous space is identified by the program. The ultrasound algorithm will identify the skin surface marking. The longitudinal section of the scan will be completed and the investigator will turn the probe 90 degrees clockwise around the probe center to the transverse view.
The transverse scan consists of minimal vertical movements by the investigator who will obtain images using the ultrasound probe. The software will signal when the correct identification of the ligamentum flavum is visualized. The scan sequence will be completed.
The first phase will involve 20 non-obese patients who are undergoing neuraxial anaesthesia or analgesia. The system is used prior and during needle insertion to provide real-time guidance for the anaesthetists. The neuraxial needle insertion is conducted manually by the anaesthetist as per routine practice.
In the second phase, 50 obese patients (body mass index more than 30) will be recruited to investigate and develop an "obesity" mode visualisation of the ultrasound guided automated spinal landmark identification. This will be to advance the technology to evaluate more difficult anatomy and more complex neuraxial needle insertion in future work plan. The patients' back will be scanned to obtain the images. The neuraxial needle insertion is conducted manually (i.e. independent of the ultrasound results) by the anaesthetist as per hospital routine practice.
The third phase involve data collection and annotation of spinal ultrasonography in 65 obese patients, followed by a fourth phase to measure the uSINE identification accuracy and first-attempt puncture success rate in 65 obese patients.
- Conditions
- Spinal Anaesthesia, Obesity
- Being tested
- Neuraxial ultrasonography
- Keywords
- spinal anaesthesia, Neuraxial ultrasonography, landmark identification
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuraxial ultrasonographyProcedure or surgery
Ultrasound gel is applied to lower back lumbar spine of patient and placed with an ultrasound probe around the sacral region. The graphical interface of the software integrated with ultrasound machine will help identify the sacrum. The probe is moved in until the L3/4 interspinous space is identified for skin surface marking. Once the longitudinal scan is completed, the investigator will turn the probe 90° clockwise for transverse scan to identify ligamentum flavum.
| Study group | Role | What they receive |
|---|---|---|
| ULTRA-SINE (phases 1-4) | Experimental | There will be four phases in this proposed uSINE system. In first phase attending anaesthetist will use the automated spinal landmark system for neuraxial needle insertion to place the neuraxial anaesthesia in non-obese patients.
For the second phase, obese patients will have ultrasound scan of their lumbar back and no needle insertion is involved.
In third phase, conventional ultrasonography is used prior to the needle insertion, and needle insertion is conducted manually as per routine practice. The images collected in the system will be used for annotation and evaluation which serves as training material for uSINE to optimize its algorithm to improve landmark identification for obese patients. The fourth phase will have uSINE system used prior to the needle insertion, with the neuraxial needle insertion conducted manually as per routine practice. The identification accuracy and first-attempt puncture success rate of uSINE will be determined. Receives: Procedure: Neuraxial ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
First attempt success rate of spinal anaesthesia
The rate of cases achieving successful spinal anaesthesia at first attempt of insertion
Measured: 12 hours
Secondary outcomes (3)
Number of spinal attempts
The number of attempts to achieve successful spinal anaesthesia
Measured: 12 hours
Time taken for ligamentum flavum identification
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 as detected by the algorithm
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 posted27 Sep 2018
- Study start24 May 2018
- Primary completion14 Oct 2026 (estimated)
- 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 AnaesthesiaStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sng Ban Leong, KK Women's and Children's Hospital
- Investigators
- Ban L Sng, FANZCA, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687411
- Sponsor's protocol ID
- NHIC-I2D-1708180
- Acronym
- uSINE
- Status last verified
- Aug 2026
- First submitted
- 22 Aug 2018
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
In Chan JJ, Ma J, Leng Y, Tan KK, Tan CW, Sultana R, Sia ATH, Sng BL. Machine learning approach to needle insertion site identification for spinal anesthesia in obese patients. BMC Anesthesiol. 2021 Oct 18;21(1):246. doi: 10.1186/s12871-021-01466-8.
PubMed 34663224
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
- Development of an Ultrasound Guided Automated Spinal Landmark Identification System (uSINE Study)
- ClinicalTrials.gov ID
- NCT03687411
- Acronym / sponsor ID
- uSINE / NHIC-I2D-1708180
- Conditions
- Spinal Anaesthesia, Obesity
- Keywords
- spinal anaesthesia, Neuraxial ultrasonography, landmark identification
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 24 May 2018 (actual)
- Primary completion
- 14 Oct 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Sep 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.
Neuraxial ultrasonography has been shown a safe and effective technique to enhance the overall success rate of lumbar puncture and reduce the number of injection attempts. However, 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. Various clinical studies have confirmed the effectiveness of ultrasound imaging compared with the traditional palpation method. However, none of the present system can achieve real-time guidance.
The overall aim of this proposal is to develop an ultrasound guided automated spinal landmark identification with real-time neuraxial needle insertion system (uSINE) to improve patient safety and efficacy of neuraxial procedure needle insertion success. This will be achieved in 4 phases of technology development and clinical trial phases. The investigators will recruit 20 subjects in a prospective cohort study to investigate the spinal needle first attempt success rate as a clinically relevant outcome. The secondary aim is to develop an automated spinal landmark identification algorithm using image processing to identify spinal landmarks in 50 obese patients. Third phase objective will be to obtain clinical data, and evaluation and annotation of the clinical data of spinal ultrasonography in 65 obese patients (BMI > 30kg/m2), whereas the fourth phase will measure the uSINE identification accuracy and first-attempt puncture success rate of uSINE in a clinical study of 65 obese patients (BMI > 30kg/m2).
Detailed description
This is a prospective cohort study to evaluate the efficacy and accuracy of ultrasound guided automated spinal landmark identification with real-time neuraxial needle insertion system (uSINE).
The subjects assume a seated position and the lower back is exposed. Ultrasound gel will be applied to the lower back lumbar spine and the investigator will place an ultrasound curved array probe around the sacral region. The graphical interface of the software, integrated with the wireless ultrasound probe and ultrasound machine, will inform the investigator when the software has positively identified the sacrum. The investigator will then move the probe in a steady vertical upward longitudinal direction until the L3/4 interspinous space is identified by the program. The ultrasound algorithm will identify the skin surface marking. The longitudinal section of the scan will be completed and the investigator will turn the probe 90 degrees clockwise around the probe center to the transverse view.
The transverse scan consists of minimal vertical movements by the investigator who will obtain images using the ultrasound probe. The software will signal when the correct identification of the ligamentum flavum is visualized. The scan sequence will be completed.
The first phase will involve 20 non-obese patients who are undergoing neuraxial anaesthesia or analgesia. The system is used prior and during needle insertion to provide real-time guidance for the anaesthetists. The neuraxial needle insertion is conducted manually by the anaesthetist as per routine practice.
In the second phase, 50 obese patients (body mass index more than 30) will be recruited to investigate and develop an "obesity" mode visualisation of the ultrasound guided automated spinal landmark identification. This will be to advance the technology to evaluate more difficult anatomy and more complex neuraxial needle insertion in future work plan. The patients' back will be scanned to obtain the images. The neuraxial needle insertion is conducted manually (i.e. independent of the ultrasound results) by the anaesthetist as per hospital routine practice.
The third phase involve data collection and annotation of spinal ultrasonography in 65 obese patients, followed by a fourth phase to measure the uSINE identification accuracy and first-attempt puncture success rate in 65 obese patients.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ULTRA-SINE (phases 1-4) | Experimental | Procedure: Neuraxial ultrasonographyThere will be four phases in this proposed uSINE system. In first phase attending anaesthetist will use the automated spinal landmark system for neuraxial needle insertion to place the neuraxial anaesthesia in non-obese patients. For the second phase, obese patients will have ultrasound scan of their lumbar back and no needle insertion is involved. In third phase, conventional ultrasonography is used prior to the needle insertion, and needle insertion is conducted manually as per routine practice. The images collected in the system will be used for annotation and evaluation which serves as training material for uSINE to optimize its algorithm to improve landmark identification for obese patients. The fourth phase will have uSINE system used prior to the needle insertion, with the neuraxial needle insertion conducted manually as per routine practice. The identification accuracy and first-attempt puncture success rate of uSINE will be determined. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 21 - 75 years old patients who require neuraxial anesthesia for surgical procedure;
- Normal body mass index (Weight 40-90 kg, Height 140-180cm).
- Obese patients aged between 21-75 years old;
- body mass index more 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuraxial ultrasonographyUltrasound gel is applied to lower back lumbar spine of patient and placed with an ultrasound probe around the sacral region. The graphical interface of the software integrated with ultrasound machine will help identify the sacrum. The probe is moved in until the L3/4 interspinous space is identified for skin surface marking. Once the longitudinal scan is completed, the investigator will turn the probe 90° clockwise for transverse scan to identify ligamentum flavum. | Procedure or surgery | ULTRA-SINE (phases 1-4) |
Primary outcome
First attempt success rate of spinal anaesthesia
Time frame: 12 hours
The rate of cases achieving successful spinal anaesthesia at first attempt of insertion
3 secondary outcomes
Number of spinal attempts
Time frame: 12 hours
Time taken for ligamentum flavum identification
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 34663224In Chan JJ, Ma J, Leng Y, Tan KK, Tan CW, Sultana R, Sia ATH, Sng BL. Machine learning approach to needle insertion site identification for spinal anesthesia in obese patients. BMC Anesthesiol. 2021 Oct 18;21(1):246. doi: 10.1186/s12871-021-01466-8.
- Individual participant dataSharing planned: No
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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.
Ban L Sng, FANZCA principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuraxial ultrasonography in people with Spinal Anaesthesia and Obesity, run by KK Women's and Children's Hospital at 1 site in Singapore.
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 6 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: looking for participants now, 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.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Ban L Sng, FANZCA (+6563941081, sng.ban.leong@singhealth.com.sg), or a site near the patient. 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 NCT03687411, 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.