RecruitingNot ApplicableNCT03687411

An Ultrasound Guided Automated Spinal Landmark Identification System

Development of an Ultrasound Guided Automated Spinal Landmark Identification System (uSINE Study)


Sponsor

KK Women's and Children's Hospital

Enrollment

200 participants

Start Date

May 24, 2018

Study Type

INTERVENTIONAL

Conditions

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, 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).


Eligibility

Sex: FEMALEMin Age: 21 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study develops and tests a new ultrasound-guided computer system (uSINE) designed to automatically identify spinal landmarks and help anesthesiologists place needles more accurately for spinal anesthesia or lumbar punctures — procedures that currently rely on feel alone, which can lead to multiple attempts, especially in people with higher body weight. The system uses ultrasound imaging in real time to guide needle placement at the correct spinal level. Adults aged 21–75 who need spinal anesthesia for a surgical procedure are eligible for the initial phase (normal BMI); subsequent phases recruit adults with a BMI over 30. Participation involves having the ultrasound system used on the lower back before and during the standard needle placement procedure, with no extra injections required beyond routine anesthesia care. This summary was generated with AI assistance and is intended to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURENeuraxial ultrasonography

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.


Locations(1)

KK Women's and Children's Hospital

Singapore, Singapore

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NCT03687411


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