Clinical trial

An Ultrasound Guided Automated Spinal Landmark Identification System

Recruiting now · Not applicable · 1 countries · Registry ID NCT03687411

Recruiting nowNot applicableInterventional

What this study is about

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).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age21 Years to 75 Years

SexFemale

Healthy volunteersNot accepted

ConditionSpinal Anaesthesia, Obesity

Full registry criteria

Inclusion Criteria: 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. Exclusion Criteria: * History of scoliosis; * History of spinal instrumentation; * Drug allergy to ultrasound transmission gel; * Visible wound or injury in the lumbar spine.

Treatments and study arms

Neuraxial ultrasonography

Procedure

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.

Primary outcomes

First attempt success rate of spinal anaesthesia12 hours

The rate of cases achieving successful spinal anaesthesia at first attempt of insertion

Study locations

1 locations were listed when this page was built. The first 40 are shown.

KK Women's and Children's Hospital🇸🇬 Singapore, Singapore

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Ban Leong Sng, MBBS, MMEDContact

Email · Call +6563941081