About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
History of scoliosis;
History of spinal instrumentation;
Drug allergy to ultrasound transmission gel;
Visible wound or injury in the lumbar spine.
Trial design
Single group
Treatments tested in this trial
Neuraxial ultrasonography
Procedure/SurgeryUltrasound 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.
Treatment groups
Trial outcomes
Primary outcomes
First attempt success rate of spinal anaesthesia
The rate of cases achieving successful spinal anaesthesia at first attempt of insertion
Secondary outcomes
Number of spinal attempts
The number of attempts to achieve successful spinal anaesthesia
Time taken for ligamentum flavum identification
Time taken to identify the ligamentum flavum in the transverse view
Distance from skin to ligamentum flavum
Distance from skin to ligamentum flavum as detected by the algorithm
Sponsors and contacts
Click on the lead sponsor to view all of their trials.