Obesity Clinical Trial
— uSINEOfficial 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).
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 31, 2023 |
Est. primary completion date | October 14, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 21 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Singapore | KK Women's and Children's Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
KK Women's and Children's Hospital |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | First attempt success rate of spinal anaesthesia | The rate of cases achieving successful spinal anaesthesia at first attempt of insertion | 12 hours | |
Secondary | Number of spinal attempts | The number of attempts to achieve successful spinal anaesthesia | 12 hours | |
Secondary | Time taken for ligamentum flavum identification | Time taken to identify the ligamentum flavum in the transverse view | 12 hours | |
Secondary | Distance from skin to ligamentum flavum | Distance from skin to ligamentum flavum as detected by the algorithm | 12 hours |
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