Automated ultrasound system for spinal landmark identification
Development of an Ultrasound Guided Automated Spinal Landmark Identification System (uSINE Study)
This study is testing a new ultrasound system to help doctors find the right spots on the spine for needle insertion, aiming to make the process safer and more accurate for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 21 Years to 75 Years |
| Sex | Female |
| Sponsor | KK Women's and Children's Hospital Government |
| Locations | 1 site (Singapore) |
| Trial ID | NCT03687411 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and evaluate an ultrasound guided automated spinal landmark identification system (uSINE) to enhance the accuracy and safety of neuraxial needle insertion. The approach involves using real-time ultrasound imaging to identify spinal landmarks, which is expected to reduce the number of failed attempts and complications associated with traditional palpation techniques. The study will recruit 20 subjects, including both non-obese and obese patients, to assess the efficacy of this innovative technology in a prospective cohort design. The system will provide guidance to anesthetists during the procedure, potentially improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients aged 21-75 requiring neuraxial anesthesia, with specific inclusion criteria based on body mass index.
Not a fit: Patients with a history of scoliosis, spinal instrumentation, or drug allergies to ultrasound gel may not benefit from this study.
Why it matters
Potential benefit: If successful, this system could significantly improve the success rate of neuraxial procedures and reduce patient discomfort and complications.
How similar studies have performed: Previous studies have shown the effectiveness of ultrasound imaging in improving spinal anesthesia techniques, but this specific automated approach is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Singapore
- KK Women's and Children's Hospital — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Ban L Sng, FANZCA — KK Women's and Children's Hospital
- Study coordinator: Ban L Sng, FANZCA
- Email: sng.ban.leong@singhealth.com.sg
- Phone: +6563941081
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.