Machine learning approach to needle insertion site identification for spinal anesthesia in obese patients.
Jason Ju In Chan, Jun Ma, Yusong Leng...
https://pubmed.ncbi.nlm.nih.gov/34663224Actively Recruiting
Phase Not Applicable
Age: 21Years - 75Years
FEMALE
ID03687411
Development of an Ultrasound Guided Automated Spinal Landmark Identification System (uSINE Study)
Led by KK Women's and Children's Hospital · Updated on 2024-10-09
200
Participants Needed
1
Research Sites
63 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an ultrasound-guided automated spinal landmark identification system called uSINE to improve the safety and success of neuraxial needle insertion for spinal anesthesia. This study focuses on patients requiring spinal anesthesia, including both non-obese and obese individuals, addressing challenges in the traditional landmark palpation technique which can lead to multiple needle insertion attempts and higher risks of complications. The research is conducted in four phases involving technology development and clinical trials to improve accuracy and first-attempt success rates. The study involves applying ultrasound gel to the lower back and using a wireless ultrasound probe to identify spinal landmarks such as the sacrum, L3/4 interspinous space, and ligamentum flavum in real time. In the first phase, the system guides needle insertion in 20 non-obese patients. The second phase scans 50 obese patients to develop an obesity-specific visualization mode without needle insertion. The third phase collects and annotates ultrasound images from 65 obese patients, and the fourth phase assesses the uSINE system's accuracy and first-attempt needle success in another 65 obese patients, with manual needle insertion throughout. Participants will have their lower back scanned with ultrasound while seated, with software guiding the identification of spinal landmarks. The investigators will record outcomes such as the first attempt success rate of spinal anesthesia, number of needle attempts, time to identify ligamentum flavum, and skin-to-ligamentum flavum distance, all monitored within 12 hours post-procedure. The study includes detailed ultrasound imaging, software analysis, and manual needle insertion by anesthetists following routine practice. The total participation timeline varies by study phase and patient group, focusing on improving spinal anesthesia procedures.
CONDITIONS
Brief Title
An Ultrasound Guided Automated Spinal Landmark Identification System
Who Can Participate
Age: 21Years - 75Years
FEMALE
Eligibility Criteria
You may qualify if you...
- For phase one: Patients aged 21 to 75 years who need neuraxial anesthesia for surgery
- Patients with normal body mass index (weight 40-90 kg, height 140-180 cm)
- For phases two to four: Obese patients aged 21 to 75 years
- Body mass index over 30
You will not qualify if you...
- History of scoliosis
- History of spinal instrumentation
- Allergy to ultrasound transmission gel
- Visible wound or injury on the lumbar spine
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Ultrasound Guided Spinal Landmark Identification
Duration - Day of procedure
Participants undergo ultrasound scanning of the lower back lumbar spine to identify spinal landmarks using an automated system before or during neuraxial needle insertion depending on the study phase.
1 visit (in-person)
Neuraxial Needle Insertion
Duration - Day of procedure
For applicable phases, participants receive manual neuraxial needle insertion guided by ultrasound or conventional methods as per routine practice.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
KK Women's and Children's Hospital
Singapore, Singapore, 229899
Actively Recruiting
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Research Team
B
Ban L Sng, FANZCA
A
Alex T Sia, MMED
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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