Development of an Ultrasound Guided Automated Spinal Landmark Identification System (uSINE Study)

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: Female
Minimum Age: 21
Maximum Age: 75
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
Singapore
KK Women's and Children's Hospital
RECRUITING
Singapore
Contact Information
Primary
Ban L Sng, FANZCA
sng.ban.leong@singhealth.com.sg
+6563941081
Backup
Alex T Sia, MMED
alex.sia.t.h@singhealth.com.sg
+6563941081
Time Frame
Start Date: 2018-05-24
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 200
Treatments
Experimental: ULTRA-SINE (phases 1-4)
There will be four phases in this proposed uSINE system. In first phase attending anaesthetist will use the automated spinal landmark system for neuraxial needle insertion to place the neuraxial anaesthesia in non-obese patients.~For the second phase, obese patients will have ultrasound scan of their lumbar back and no needle insertion is involved.~In third phase, conventional ultrasonography is used prior to the needle insertion, and needle insertion is conducted manually as per routine practice. The images collected in the system will be used for annotation and evaluation which serves as training material for uSINE to optimize its algorithm to improve landmark identification for obese patients. The fourth phase will have uSINE system used prior to the needle insertion, with the neuraxial needle insertion conducted manually as per routine practice. The identification accuracy and first-attempt puncture success rate of uSINE will be determined.
Related Therapeutic Areas
Sponsors
Leads: KK Women's and Children's Hospital

This content was sourced from clinicaltrials.gov