NCT03687411: uSINE

An Ultrasound Guided Automated Spinal Landmark Identification System

Recruiting now NA Last updated 9 October 2024

What this trial tests

NA trial testing Neuraxial ultrasonography in Spinal Anaesthesia in 200 participants. Currently enrolling.

Timeline

24 May 2018

Primary endpoint
14 October 2026

31 December 2027

Quick facts

Lead sponsor	KK Women's and Children's Hospital
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	200
Start date	24 May 2018
Primary completion	14 October 2026
Estimated completion	31 December 2027
Sites	1 location across Singapore

Drugs / interventions tested

• Neuraxial ultrasonography

Conditions studied

• Spinal Anaesthesia — all drugs for Spinal Anaesthesia →
• Obesity — all drugs for Obesity →

Sponsor

KK Women's and Children's Hospital

Who can join

Adults 21 to 75, female only, with Spinal Anaesthesia or Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Machine learning approach to needle insertion site identification for spinal anesthesia in obese patients.
   In Chan JJ, Ma J, Leng Y, Tan KK, et al · · 2021 · cited 15× · PMID 34663224 · DOI 10.1186/s12871-021-01466-8