Actively Recruiting

Phase Not Applicable
Age: 21Years - 75Years
FEMALE
NCT03687411

An Ultrasound Guided Automated Spinal Landmark Identification System

Led by KK Women's and Children's Hospital · Updated on 2024-10-09

200

Participants Needed

1

Research Sites

501 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

An Ultrasound Guided Automated Spinal Landmark Identification System

Who Can Participate

Age: 21Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 21 to 75 years old patients who require neuraxial anesthesia for surgical procedure
  • Normal body mass index (Weight 40-90 kg, Height 140-180 cm) for first phase
  • Obese patients aged 21 to 75 years old with body mass index more than 30 for second to fourth phases
Not Eligible

You will not qualify if you...

  • History of scoliosis
  • History of spinal instrumentation
  • Allergy to ultrasound gel
  • Visible wound or injury in the lumbar spine

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

CONTACT

A

Alex T Sia, MMED

CONTACT

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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