Ultrasound Identification Automation Study

Spinal Anesthesia Clinical Trial

Official title:

Automated Spinal Landmark Identification to Improve Patient Safety and Efficacy During Neuraxial Anaesthesia Needle Insertion

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03535155
• Other study ID #: SHF-NHIC/MT006/2015
• Status: Active, not recruiting
• Start date: May 1, 2016
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: KK Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The overall aim of this study is to develop an automated spinal landmark identification system to improve patient safety and efficacy of neuraxial procedure needle insertion success. This is a prospective cohort study to evaluate the accuracy of the automated spinal landmark identification technique using image processing system based on identification by experienced investigator using ultrasound in subjects requiring spinal anesthesia.

Description:

Neuraxial procedures are commonly performed with wide range of therapeutic and diagnostic indications. Applications include neuraxial anesthesia for surgery, epidural labour analgesia, epidural steroid injections and lumbar punctures. 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. A key challenge for neuraxial procedures is the correct identification of needle insertion site. The ultrasound imaging technique has found its way to neuraxial procedures as an imaging method to detect the inner anatomical structure of the lumbar spine and is superior to the traditional palpation method. However, a full interpretation of ultrasound images requires professional training and experience. The overall aim of this proposal is to develop an automated spinal landmark identification system to improve patient safety and efficacy of neuraxial procedure needle insertion success. The primary aim is to develop an automated spinal landmark identification algorithm using image processing system to achieve 90% 1st spinal needle success rate within 12 months. The investigators will recruit 100 subjects in a prospective cohort study to investigate the spinal needle success rate as a clinically relevant outcome.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age between 21-75 years old who required spinal anesthesia for surgical procedure;
• Weight of 40-90kg and height of 140-180cm;
• BMI less 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.

Related Conditions & MeSH terms

• Spinal Anesthesia

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital	National University of Singapore

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First attempt success rate of spinal anaesthesia	First attempt success rate of spinal anaesthesia	12 hours
Secondary	Number of spinal attempts	The number of attempts to achieve successful spinal anaesthesia	12 hours
Secondary	Time taken to identify the ligamentum flavum in the transverse view	Time taken to identify the ligamentum flavum in the transverse view	12 hours
Secondary	Distance from skin to ligamentum flavum	Distance from skin to ligamentum flavum	12 hours