跳至主要内容
临床试验/NCT03535155
NCT03535155进行中(未招募)不适用

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

KK Women's and Children's Hospital0 个研究点目标入组 100 人开始时间: 2016年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
100
主要终点
First attempt success rate of spinal anaesthesia

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
21 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • History of scoliosis;
  • History of spinal instrumentation;
  • Drug allergy to ultrasound transmission gel;
  • Visible wound or injury in the lumbar spine.

结局指标

主要结局

First attempt success rate of spinal anaesthesia

时间窗: 12 hours

First attempt success rate of spinal anaesthesia

次要结局

  • Number of spinal attempts(12 hours)
  • Distance from skin to ligamentum flavum(12 hours)
  • Time taken to identify the ligamentum flavum in the transverse view(12 hours)

研究者

发起方
KK Women's and Children's Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Sng Ban Leong

Principal Investigator

KK Women's and Children's Hospital

相似试验