跳至主要内容
临床试验/CTRI/2026/02/104854
CTRI/2026/02/104854尚未招募不适用

Accuracy of Epidural Pressure Waveform Analysis for Determining the Correct Placement of Epidural Catheter in Elderly Patients-An Observational Analytical Study

Jawaharlal Institute of Postgraduate Medical Education and Research1 个研究点 分布在 1 个国家目标入组 193 人开始时间: 2026年3月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
193
试验地点
1

研究概览

简要总结

This observational analytical study evaluates the diagnostic accuracy of Epidural Pressure Waveform Analysis using an arterial pressure transducer for confirming the correct placement of an epidural catheter in elderly patients of age 60 years and above undergoing surgery. The study is designed to compare the Epidural Pressure Waveform Analysis method against the dermatomal testing of cold sensation. A total of 193 elderly patients will be enrolled in the study. The design employs blinding, where one anesthesiologist performs the cold sponge test and a second anesthesiologist, blinded to the results of the cold test, performs the waveform analysis. The primary outcome is to determine the sensitivity and specificity of epidural waveform analysis in identifying correct catheter placement. Secondary outcomes include finding the positive predictive value and negative predictive value, evaluating the accuracy with respect to thoracic and lumbar epidural placement, determining the amount of saline required to obtain the epidural pressure waveforms, measuring the number of epidural revision rates, and finding the association between mean arterial pressure, plethysmographic variability index, and the presence or absence of the epidural waveform. The study aims to determine if the cost-effective and objective Epidural Pressure Waveform Analysis method is a reliable diagnostic tool for confirming epidural catheter placement in the elderly population, where existing literature on this method is lacking for this age group.

研究设计

研究类型
Observational

入排标准

年龄范围
60.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients of age 60 years and above undergoing surgeries anticipated to have epidural anaesthesia or analgesia through epidural catheter.
  • 2.American Society of Anaesthesiologists (ASA) physical status I -III.

排除标准

  • 1.Patients with hemodynamic instability 2.Coagulation disorders 3.Local site infection 4.Hypersensitivity to local anaesthetics 5.Plan for real time, USG guided epidural placement 6.Contraindication to adrenaline containing epidural test dose.

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Afnan Rimzy P

Jawaharlal Institute of Postgraduate Medical Education and Research

研究点 (1)

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