跳至主要内容
临床试验/NCT02644681
NCT02644681已完成不适用

Neurophysiological Intraoperative Monitoring During Aortic Surgery

Scientific Institute San Raffaele1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Evaluation of the motor-evoked potentials/motor action potential amplitude ratio

研究概览

简要总结

The primary objective of this study is to evaluate if the motor-evoked potentials/motor action potential amplitude ratio and motor action potential amplitude measurement are useful in detecting spinal cord ischemia during thoracoabdominal aortic aneurysms surgery.

The secondary objective is to evaluate the presence of a correlation between neurophysiological changes and other factors (such as surgical maneuvers, anesthetic and physiologic changes) in order to find which factor is the most important in determining spinal cord ischemia.

This study is an observational, single-center, prospective study on patients with thoracoabdominal aortic aneurysms undergoing surgical repair with intraoperative motor-evoked potentials and somatosensory evoked potentials monitoring.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • satisfied criteria for Intraoperative neurophysiological monitoring;
  • sign a written informed consent to participate in the study.

排除标准

  • No exclusion criteria

结局指标

主要结局

Evaluation of the motor-evoked potentials/motor action potential amplitude ratio

时间窗: During thoracoabdominal aortic aneurysms surgery

The goal of this study is to evaluate the efficacy of different neurophysiological parameters in predicting patient outcome. In particular, our objective is to verify if a better identification of peripheral nerve ischemia during TAAA procedure can improve the sensibility of Intraoperative neurophysiological monitoring in detecting spinal cord ischemia and predicting clinical outcome. Exploratory univariate analyses will be performed using logistic regression to calculate odds ratios to evaluate neurophysiological parameters associated with poor outcome. Factors that will be found to be significant at p \< 0.05 will be then examined in subsequent multivariate analyses to determine significant independent predictors of poor outcome.

次要结局

未报告次要终点

研究者

发起方
Scientific Institute San Raffaele
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chiesa Roberto

Professor

Scientific Institute San Raffaele

研究点 (1)

Loading locations...

相似试验