Clinical Trial: Neurophysiological Intraoperative Monitoring During Aortic Surgery
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]
Official Title: Neurophysiological Intraoperative Monitoring During Aortic Surgery
Brief Summary:
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.
Detailed Summary:
Sponsor: Scientific Institute San Raffaele
Current Primary Outcome: Evaluation of the motor-evoked potentials/motor action potential amplitude ratio [ Time Frame: 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.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Scientific Institute San Raffaele
Dates:
Date Received: December 4, 2015
Date Started: February 2016
Date Completion: June 2017
Last Updated: April 28, 2017
Last Verified: April 2017
