Neurophysiological Intraoperative Monitoring During Aortic Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Aneurysm, Thoracic
- Sponsor
- Scientific Institute San Raffaele
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Evaluation of the motor-evoked potentials/motor action potential amplitude ratio
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Chiesa Roberto
Professor
Scientific Institute San Raffaele
Eligibility Criteria
Inclusion Criteria
- •satisfied criteria for Intraoperative neurophysiological monitoring;
- •sign a written informed consent to participate in the study.
Exclusion Criteria
- •No exclusion criteria
Outcomes
Primary Outcomes
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.