Neurophysiological Intraoperative Monitoring During Aortic Surgery (NIMAS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02644681|
Recruitment Status : Completed
First Posted : January 1, 2016
Last Update Posted : May 23, 2019
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.
|Condition or disease||Intervention/treatment|
|Aortic Aneurysm, Thoracic||Procedure: Aortic Aneurysm, Thoracic surgery|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||100 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Neurophysiological Intraoperative Monitoring During Aortic Surgery|
|Study Start Date :||February 2016|
|Actual Primary Completion Date :||March 2018|
|Actual Study Completion Date :||March 2018|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02644681
|San Raffaele Hospital|
|Milano, Italy, 20132|