Neurophysiological Intraoperative Monitoring During Aortic Surgery

Completed

• Conditions: Aortic Aneurysm, Thoracic

• Registration Number: NCT02644681
• Lead Sponsor: Scientific Institute San Raffaele

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 Description

Not available

Study Timeline

• Study First Submitted: 2015-12-04
• Study First Submitted QC: 2015-12-31
• Study First Posted: 2016-01-01
• Study Start: 2016-02
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-21
• Last Update Posted: 2019-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• No exclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the motor-evoked potentials/motor action potential amplitude ratio	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.

Trial Locations

Locations (1)

San Raffaele Hospital; 🇮🇹 Milano, Italy