Neurophysiological Intraoperative Monitoring During Aortic Surgery (NIMAS)

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.

Study Overview

• Status: Completed
• Conditions: Aortic Aneurysm, Thoracic
• Intervention / Treatment: Procedure: Aortic Aneurysm, Thoracic surgery

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Italy
  • Milano, Italy, 20132
    • San Raffaele Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of all consecutive patients with thoracoabdominal aortic aneurysms who will be subjected to neuromonitoring-guided open repair of the aortic aneurysm at the Department of Vascular Surgery of San Raffaele Hospital.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• No exclusion criteria

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the motor-evoked potentials/motor action potential amplitude ratio	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.	During thoracoabdominal aortic aneurysms surgery

Collaborators and Investigators

• Sponsor: Scientific Institute San Raffaele

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: December 4, 2015
• First Submitted That Met QC Criteria: December 31, 2015
• First Posted (Estimate): January 1, 2016

Study Record Updates

• Last Update Posted (Actual): May 23, 2019
• Last Update Submitted That Met QC Criteria: May 21, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic
• Other Study ID Numbers: NIMAS/32/OSR