Neurophysiological Intraoperative Monitoring During Aortic Surgery

NCT02644681 | Completed

• 1 other identifier: NIMAS/32/OSR
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Aneurysm, Thoracic

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Aortic Aneurysm, Thoracic surgery PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Scientific Institute San Raffaele: lead

Study Sites (1)

San Raffaele Hospital

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic

Interventions

Thoracic Surgical Procedures

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 4, 2015
• First Posted: January 1, 2016
• Study Start: February 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: May 23, 2019

Record last verified: 2019-05

Locations

IT (1)