NIMAS: Neurophysiological Intraoperative Monitoring During Aortic Surgery

• Sponsor: Scientific Institute San Raffaele (Other)
• Overall Status: Completed
• CT.gov ID: NCT02644681
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Duration (Months): 24.9
• Patients Per Site Per Month: 4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Aneurysm, Thoracic	Procedure: Aortic Aneurysm, Thoracic surgery

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Neurophysiological Intraoperative Monitoring During Aortic Surgery
• Study Start Date: Feb 1, 2016
• Actual Primary Completion Date: Mar 1, 2018
• Actual Study Completion Date: Mar 1, 2018

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• satisfied criteria for Intraoperative neurophysiological monitoring;

• sign a written informed consent to participate in the study.

Exclusion Criteria:

• No exclusion criteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Raffaele Hospital	Milano		Italy	20132

Sponsors and Collaborators

• Scientific Institute San Raffaele

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chiesa Roberto, Professor, Scientific Institute San Raffaele
• ClinicalTrials.gov Identifier: NCT02644681
• Other Study ID Numbers: NIMAS/32/OSR
• First Posted: Jan 1, 2016
• Last Update Posted: May 23, 2019
• Last Verified: May 1, 2019

• Additional relevant MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic

Study Results

No Results Posted as of May 23, 2019