Neurophysiological Intraoperative Monitoring During Aortic Surgery

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02644681

Acronym

NIMAS

Enrollment

100

Registered

2016-01-01

Start date

2016-02-29

Completion date

2018-03-31

Last updated

2019-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Aneurysm, Thoracic

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.

Interventions

PROCEDUREAortic Aneurysm, Thoracic surgery

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* No

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026