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OpenTrials
Completed

NCT Number: NCT02644681

Neurophysiological Intraoperative Monitoring During Aortic Surgery

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.

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Key information

Conditions

Aortic Aneurysm, Thoracic Aneurysm Aortic Aneurysm Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

San Raffaele Hospital

Milan, 20132, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • No exclusion criteria

Treatment and study plan

Aortic Aneurysm, Thoracic surgery

Procedure

Primary outcomes

  1. Evaluation of the motor-evoked potentials/motor action potential amplitude ratio

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Scientific Institute San Raffaele

Other

Registry information

Acronym: NIMAS

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 1, 2016
Registry last updated
May 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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