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Trial record 15 of 100 for:    "thoracic aortic aneurysms and aortic dissections" OR "Aortic Aneurysm, Thoracic"

Neurophysiological Intraoperative Monitoring During Aortic Surgery (NIMAS)

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ClinicalTrials.gov Identifier: NCT02644681
Recruitment Status : Completed
First Posted : January 1, 2016
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Chiesa Roberto, Scientific Institute San Raffaele

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
Aortic Aneurysm, Thoracic Procedure: Aortic Aneurysm, Thoracic surgery

Study Type : Observational [Patient Registry]
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Neurophysiological Intraoperative Monitoring During Aortic Surgery
Study Start Date : February 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • No exclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02644681


Locations
Italy
San Raffaele Hospital
Milano, Italy, 20132
Sponsors and Collaborators
Scientific Institute San Raffaele

Responsible Party: Chiesa Roberto, Professor, Scientific Institute San Raffaele
ClinicalTrials.gov Identifier: NCT02644681     History of Changes
Other Study ID Numbers: NIMAS/32/OSR
First Posted: January 1, 2016    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases