Evaluating Monitoring Techniques for Postoperative Spinal Cord Ischemia

Study Overview
=================
Brief Summary
-----------------
During open surgery of a thoraco-abdominal aortic aneurysma (TAAA), diminished blood flow to the myelum can result in hypoxia, compromising proper function of the spinal cord. Intraoperatively, motor evoked potentials (MEP) are elicited to measure the functional integrity of the spinal cord. MEPs have proven to be a reliable marker of spinal cord ischemia. Moreover, these potentials react within minutes, which facilitates interventions to restore the blood flow. Monitoring intraoperatively with this ancillary test has reduced the rate of paraparesis to < 5%. Unfortunately, in the early postoperative period, spinal cord vulnerability is high. Therefore, some patients develop paraparesis, not during the surgical procedure, but after the surgical procedure. Postoperatively, suboptimal blood flow may lead to critical loss of function. This inadequate perfusion results in delayed paraparesis. In the postoperative patient, it is not possible to measure MEPs when sedation is decreased, due to the high intensity of the electrical stimulus, which is unacceptably painful in the unanesthetized or partially anesthetized patient. Therefore ancillary tests are needed which can detect spinal cord ischemia postoperatively early, thus preceding the phase with clinically overt paraparesis. The test should be reliable and easy to perform for an extended period of time (up to several days). The purpose of this study is to explore the usefulness of various neurophysiological tests regarding accuracy and feasibility for the detection of spinal cord ischemia. In particular, to find a diagnostic test which is acceptable for the unanesthetized or partially anesthetized patient and therefore can also be performed postoperatively. These tests will be examined in fully sedated as well as partially sedated patients. The following candidate tests will be examined: Long loop reflexes (LLR) consisting of F-waves. Oxygenation measurements of the paraspinal muscles using Near-infrared spectroscopy (NIRS).

Official Title
-----------------
Exploratory Study Regarding the Use of Neurophysiological Monitoring Techniques to Detect Spinal Cord Ischemia in Patients After Thoracoabdominal Aortic Aneurysm Repair

Conditions
-----------------
Monitoring, Postoperative, Spinal Cord Ischemia, Thoracoabdominal Aneurysm, TAAA, NIRS, Long Loop Reflexes, F-waves

Intervention / Treatment
-----------------
* Device: Near-infrared spectroscopy
* Device: Long loop reflex measurements


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Thoraco-abdominal aneurysm (TAA) of the descending aorta: Crawford type I,II, III, IV or V Repair using open surgical or endovascular procedure. Undergoing monitoring by motor evoked potentials (MEP) as part of the standard surgical procedure. Exclusion Criteria: Aneurysm only in ascending part of the aorta Standard contraindications for motor evoked potential (MEP) monitoring. Standard contraindications for electrode placement (skin wounds, etc.) No informed consent can be obtained prior to the procedure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Near-infrared spectroscopy|nan|
|Device: Long loop reflex measurements|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in MEP signals perioperative | These signals will be recoded into categorical variables. To determine associations logistic regression analysis will be performed (univariate and multivariate adjusting for confounders). Screening test calculations (sensitivity, specificity, positive and negative predictive values, false-positive and false-negative rates) will be performed using standard contingency table methods. Agreement between the methods (vs MEP) will be estimated using the Cohen k statistic. The results will first be evaluated descriptively to fine-tune the cut-off values in de the definitive protocol. | 8 hours | 
| Presence of LLR (F-waves) perioperative | These signals will be recoded into categorical variables. To determine associations logistic regression analysis will be performed (univariate and multivariate adjusting for confounders). Screening test calculations (sensitivity, specificity, positive and negative predictive values, false-positive and false-negative rates) will be performed using standard contingency table methods. Agreement between the methods (vs MEP) will be estimated using the Cohen k statistic. The results will first be evaluated descriptively to fine-tune the cut-off values in de the definitive protocol. | 8 hours | 
| Oxygenation of the paraspinal muscle tissue measured by NIRS perioperative | These signals will be recoded into categorical variables. To determine associations logistic regression analysis will be performed (univariate and multivariate adjusting for confounders). Screening test calculations (sensitivity, specificity, positive and negative predictive values, false-positive and false-negative rates) will be performed using standard contingency table methods. Agreement between the methods (vs MEP) will be estimated using the Cohen k statistic. The results will first be evaluated descriptively to fine-tune the cut-off values in de the definitive protocol. | 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of intra- and postoperative changes in LLR (F-waves) | These signals will be recoded into categorical variables. To determine associations logistic regression analysis will be performed (univariate and multivariate adjusting for confounders). Screening test calculations (sensitivity, specificity, positive and negative predictive values, false-positive and false-negative rates) will be performed using standard contingency table methods. The results will first be evaluated descriptively to fine-tune the cut-off values in de the definitive protocol. | 24 hours | 
| The occurrence intra- and postoperative changesNIRS of the paraspinal muscle tissue | These signals will be recoded into categorical variables. To determine associations logistic regression analysis will be performed (univariate and multivariate adjusting for confounders). Screening test calculations (sensitivity, specificity, positive and negative predictive values, false-positive and false-negative rates) will be performed using standard contingency table methods. The results will first be evaluated descriptively to fine-tune the cut-off values in de the definitive protocol. | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal cord ischemia, Postoperative, Thoracoabdominal Aneurysm, Monitoring