Evaluating Monitoring Techniques for Postoperative Spinal Cord Ischemia (SINATRA)

March 18, 2024 updated by: Maastricht University Medical Center

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

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:

  1. Long loop reflexes (LLR) consisting of F-waves.
  2. Oxygenation measurements of the paraspinal muscles using Near-infrared spectroscopy (NIRS).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands
        • Recruiting
        • MaastrichtUMC
        • Contact:
        • Principal Investigator:
          • Nadia A Sutedja, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing a thoraco-abdominal aortic aneurysm (TAAA) repair by either open surgical or endovascular procedures are eligible for inclusion. The study population will include patients undergoing TAAA repair in Maastricht (Netherlands), Aachen (Germany) and Bern, (Switzerland).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in MEP signals perioperative
Time Frame: 8 hours
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
Time Frame: 8 hours
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
Time Frame: 8 hours
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)
Time Frame: 24 hours
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
Time Frame: 24 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

February 21, 2017

First Submitted That Met QC Criteria

March 3, 2017

First Posted (Actual)

March 8, 2017

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL58137.068.16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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