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NCT Number: NCT03074487

Evaluating Monitoring Techniques for Postoperative Spinal Cord Ischemia

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).

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Key information

Conditions

Monitoring Cardiovascular Diseases Central Nervous System Diseases F-waves Long Loop Reflexes NIRS Nervous System Diseases Postoperative Spinal Cord Diseases Spinal Cord Ischemia Spinal Cord Vascular Diseases TAAA Thoracoabdominal Aneurysm Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

MaastrichtUMC

Maastricht, Limburg, Netherlands

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Near-infrared spectroscopy

Device

Other names: NIRS

Long loop reflex measurements

Device

Other names: F-waves

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Acronym: SINATRA

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Mar 8, 2017
Registry last updated
Oct 1, 2025

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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