Evaluating Monitoring Techniques for Postoperative Spinal Cord Ischemia (SINATRA)

Maastricht University Medical Centre (MUMC) logo

Maastricht University Medical Centre (MUMC)

Status

Enrolling

Conditions

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

Treatments

Device: Long loop reflex measurements
Device: Near-infrared spectroscopy

Study type

Observational

Funder types

Other

Identifiers

NCT03074487
NL58137.068.16

Details and patient eligibility

About

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).

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

0

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Central trial contact

Nadia A Sutedja, Dr

Data sourced from clinicaltrials.gov

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