Clinical trial NCT03074487: Evaluating Monitoring Techniques for Postoperative Spinal Cord Ischemia
Official title: Exploratory Study Regarding the Use of Neurophysiological Monitoring Techniques to Detect Spinal Cord Ischemia in Patients After Thoracoabdominal Aortic Aneurysm Repair
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Monitoring
Postoperative
Spinal Cord Ischemia
Thoracoabdominal Aneurysm
TAAA
NIRS
Long Loop Reflexes
F-waves
Keywords: Spinal cord ischemia
Postoperative
Thoracoabdominal Aneurysm
Monitoring
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2017-03-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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).

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:

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


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

Primary outcomes:
measure: changes in MEP signals perioperative
timeFrame: 8 hours
measure: Presence of LLR (F-waves) perioperative
timeFrame: 8 hours
measure: Oxygenation of the paraspinal muscle tissue measured by NIRS perioperative
timeFrame: 8 hours
Secondary outcomes:
measure: The occurrence of intra- and postoperative changes in LLR (F-waves)
timeFrame: 24 hours
measure: The occurrence intra- and postoperative changesNIRS of the paraspinal muscle tissue
timeFrame: 24 hours
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: MaastrichtUMC
state: Limburg
Study officials:
References:
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citation: Moerman A, Van Herzeele I, Vanpeteghem C, Vermassen F, Francois K, Wouters P. Near-infrared spectroscopy for monitoring spinal cord ischemia during hybrid thoracoabdominal aortic aneurysm repair. J Endovasc Ther. 2011 Feb;18(1):91-5. doi: 10.1583/10-3224.1.
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