Evaluating Monitoring Techniques for Postoperative Spinal Cord Ischemia

NCT03074487 | Completed

• 1 other identifier: NL58137.068.16
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Spinal cord ischemia; Postoperative; Thoracoabdominal Aneurysm; Monitoring

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• The occurrence of intra- and postoperative changes in LLR (F-waves)

  24 hours

• The occurrence intra- and postoperative changesNIRS of the paraspinal muscle tissue

  24 hours

Interventions

Near-infrared spectroscopy DEVICE

Also known as: NIRS

Long loop reflex measurements DEVICE

Also known as: F-waves

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

MaastrichtUMC

Maastricht, Limburg, Netherlands

Location

Related Publications (8)

• Jacobs MJ, Mess W, Mochtar B, Nijenhuis RJ, Statius van Eps RG, Schurink GW. The value of motor evoked potentials in reducing paraplegia during thoracoabdominal aneurysm repair. J Vasc Surg. 2006 Feb;43(2):239-46. doi: 10.1016/j.jvs.2005.09.042.

  PMID: 16476594 BACKGROUND

• Greiner A, Mess WH, Schmidli J, Debus ES, Grommes J, Dick F, Jacobs MJ. Cyber medicine enables remote neuromonitoring during aortic surgery. J Vasc Surg. 2012 May;55(5):1227-32; discussion 1232-3. doi: 10.1016/j.jvs.2011.11.121. Epub 2012 Feb 15.

  PMID: 22341581 BACKGROUND

• Armstrong KL, Wood D. Can infant death from child abuse be prevented? Med J Aust. 1992 Feb 17;156(4):290. doi: 10.5694/j.1326-5377.1992.tb139757.x. No abstract available.

  PMID: 1738333 BACKGROUND

• Etz CD, Di Luozzo G, Zoli S, Lazala R, Plestis KA, Bodian CA, Griepp RB. Direct spinal cord perfusion pressure monitoring in extensive distal aortic aneurysm repair. Ann Thorac Surg. 2009 Jun;87(6):1764-73; discussion 1773-4. doi: 10.1016/j.athoracsur.2009.02.101.

  PMID: 19463592 BACKGROUND

• Jacobs MJ, Mess WH. The role of evoked potential monitoring in operative management of type I and type II thoracoabdominal aortic aneurysms. Semin Thorac Cardiovasc Surg. 2003 Oct;15(4):353-64. doi: 10.1053/s1043-0679(03)00084-4.

  PMID: 14710377 BACKGROUND

• Etz CD, von Aspern K, Gudehus S, Luehr M, Girrbach FF, Ender J, Borger M, Mohr FW. Near-infrared spectroscopy monitoring of the collateral network prior to, during, and after thoracoabdominal aortic repair: a pilot study. Eur J Vasc Endovasc Surg. 2013 Dec;46(6):651-6. doi: 10.1016/j.ejvs.2013.08.018. Epub 2013 Sep 5.

  PMID: 24099957 BACKGROUND

• 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.

  PMID: 21314355 BACKGROUND

• Boezeman RP, van Dongen EP, Morshuis WJ, Sonker U, Boezeman EH, Waanders FG, de Vries JP. Spinal near-infrared spectroscopy measurements during and after thoracoabdominal aortic aneurysm repair: a pilot study. Ann Thorac Surg. 2015 Apr;99(4):1267-74. doi: 10.1016/j.athoracsur.2014.10.032. Epub 2015 Jan 14.

  PMID: 25596871 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Ischemia

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Spinal Cord Vascular Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: March 8, 2017
• Study Start: January 1, 2017
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-05

Locations

NL (1)