Monitoring techniques for spinal cord health after surgery for thoracoabdominal aneurysms
Exploratory Study Regarding the Use of Neurophysiological Monitoring Techniques to Detect Spinal Cord Ischemia in Patients After Thoracoabdominal Aortic Aneurysm Repair
This study is testing if using special monitoring techniques during and after surgery for thoracoabdominal aneurysms can help protect the spinal cord and improve recovery for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Maastricht University Medical Center Academic / other |
| Locations | 1 site (Maastricht, Limburg) |
| Trial ID | NCT03074487 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of monitoring techniques, specifically motor evoked potentials (MEPs) and near-infrared spectroscopy, during and after surgery for thoracoabdominal aortic aneurysms (TAAA). The study aims to identify patients at risk for postoperative spinal cord ischemia, which can lead to delayed paraparesis. By assessing spinal cord function through MEPs during surgery and monitoring blood flow postoperatively, the research seeks to improve patient outcomes and reduce the incidence of complications. The study will include patients undergoing standard surgical procedures for TAAA who are monitored with MEPs.
Who should consider this trial
Good fit: Ideal candidates are patients with thoraco-abdominal aneurysms of the descending aorta who are undergoing surgical repair and are monitored with MEPs.
Not a fit: Patients with aneurysms only in the ascending part of the aorta or those who cannot provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of postoperative spinal cord ischemia and related complications in patients undergoing TAAA surgery.
How similar studies have performed: Previous studies have shown success in using MEPs for intraoperative monitoring, but the postoperative monitoring aspect is less explored, making this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Maastricht, Limburg
- MaastrichtUMC — Maastricht, Limburg, Netherlands (Recruiting)
Study contacts
- Study coordinator: Nadia A Sutedja, Dr
- Email: nadia.sutedja@mumc.nl
- Phone: +31 (0)43 387 4519,
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.