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NIRS MONITORING OF SPINAL CORD ISCHEMIA IN AORTIC SURGERY

Recruitingn/aAges 18 Years - anyAllMonaldi Hospital
NCT07541612 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This prospective observational study aims to evaluate the feasibility and clinical utility of near-infrared spectroscopy (NIRS) monitoring applied to paraspinal muscles as a surrogate marker of spinal cord perfusion in patients undergoing major noncardiac surgery. Spinal cord ischemia represents a rare but devastating complication, often difficult to detect in real time. NIRS provides a non-invasive, continuous monitoring of regional tissue oxygen saturation (rSO₂), potentially reflecting microcirculatory changes in paraspinal tissues and indirectly spinal cord perfusion. The study will enroll adult patients undergoing major surgery requiring advanced hemodynamic monitoring. NIRS sensors will be placed over paraspinal regions, and rSO₂ values will be continuously recorded throughout the perioperative period. Hemodynamic parameters, including arterial pressure, cardiac output, and other

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📋 Eligibility rules (as published)
Inclusion Criteria: Adult patients aged 18 years or older Patients scheduled for elective thoracic or thoracoabdominal aortic repair, including open, endovascular (TEVAR/FEVAR), or hybrid procedures Patients undergoing intraoperative paraspinal near-infrared spectroscopy (NIRS) monitoring Written informed consent obtained before enrollment Exclusion Criteria: Age under 18 years Emergency surgical procedures Pregnancy Pre-existing paraplegia or severe neurological impairment Skin lesions or conditions preventing correct placement of NIRS sensors Refusal or inability to provide informed consent
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What it tests

  • Near-Infrared Spectroscopy (NIRS)
  • Cerebrospinal fluid drainage via lumbar catheter (L3-L4) to maintain cerebrospinal fluid pressure below target levels and optimize spinal cord perfusion pressure during aortic surgery.
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Where

1 site
AORN Ospedali dei Colli - Monaldi Hospital
Naples, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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