RecruitingNCT07541612

NIRS MONITORING OF SPINAL CORD ISCHEMIA IN AORTIC SURGERY

MONITORING AND PREVENTION OF SPINAL CORD iSCHEMIA IN AORTIC SURGERY USING PARASPINAL NEAR-INFRARED SPECTROSCOPY (NIRS)


Sponsor

Monaldi Hospital

Enrollment

120 participants

Start Date

Aug 23, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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 relevant clinical variables, will be simultaneously collected. The primary objective is to assess changes in paraspinal rSO₂ during perioperative management and their relationship with systemic hemodynamic variables. Secondary objectives include the evaluation of the association between rSO₂ variations and postoperative neurological outcomes, as well as the feasibility and reliability of this monitoring technique in routine clinical practice. This study may provide preliminary evidence supporting the use of NIRS as a bedside, non-invasive tool for early detection of impaired spinal cord perfusion and for guiding hemodynamic optimization strategies.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • 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 Criteria1

  • 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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Interventions

DIAGNOSTIC_TESTNear-Infrared Spectroscopy (NIRS)

Paraspinal sensors are applied bilaterally at thoracic-lumbar levels (approximately T8-L2) to continuously monitor regional oxygen saturation (rSO2). Data are recorded intraoperatively and during the early postoperative period (up to 72 hours), allowing detection of changes potentially associated with spinal cord hypoperfusion.

PROCEDURECerebrospinal fluid drainage via lumbar catheter (L3-L4) to maintain cerebrospinal fluid pressure below target levels and optimize spinal cord perfusion pressure during aortic surgery.

A lumbar cerebrospinal fluid drainage catheter is inserted (typically at L3-L4) and managed to maintain cerebrospinal fluid pressure below 10 mmHg, with the aim of optimizing spinal cord perfusion pressure (SCPP ≥75 mmHg) during and after aortic surgery.


Locations(1)

AORN Ospedali dei Colli - Monaldi Hospital

Naples, Italy, Italy

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NCT07541612


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