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NIRS MONITORING OF SPINAL CORD ISCHEMIA IN AORTIC SURGERY

NCT07541612 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2026-04-21

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Near-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.

PROCEDURE

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.

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.

Sponsors & Collaborators

  • Monaldi Hospital

    lead OTHER

Principal Investigators

  • Salvatore Notaro · AORN Ospedali dei Colli - Monaldi Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-23
Primary Completion
2026-12-31
Completion
2027-03-30

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07541612 on ClinicalTrials.gov