Actively Recruiting

Age: 18Years +
All Genders
NCT07541612

NIRS MONITORING OF SPINAL CORD ISCHEMIA IN AORTIC SURGERY

Led by Monaldi Hospital · Updated on 2026-04-21

120

Participants Needed

1

Research Sites

83 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

NIRS MONITORING OF SPINAL CORD ISCHEMIA IN AORTIC SURGERY

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

AORN Ospedali dei Colli - Monaldi Hospital

Naples, Italy, Italy, 80100

Actively Recruiting

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Research Team

S

Salvatore Notaro

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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NIRS MONITORING OF SPINAL CORD ISCHEMIA IN AORTIC SURGERY | DecenTrialz