Actively Recruiting
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
Eligibility Criteria
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
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
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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