NCT07541612 NIRS MONITORING OF SPINAL CORD ISCHEMIA IN AORTIC SURGERY
| NCT ID | NCT07541612 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Monaldi Hospital |
| Condition | Spinal Cord Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-08-23 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2025-08-23 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Salvatore Notaro
PRINCIPAL INVESTIGATOR
AORN Ospedali dei Colli - Monaldi Hospital
Frequently Asked Questions
Who can join the NCT07541612 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spinal Cord Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07541612 currently recruiting?
Yes, NCT07541612 is actively recruiting participants. Contact the research team at salvatore.notaro@ospedalideicolli.it for enrollment information.
Where is the NCT07541612 trial being conducted?
This trial is being conducted at Naples, Italy.
Who is sponsoring the NCT07541612 clinical trial?
NCT07541612 is sponsored by Monaldi Hospital. The principal investigator is Salvatore Notaro at AORN Ospedali dei Colli - Monaldi Hospital. The trial plans to enroll 120 participants.