NIRS MONITORING OF SPINAL CORD ISCHEMIA IN AORTIC SURGERY

NCT07541612 | Recruiting

• 1 other identifier: LOC-1000704
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

Near-Infrared Spectroscopy

Outcome Measures

Primary Outcomes (1)

• Intraoperative detection of spinal cord ischemia by paraspinal NIRS

  Incidence of intraoperative spinal cord ischemia identified by significant reduction in paraspinal regional oxygen saturation measured with near-infrared spectroscopy during thoracoabdominal aortic surgery.

  From anesthesia induction until completion of surgery

Study Arms (2)

High-risk patients (NIRS + CSF drainage)

Patients at high risk of spinal cord ischemia undergoing aortic surgery, managed with paraspinal near-infrared spectroscopy (NIRS) monitoring combined with cerebrospinal fluid (CSF) drainage according to the study protocol.

Diagnostic Test: Near-Infrared Spectroscopy (NIRS); 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.

Low-risk patients (NIRS alone)

Patients at lower risk of spinal cord ischemia undergoing aortic surgery, managed with paraspinal near-infrared spectroscopy (NIRS) monitoring without cerebrospinal fluid drainage according to the study protocol.

Diagnostic Test: Near-Infrared Spectroscopy (NIRS)

Interventions

Near-Infrared Spectroscopy (NIRS) DIAGNOSTIC_TEST

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.

Also known as: NIRS MONITORING, REGIONAL OXIMETRY, rSO2 monitoring, Near-Infrared Spectroscopy

High-risk patients (NIRS + CSF drainage); Low-risk patients (NIRS alone)

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. PROCEDURE

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.

Also known as: CSF DRAINAGE, LUMBAR DRANAIGE, CEREBROSPINAL FLUID DRANAIGE, SPINAL DRANAIGE

High-risk patients (NIRS + CSF drainage)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients undergoing elective thoracic and thoracoabdominal aortic repair procedures, including open, endovascular (TEVAR/FEVAR), and hybrid interventions, at Monaldi Hospital, A.O.R.N. Ospedali dei Colli, Naples, Italy. Participants will be recruited consecutively from the vascular and cardiovascular surgical units where intraoperative spinal cord monitoring is routinely performed.

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• Monaldi Hospital: lead

Study Sites (1)

AORN Ospedali dei Colli - Monaldi Hospital

Naples, Italy, 80100, Italy

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Salvatore Notaro

  AORN Ospedali dei Colli - Monaldi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Salvatore Notaro

CONTACT

+393299744318; salvatore.notaro@ospedalideicolli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Anesthesiologist and Intensive Care Specialist

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 21, 2026
• Study Start: August 23, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-03

Locations

IT (1)