Near-infrared monitoring of spinal cord oxygenation during aortic surgery
MONITORING AND PREVENTION OF SPINAL CORD iSCHEMIA IN AORTIC SURGERY USING PARASPINAL NEAR-INFRARED SPECTROSCOPY (NIRS)
This will try using skin-surface near-infrared sensors on the back to continuously track spinal cord oxygen levels in adults having major thoracic or thoracoabdominal aortic surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Monaldi Hospital Academic / other |
| Locations | 1 site (Naples, Italy) |
| Trial ID | NCT07541612 on ClinicalTrials.gov |
What this trial studies
This single-center prospective observational study places near-infrared spectroscopy (NIRS) sensors bilaterally over paraspinal muscles of adult patients undergoing elective thoracic or thoracoabdominal aortic repair to continuously record regional tissue oxygen saturation (rSO₂) intraoperatively and during the early postoperative period. Routine hemodynamic variables including arterial pressure, heart rate, and when available cardiac output and dynamic indices of fluid responsiveness will be recorded and synchronized with rSO₂ signals. Use of clinical measures such as cerebrospinal fluid drainage via lumbar catheter and other interventions to optimize spinal cord perfusion will be documented but not dictated by the protocol. The study will analyze temporal correlations between paraspinal rSO₂ changes and hemodynamic events to determine feasibility and potential clinical utility as a surrogate monitor for spinal cord perfusion.
Who should consider this trial
Good fit: Adults (≥18 years) scheduled for elective thoracic or thoracoabdominal aortic repair (open, endovascular, or hybrid) who can consent and have skin suitable for NIRS sensor placement are ideal candidates.
Not a fit: Patients under 18, emergency cases, those with pre-existing paraplegia, pregnancy, or skin conditions that prevent correct sensor placement are unlikely to benefit from this monitoring approach.
Why it matters
Potential benefit: If successful, this approach could provide earlier, continuous detection of spinal cord hypoperfusion during aortic surgery and help guide timely interventions to reduce the risk of permanent injury.
How similar studies have performed: Small pilot studies and case reports have shown feasibility and some correlation between paraspinal rSO₂ changes and spinal cord perfusion, but no large trials have yet proven clinical effectiveness.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Naples, Italy
- AORN Ospedali dei Colli - Monaldi Hospital — Naples, Italy, Italy (Recruiting)
Study contacts
- Principal investigator: Salvatore Notaro — AORN Ospedali dei Colli - Monaldi Hospital
- Study coordinator: Salvatore Notaro
- Email: salvatore.notaro@ospedalideicolli.it
- Phone: +393299744318
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.