Near-infrared monitoring of spinal cord oxygenation during aortic surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.