MONITORING AND PREVENTION OF SPINAL CORD iSCHEMIA IN AORTIC SURGERY USING PARASPINAL NEAR-INFRARED SPECTROSCOPY (NIRS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Intraoperative detection of spinal cord ischemia by paraspinal NIRS
研究概览
简要总结
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.
详细描述
pinal cord ischemia is a rare but severe complication associated with major surgical procedures, particularly in patients undergoing complex hemodynamic management. Early detection of impaired spinal cord perfusion remains challenging due to the lack of reliable, continuous, and non-invasive monitoring tools. Current monitoring strategies are indirect and often fail to provide timely information on regional perfusion changes.
Near-infrared spectroscopy (NIRS) is a non-invasive technique that measures regional tissue oxygen saturation (rSO₂) by analyzing the absorption of infrared light by oxygenated and deoxygenated hemoglobin. When applied to paraspinal muscles, NIRS may reflect local microcirculatory changes and potentially serve as a surrogate marker of spinal cord perfusion.
This is a single-center, prospective observational study designed to investigate the feasibility and clinical applicability of paraspinal NIRS monitoring in adult patients undergoing major noncardiac surgery requiring advanced hemodynamic monitoring. Patients will be monitored intraoperatively and during the early postoperative period using NIRS sensors placed bilaterally over the paraspinal regions.
Continuous rSO₂ measurements will be collected and integrated with routinely monitored hemodynamic variables, including arterial blood pressure, heart rate, and, when available, advanced parameters such as cardiac output and dynamic indices of fluid responsiveness. Data will be recorded at predefined time points and during relevant clinical events, such as induction of anesthesia, surgical phases, hemodynamic instability, and postoperative recovery.
The study aims to explore the physiological relationship between paraspinal rSO₂ and systemic hemodynamic changes, as well as to assess the feasibility, signal stability, and reproducibility of NIRS measurements in the perioperative setting. Particular attention will be given to identifying patterns of rSO₂ variation associated with hemodynamic fluctuations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Near-Infrared Spectroscopy (NIRS) (Diagnostic Test)
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.
干预措施: 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)
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.
干预措施: Near-Infrared Spectroscopy (NIRS) (Diagnostic Test)
结局指标
主要结局
Intraoperative detection of spinal cord ischemia by paraspinal NIRS
时间窗: From anesthesia induction until completion of surgery
Incidence of intraoperative spinal cord ischemia identified by significant reduction in paraspinal regional oxygen saturation measured with near-infrared spectroscopy during thoracoabdominal aortic surgery.
次要结局
未报告次要终点
研究者
Salvatore Notaro
Principal Investigator, Anesthesiologist and Intensive Care Specialist
Monaldi Hospital