Spinal Cord InjurySPINE-NIRSNCT07541612
NIRS MONITORING OF SPINAL CORD ISCHEMIA IN AORTIC SURGERY
An observational study of Spinal Cord Injury, run by Monaldi Hospital at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Near-Infrared Spectroscopy (NIRS) and 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.
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 23 Aug 2025to 30 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
AORN Ospedali dei Colli - Monaldi Hospital
Naples, Italy, 80100
Salvatore Notaro, MD, 3299744318, salvatore.notaro@ospedalideicolli.it
Eugenio Piscitelli, MD
About this study
Official title: MONITORING AND PREVENTION OF SPINAL CORD iSCHEMIA IN AORTIC SURGERY USING PARASPINAL NEAR-INFRARED SPECTROSCOPY (NIRS)
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.
Read more
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.
Read the detailed description
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.
Data will be prospectively collected using standardized case report forms (CRFs). Data quality will be ensured through predefined data entry procedures, consistency checks, and periodic review of collected variables. All data will be anonymized prior to analysis.
A descriptive statistical approach will be used to summarize baseline characteristics and perioperative variables. Exploratory analyses will be conducted to evaluate the association between rSO₂ trends and hemodynamic parameters. Where appropriate, correlation analyses and regression models may be applied to investigate potential predictors of rSO₂ variation.
Given the exploratory nature of the study, no formal sample size calculation is required; however, enrollment is planned to ensure an adequate representation of the target population and to allow meaningful exploratory analysis.
This study is expected to provide preliminary evidence on the role of paraspinal NIRS monitoring as a non-invasive bedside tool for assessing tissue oxygenation and potentially guiding perioperative hemodynamic management strategies.
- Conditions
- Spinal Cord Injury
- Being tested
- Near-Infrared Spectroscopy (NIRS), 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.
- Keywords
- Near-Infrared Spectroscopy
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-Infrared Spectroscopy (NIRS)Diagnostic test
Also called NIRS MONITORING, REGIONAL OXIMETRY, rSO2 monitoring, Near-Infrared Spectroscopy
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.
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 or surgery
Also called CSF DRAINAGE, LUMBAR DRANAIGE, CEREBROSPINAL FLUID DRANAIGE, SPINAL DRANAIGE
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Near-Infrared Spectroscopy (NIRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From anesthesia induction until completion of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start23 Aug 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Monaldi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salvatore Notaro, Monaldi Hospital
- Investigators
- Salvatore Notaro, Principal investigator, AORN Ospedali dei Colli - Monaldi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541612
- Sponsor's protocol ID
- LOC-1000704
- Acronym
- SPINE-NIRS
- Status last verified
- Mar 2026
- First submitted
- 14 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MONITORING AND PREVENTION OF SPINAL CORD iSCHEMIA IN AORTIC SURGERY USING PARASPINAL NEAR-INFRARED SPECTROSCOPY (NIRS)
- ClinicalTrials.gov ID
- NCT07541612
- Acronym / sponsor ID
- SPINE-NIRS / LOC-1000704
- Conditions
- Spinal Cord Injury
- Keywords
- Near-Infrared Spectroscopy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Monaldi HospitalUniversity, hospital or other
- Study start
- 23 Aug 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Data will be prospectively collected using standardized case report forms (CRFs). Data quality will be ensured through predefined data entry procedures, consistency checks, and periodic review of collected variables. All data will be anonymized prior to analysis.
A descriptive statistical approach will be used to summarize baseline characteristics and perioperative variables. Exploratory analyses will be conducted to evaluate the association between rSO₂ trends and hemodynamic parameters. Where appropriate, correlation analyses and regression models may be applied to investigate potential predictors of rSO₂ variation.
Given the exploratory nature of the study, no formal sample size calculation is required; however, enrollment is planned to ensure an adequate representation of the target population and to allow meaningful exploratory analysis.
This study is expected to provide preliminary evidence on the role of paraspinal NIRS monitoring as a non-invasive bedside tool for assessing tissue oxygenation and potentially guiding perioperative hemodynamic management strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-risk patients (NIRS + CSF drainage) | – | 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.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. |
| Low-risk patients (NIRS alone) | – | Diagnostic Test: Near-Infrared Spectroscopy (NIRS)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Near-Infrared Spectroscopy (NIRS)Also: NIRS MONITORING, REGIONAL OXIMETRY, rSO2 monitoring, Near-Infrared SpectroscopyParaspinal 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. | Diagnostic test | 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.Also: CSF DRAINAGE, LUMBAR DRANAIGE, CEREBROSPINAL FLUID DRANAIGE, SPINAL DRANAIGEA 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. | Procedure or surgery | High-risk patients (NIRS + CSF drainage) |
Primary outcome
Intraoperative detection of spinal cord ischemia by paraspinal NIRS
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Salvatore Notaro principal investigator
AORN Ospedali dei Colli - Monaldi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury, run by Monaldi Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Salvatore Notaro (+393299744318, salvatore.notaro@ospedalideicolli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative detection of spinal cord ischemia by paraspinal NIRS (time frame: From anesthesia induction until completion of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.