MonitoringSINATRANCT03074487
Evaluating Monitoring Techniques for Postoperative Spinal Cord Ischemia
An observational study of Monitoring and Postoperative, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
During open surgery of a thoraco-abdominal aortic aneurysma (TAAA), diminished blood flow to the myelum can result in hypoxia, compromising proper function of the spinal cord. Intraoperatively, motor evoked potentials (MEP) are elicited to measure the functional integrity of the spinal cord. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Monitoring, Postoperative, Spinal Cord Ischemia
- What is being tested?
- Near-infrared spectroscopy and Long loop reflex measurements
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2017to Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients undergoing a thoraco-abdominal aortic aneurysm (TAAA) repair by either open surgical or endovascular procedures are eligible for inclusion. The study population will include patients undergoing TAAA repair in Maastricht (Netherlands), Aachen (Germany) and Bern, (Switzerland).
Who may be able to join
- Thoraco-abdominal aneurysm (TAA) of the descending aorta: Crawford type I,II, III, IV or V
- Repair using open surgical or endovascular procedure.
- Undergoing monitoring by motor evoked potentials (MEP) as part of the standard surgical procedure.
Who cannot join
- Aneurysm only in ascending part of the aorta
- Standard contraindications for motor evoked potential (MEP) monitoring.
- Standard contraindications for electrode placement (skin wounds, etc.)
- No informed consent can be obtained prior to the procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploratory Study Regarding the Use of Neurophysiological Monitoring Techniques to Detect Spinal Cord Ischemia in Patients After Thoracoabdominal Aortic Aneurysm Repair
During open surgery of a thoraco-abdominal aortic aneurysma (TAAA), diminished blood flow to the myelum can result in hypoxia, compromising proper function of the spinal cord.
Intraoperatively, motor evoked potentials (MEP) are elicited to measure the functional integrity of the spinal cord. MEPs have proven to be a reliable marker of spinal cord ischemia. Moreover, these potentials react within minutes, which facilitates interventions to restore the blood flow. Monitoring intraoperatively with this ancillary test has reduced the rate of paraparesis to < 5%. Unfortunately, in the early postoperative period, spinal cord vulnerability is high. Therefore, some patients develop paraparesis, not during the surgical procedure, but after the surgical procedure. Postoperatively, suboptimal blood flow may lead to critical loss of function. This inadequate perfusion results in "delayed paraparesis". In the postoperative patient, it is not possible to measure MEPs when sedation is decreased, due to the high intensity of the electrical stimulus, which is unacceptably painful in the unanesthetized or partially anesthetized patient. Therefore ancillary tests are needed which can detect spinal cord ischemia postoperatively early, thus preceding the phase with clinically overt paraparesis. The test should be reliable and easy to perform for an extended period of time (up to several days).
Read more
The purpose of this study is to explore the usefulness of various neurophysiological tests regarding accuracy and feasibility for the detection of spinal cord ischemia. In particular, to find a diagnostic test which is acceptable for the unanesthetized or partially anesthetized patient and therefore can also be performed postoperatively. These tests will be examined in fully sedated as well as partially sedated patients.
The following candidate tests will be examined:
- Long loop reflexes (LLR) consisting of F-waves.
- Oxygenation measurements of the paraspinal muscles using Near-infrared spectroscopy (NIRS).
- Conditions
- Monitoring, Postoperative, Spinal Cord Ischemia, Thoracoabdominal Aneurysm, TAAA, NIRS
- Being tested
- Near-infrared spectroscopy, Long loop reflex measurements
- Keywords
- Spinal cord ischemia, Postoperative, Thoracoabdominal Aneurysm, Monitoring
- Medical subject headings
- Spinal Cord Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-infrared spectroscopyDevice
Also called NIRS
Long loop reflex measurementsDevice
Also called F-waves
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in MEP signals perioperative
These signals will be recoded into categorical variables. To determine associations logistic regression analysis will be performed (univariate and multivariate adjusting for confounders). Screening test calculations (sensitivity, specificity, positive and negative predictive values, false-positive and false-negative rates) will be performed using standard contingency table methods. Agreement between the methods (vs MEP) will be estimated using the Cohen k statistic. The results will first be evaluated descriptively to fine-tune the cut-off values in de the definitive protocol.
Measured: 8 hours
Presence of LLR (F-waves) perioperative
These signals will be recoded into categorical variables. To determine associations logistic regression analysis will be performed (univariate and multivariate adjusting for confounders). Screening test calculations (sensitivity, specificity, positive and negative predictive values, false-positive and false-negative rates) will be performed using standard contingency table methods. Agreement between the methods (vs MEP) will be estimated using the Cohen k statistic. The results will first be evaluated descriptively to fine-tune the cut-off values in de the definitive protocol.
Measured: 8 hours
Oxygenation of the paraspinal muscle tissue measured by NIRS perioperative
These signals will be recoded into categorical variables. To determine associations logistic regression analysis will be performed (univariate and multivariate adjusting for confounders). Screening test calculations (sensitivity, specificity, positive and negative predictive values, false-positive and false-negative rates) will be performed using standard contingency table methods. Agreement between the methods (vs MEP) will be estimated using the Cohen k statistic. The results will first be evaluated descriptively to fine-tune the cut-off values in de the definitive protocol.
Measured: 8 hours
Secondary outcomes (2)
The occurrence of intra- and postoperative changes in LLR (F-waves)
These signals will be recoded into categorical variables. To determine associations logistic regression analysis will be performed (univariate and multivariate adjusting for confounders). Screening test calculations (sensitivity, specificity, positive and negative predictive values, false-positive and false-negative rates) will be performed using standard contingency table methods. The results will first be evaluated descriptively to fine-tune the cut-off values in de the definitive protocol.
Measured: 24 hours
The occurrence intra- and postoperative changesNIRS of the paraspinal muscle tissue
These signals will be recoded into categorical variables. To determine associations logistic regression analysis will be performed (univariate and multivariate adjusting for confounders). Screening test calculations (sensitivity, specificity, positive and negative predictive values, false-positive and false-negative rates) will be performed using standard contingency table methods. The results will first be evaluated descriptively to fine-tune the cut-off values in de the definitive protocol.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study startJan 2017
- Primary completionMar 2025
- Study completionApr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for MonitoringStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074487
- Sponsor's protocol ID
- NL58137.068.16
- Acronym
- SINATRA
- Status last verified
- May 2025
- First submitted
- 21 Feb 2017
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jacobs MJ, Mess W, Mochtar B, Nijenhuis RJ, Statius van Eps RG, Schurink GW. The value of motor evoked potentials in reducing paraplegia during thoracoabdominal aneurysm repair. J Vasc Surg. 2006 Feb;43(2):239-46. doi: 10.1016/j.jvs.2005.09.042.
PubMed 16476594Greiner A, Mess WH, Schmidli J, Debus ES, Grommes J, Dick F, Jacobs MJ. Cyber medicine enables remote neuromonitoring during aortic surgery. J Vasc Surg. 2012 May;55(5):1227-32; discussion 1232-3. doi: 10.1016/j.jvs.2011.11.121. Epub 2012 Feb 15.
PubMed 22341581Armstrong KL, Wood D. Can infant death from child abuse be prevented? Med J Aust. 1992 Feb 17;156(4):290. doi: 10.5694/j.1326-5377.1992.tb139757.x. No abstract available.
PubMed 1738333Etz CD, Di Luozzo G, Zoli S, Lazala R, Plestis KA, Bodian CA, Griepp RB. Direct spinal cord perfusion pressure monitoring in extensive distal aortic aneurysm repair. Ann Thorac Surg. 2009 Jun;87(6):1764-73; discussion 1773-4. doi: 10.1016/j.athoracsur.2009.02.101.
PubMed 19463592Jacobs MJ, Mess WH. The role of evoked potential monitoring in operative management of type I and type II thoracoabdominal aortic aneurysms. Semin Thorac Cardiovasc Surg. 2003 Oct;15(4):353-64. doi: 10.1053/s1043-0679(03)00084-4.
PubMed 14710377Etz CD, von Aspern K, Gudehus S, Luehr M, Girrbach FF, Ender J, Borger M, Mohr FW. Near-infrared spectroscopy monitoring of the collateral network prior to, during, and after thoracoabdominal aortic repair: a pilot study. Eur J Vasc Endovasc Surg. 2013 Dec;46(6):651-6. doi: 10.1016/j.ejvs.2013.08.018. Epub 2013 Sep 5.
PubMed 24099957Moerman A, Van Herzeele I, Vanpeteghem C, Vermassen F, Francois K, Wouters P. Near-infrared spectroscopy for monitoring spinal cord ischemia during hybrid thoracoabdominal aortic aneurysm repair. J Endovasc Ther. 2011 Feb;18(1):91-5. doi: 10.1583/10-3224.1.
PubMed 21314355Boezeman RP, van Dongen EP, Morshuis WJ, Sonker U, Boezeman EH, Waanders FG, de Vries JP. Spinal near-infrared spectroscopy measurements during and after thoracoabdominal aortic aneurysm repair: a pilot study. Ann Thorac Surg. 2015 Apr;99(4):1267-74. doi: 10.1016/j.athoracsur.2014.10.032. Epub 2015 Jan 14.
PubMed 25596871
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study Regarding the Use of Neurophysiological Monitoring Techniques to Detect Spinal Cord Ischemia in Patients After Thoracoabdominal Aortic Aneurysm Repair
- ClinicalTrials.gov ID
- NCT03074487
- Acronym / sponsor ID
- SINATRA / NL58137.068.16
- Conditions
- Monitoring, Postoperative, Spinal Cord Ischemia, Thoracoabdominal Aneurysm, TAAA, NIRS
- Keywords
- Spinal cord ischemia, Postoperative, Thoracoabdominal Aneurysm, Monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Mar 2025 (actual)
- Study completion
- Apr 2025 (actual)
- First posted
- 8 Mar 2017 (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.
During open surgery of a thoraco-abdominal aortic aneurysma (TAAA), diminished blood flow to the myelum can result in hypoxia, compromising proper function of the spinal cord.
Intraoperatively, motor evoked potentials (MEP) are elicited to measure the functional integrity of the spinal cord. MEPs have proven to be a reliable marker of spinal cord ischemia. Moreover, these potentials react within minutes, which facilitates interventions to restore the blood flow. Monitoring intraoperatively with this ancillary test has reduced the rate of paraparesis to < 5%. Unfortunately, in the early postoperative period, spinal cord vulnerability is high. Therefore, some patients develop paraparesis, not during the surgical procedure, but after the surgical procedure. Postoperatively, suboptimal blood flow may lead to critical loss of function. This inadequate perfusion results in "delayed paraparesis". In the postoperative patient, it is not possible to measure MEPs when sedation is decreased, due to the high intensity of the electrical stimulus, which is unacceptably painful in the unanesthetized or partially anesthetized patient. Therefore ancillary tests are needed which can detect spinal cord ischemia postoperatively early, thus preceding the phase with clinically overt paraparesis. The test should be reliable and easy to perform for an extended period of time (up to several days).
The purpose of this study is to explore the usefulness of various neurophysiological tests regarding accuracy and feasibility for the detection of spinal cord ischemia. In particular, to find a diagnostic test which is acceptable for the unanesthetized or partially anesthetized patient and therefore can also be performed postoperatively. These tests will be examined in fully sedated as well as partially sedated patients.
The following candidate tests will be examined:
- Long loop reflexes (LLR) consisting of F-waves.
- Oxygenation measurements of the paraspinal muscles using Near-infrared spectroscopy (NIRS).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing a thoraco-abdominal aortic aneurysm (TAAA) repair by either open surgical or endovascular procedures are eligible for inclusion. The study population will include patients undergoing TAAA repair in Maastricht (Netherlands), Aachen (Germany) and Bern, (Switzerland).
Key inclusion criteria (3 listed)
- Thoraco-abdominal aneurysm (TAA) of the descending aorta: Crawford type I,II, III, IV or V
- Repair using open surgical or endovascular procedure.
- Undergoing monitoring by motor evoked potentials (MEP) as part of the standard surgical procedure.
Key exclusion criteria (4 listed)
- Aneurysm only in ascending part of the aorta
- Standard contraindications for motor evoked potential (MEP) monitoring.
- Standard contraindications for electrode placement (skin wounds, etc.)
- No informed consent can be obtained prior to the procedure
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 spectroscopyAlso: NIRS | Device | – |
| Long loop reflex measurementsAlso: F-waves | Device | – |
Primary outcome
changes in MEP signals perioperative
Time frame: 8 hours
These signals will be recoded into categorical variables. To determine associations logistic regression analysis will be performed (univariate and multivariate adjusting for confounders). Screening test calculations (sensitivity, specificity, positive and negative predictive values, false-positive and false-negative rates) will be performed using standard contingency table methods. Agreement between the methods (vs MEP) will be estimated using the Cohen k statistic. The results will first be evaluated descriptively to fine-tune the cut-off values in de the definitive protocol.
Presence of LLR (F-waves) perioperative
Time frame: 8 hours
These signals will be recoded into categorical variables. To determine associations logistic regression analysis will be performed (univariate and multivariate adjusting for confounders). Screening test calculations (sensitivity, specificity, positive and negative predictive values, false-positive and false-negative rates) will be performed using standard contingency table methods. Agreement between the methods (vs MEP) will be estimated using the Cohen k statistic. The results will first be evaluated descriptively to fine-tune the cut-off values in de the definitive protocol.
Oxygenation of the paraspinal muscle tissue measured by NIRS perioperative
Time frame: 8 hours
These signals will be recoded into categorical variables. To determine associations logistic regression analysis will be performed (univariate and multivariate adjusting for confounders). Screening test calculations (sensitivity, specificity, positive and negative predictive values, false-positive and false-negative rates) will be performed using standard contingency table methods. Agreement between the methods (vs MEP) will be estimated using the Cohen k statistic. The results will first be evaluated descriptively to fine-tune the cut-off values in de the definitive protocol.
2 secondary outcomes
The occurrence of intra- and postoperative changes in LLR (F-waves)
Time frame: 24 hours
The occurrence intra- and postoperative changesNIRS of the paraspinal muscle tissue
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Background: PubMed 16476594Jacobs MJ, Mess W, Mochtar B, Nijenhuis RJ, Statius van Eps RG, Schurink GW. The value of motor evoked potentials in reducing paraplegia during thoracoabdominal aneurysm repair. J Vasc Surg. 2006 Feb;43(2):239-46. doi: 10.1016/j.jvs.2005.09.042.
- Background: PubMed 22341581Greiner A, Mess WH, Schmidli J, Debus ES, Grommes J, Dick F, Jacobs MJ. Cyber medicine enables remote neuromonitoring during aortic surgery. J Vasc Surg. 2012 May;55(5):1227-32; discussion 1232-3. doi: 10.1016/j.jvs.2011.11.121. Epub 2012 Feb 15.
- Background: PubMed 1738333Armstrong KL, Wood D. Can infant death from child abuse be prevented? Med J Aust. 1992 Feb 17;156(4):290. doi: 10.5694/j.1326-5377.1992.tb139757.x. No abstract available.
- Background: PubMed 19463592Etz CD, Di Luozzo G, Zoli S, Lazala R, Plestis KA, Bodian CA, Griepp RB. Direct spinal cord perfusion pressure monitoring in extensive distal aortic aneurysm repair. Ann Thorac Surg. 2009 Jun;87(6):1764-73; discussion 1773-4. doi: 10.1016/j.athoracsur.2009.02.101.
- Background: PubMed 14710377Jacobs MJ, Mess WH. The role of evoked potential monitoring in operative management of type I and type II thoracoabdominal aortic aneurysms. Semin Thorac Cardiovasc Surg. 2003 Oct;15(4):353-64. doi: 10.1053/s1043-0679(03)00084-4.
- Background: PubMed 24099957Etz CD, von Aspern K, Gudehus S, Luehr M, Girrbach FF, Ender J, Borger M, Mohr FW. Near-infrared spectroscopy monitoring of the collateral network prior to, during, and after thoracoabdominal aortic repair: a pilot study. Eur J Vasc Endovasc Surg. 2013 Dec;46(6):651-6. doi: 10.1016/j.ejvs.2013.08.018. Epub 2013 Sep 5.
- Background: PubMed 21314355Moerman A, Van Herzeele I, Vanpeteghem C, Vermassen F, Francois K, Wouters P. Near-infrared spectroscopy for monitoring spinal cord ischemia during hybrid thoracoabdominal aortic aneurysm repair. J Endovasc Ther. 2011 Feb;18(1):91-5. doi: 10.1583/10-3224.1.
- Background: PubMed 25596871Boezeman RP, van Dongen EP, Morshuis WJ, Sonker U, Boezeman EH, Waanders FG, de Vries JP. Spinal near-infrared spectroscopy measurements during and after thoracoabdominal aortic aneurysm repair: a pilot study. Ann Thorac Surg. 2015 Apr;99(4):1267-74. doi: 10.1016/j.athoracsur.2014.10.032. Epub 2015 Jan 14.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Monitoring and Postoperative, run by Maastricht University Medical Center at 1 site in Netherlands.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 1 Oct 2025. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in MEP signals perioperative (time frame: 8 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03074487, which also lists 8 linked publications.
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 1 Oct 2025.