Cerebral Oximetry for Carotid EEA
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ClinicalTrials.gov Identifier: NCT02203370 |
Recruitment Status : Unknown
Verified July 2014 by Andreas Kokoefer, Salzburger Landeskliniken.
Recruitment status was: Recruiting
First Posted : July 29, 2014
Last Update Posted : May 20, 2015
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Aim oft he study is to compare two different devices for cerebral oximetry (FORE-SIGHTTM Monitor (CAS Medical Systems, Branford, Connecticut, USA and INVOSTM Somanetics, Troy, Michigan, USA) in patients undergoing surgical carotid thrombendarterectomy (cTEA) with crossclamped internal carotid artery (ACI). All procedures will be performed in regional anesthesia, therefore the patients will be awake and direct neurological examination during the procedure will be possible, giving information how the drop in cerebral saturation (measured with INVOS and FORESIGHT both on the same patient) correlates with any clinical symptoms.
We expect to see a difference in the total drop and in the delay of the drop of cerebral oxygen saturation, making it possible to detect varieties in specificity and sensitivity of both devices compared to neurologic examination in the awake patient.
Condition or disease | Intervention/treatment |
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Carotid Thrombendarterectomy Cerebral Oxygenation NIRS Regional Anesthesia | Device: NIRS - Near-infrared spectroscopy |
Study Type : | Observational |
Estimated Enrollment : | 126 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Study Start Date : | July 2014 |
Estimated Primary Completion Date : | July 2015 |
Estimated Study Completion Date : | December 2016 |
Group/Cohort | Intervention/treatment |
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all patients
All patients will be measured throughout the procedure with both devices. There no further separation into groups as both sensors can be placed on the same patient.
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Device: NIRS - Near-infrared spectroscopy
Other Name: FORE-SIGHT™ Monitor (CAS Medical Systems, Branford, Connecticut, USA) and INVOS™ (Somanetics, Troy, Michigan, USA) |
- absolute tissue saturation (StO2) measured with(FORE-SIGHTTM Monitor (CAS Medical Systems, Branford, Connecticut, USA and INVOSTM Somanetics, Troy, Michigan, USA) [ Time Frame: During the surgical procedure ]The drop in StO2 will be compared to the occurrence of any clinical i.e. neurological symptoms during clamping o the carotid artery while cTEA is performed.
- NSE [ Time Frame: Before and after the surgery ]Biomarker for ischemic brain damage. Serum levels neuron specific enolase (NSE) increases in patients during the acute phase of brain damage. Therefore it is measured to find out whether or not there is correlation to a low oxygen saturation without neurological symptoms during cTEA.
- S100B [ Time Frame: Before and after the surgery ]Biomarker for ischemic brain damage. Serum levels of S100B increases in patients during the acute phase of brain damage. Therefore it is measured to find out whether or not there is correlation to a low oxygen saturation without neurological symptoms during cTEA.
- Hemodynamic parameters [ Time Frame: During the surgical procedure ]Blood pressure
- Hemodynamic parameters [ Time Frame: During the surgical procedure ]Peripheral oxygen saturation
- Hemodynamic parameters [ Time Frame: During the surgical procedure ]ECG
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patients with electively scheduled carotid thrombendarterectomy in regional anesthesia
Exclusion Criteria:
- refusing participation
- age <18 years
- pregnancy
- any contraindication to regional anesthesia or the use of NIRS
- participation in any other study affecting the study protocol

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02203370
Contact: Andreas Koköfer, M.D. | 0043-662 4482 ext 58664 | a.kokoefer@salk.at |
Austria | |
LKH University Clinic Salzburg | Recruiting |
Salzburg, Austria, 5020 | |
Contact: Andreas Koköfer, M.D. 0043 - 662 4482 ext 58664 a.kokoefer@salk.at |
Principal Investigator: | Andreas Koköfer, M.D. | UK für Anästhesiologie, LKH Salzburg |
Responsible Party: | Andreas Kokoefer, MD, Salzburger Landeskliniken |
ClinicalTrials.gov Identifier: | NCT02203370 |
Other Study ID Numbers: |
CerbralOximetry_01 |
First Posted: | July 29, 2014 Key Record Dates |
Last Update Posted: | May 20, 2015 |
Last Verified: | July 2014 |