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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
Sponsor:
Information provided by (Responsible Party):
Andreas Kokoefer, Salzburger Landeskliniken

Study Description
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Brief Summary:

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
Carotid Thrombendarterectomy Cerebral Oxygenation NIRS Regional Anesthesia Device: NIRS - Near-infrared spectroscopy

Study Design
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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
Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Device: NIRS - Near-infrared spectroscopy
Other Name: FORE-SIGHT™ Monitor (CAS Medical Systems, Branford, Connecticut, USA) and INVOS™ (Somanetics, Troy, Michigan, USA)


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. Hemodynamic parameters [ Time Frame: During the surgical procedure ]
    Blood pressure

  2. Hemodynamic parameters [ Time Frame: During the surgical procedure ]
    Peripheral oxygen saturation

  3. Hemodynamic parameters [ Time Frame: During the surgical procedure ]
    ECG


Biospecimen Retention:   Samples Without DNA
S100B and NSE blood samples taken twice, before and after the surgical procedure

Eligibility Criteria
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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
Study Population
All patients scheduled for CTEA at the University Hospital Salzburg
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Andreas Koköfer, M.D. 0043-662 4482 ext 58664 a.kokoefer@salk.at

Locations
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Austria
LKH University Clinic Salzburg Recruiting
Salzburg, Austria, 5020
Contact: Andreas Koköfer, M.D.    0043 - 662 4482 ext 58664    a.kokoefer@salk.at   
Sponsors and Collaborators
Salzburger Landeskliniken
Investigators
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Principal Investigator: Andreas Koköfer, M.D. UK für Anästhesiologie, LKH Salzburg
More Information
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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