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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

Tracking Information
First Submitted Date July 24, 2014
First Posted Date July 29, 2014
Last Update Posted Date May 20, 2015
Study Start Date July 2014
Estimated Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 27, 2014)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 27, 2014)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 27, 2014)
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Cerebral Oximetry for Carotid EEA
Official Title Not Provided
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
S100B and NSE blood samples taken twice, before and after the surgical procedure
Sampling Method Non-Probability Sample
Study Population All patients scheduled for CTEA at the University Hospital Salzburg
Condition
  • Carotid Thrombendarterectomy
  • Cerebral Oxygenation
  • NIRS
  • Regional Anesthesia
Intervention Device: NIRS - Near-infrared spectroscopy
Other Name: FORE-SIGHT™ Monitor (CAS Medical Systems, Branford, Connecticut, USA) and INVOS™ (Somanetics, Troy, Michigan, USA)
Study Groups/Cohorts 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.
Intervention: Device: NIRS - Near-infrared spectroscopy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July 27, 2014)
126
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2016
Estimated Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria
Removed Location Countries  
 
Administrative Information
NCT Number NCT02203370
Other Study ID Numbers CerbralOximetry_01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Andreas Kokoefer, Salzburger Landeskliniken
Study Sponsor Salzburger Landeskliniken
Collaborators Not Provided
Investigators
Principal Investigator: Andreas Koköfer, M.D. UK für Anästhesiologie, LKH Salzburg
PRS Account Salzburger Landeskliniken
Verification Date July 2014