Cerebral Oximetry for Carotid EEA

• ClinicalTrials.gov Identifier: NCT02203370
• Recruitment Status: Unknown
• First Posted: July 29, 2014
• Last Update Posted: May 20, 2015
• Sponsor: Salzburger Landeskliniken
• 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

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

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

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