<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02203370</url>
  </required_header>
  <id_info>
    <org_study_id>CerbralOximetry_01</org_study_id>
    <nct_id>NCT02203370</nct_id>
  </id_info>
  <brief_title>Cerebral Oximetry for Carotid EEA</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Salzburger Landeskliniken</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Salzburger Landeskliniken</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim oft he study is to compare two different devices for cerebral oximetry (FORE-SIGHTTM&#xD;
      Monitor (CAS Medical Systems, Branford, Connecticut, USA and INVOSTM Somanetics, Troy,&#xD;
      Michigan, USA) in patients undergoing surgical carotid thrombendarterectomy (cTEA) with&#xD;
      crossclamped internal carotid artery (ACI). All procedures will be performed in regional&#xD;
      anesthesia, therefore the patients will be awake and direct neurological examination during&#xD;
      the procedure will be possible, giving information how the drop in cerebral saturation&#xD;
      (measured with INVOS and FORESIGHT both on the same patient) correlates with any clinical&#xD;
      symptoms.&#xD;
&#xD;
      We expect to see a difference in the total drop and in the delay of the drop of cerebral&#xD;
      oxygen saturation, making it possible to detect varieties in specificity and sensitivity of&#xD;
      both devices compared to neurologic examination in the awake patient.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">July 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>absolute tissue saturation (StO2) measured with(FORE-SIGHTTM Monitor (CAS Medical Systems, Branford, Connecticut, USA and INVOSTM Somanetics, Troy, Michigan, USA)</measure>
    <time_frame>During the surgical procedure</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>NSE</measure>
    <time_frame>Before and after the surgery</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>S100B</measure>
    <time_frame>Before and after the surgery</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Hemodynamic parameters</measure>
    <time_frame>During the surgical procedure</time_frame>
    <description>Blood pressure</description>
  </other_outcome>
  <other_outcome>
    <measure>Hemodynamic parameters</measure>
    <time_frame>During the surgical procedure</time_frame>
    <description>Peripheral oxygen saturation</description>
  </other_outcome>
  <other_outcome>
    <measure>Hemodynamic parameters</measure>
    <time_frame>During the surgical procedure</time_frame>
    <description>ECG</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">126</enrollment>
  <condition>Carotid Thrombendarterectomy</condition>
  <condition>Cerebral Oxygenation</condition>
  <condition>NIRS</condition>
  <condition>Regional Anesthesia</condition>
  <arm_group>
    <arm_group_label>all patients</arm_group_label>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NIRS - Near-infrared spectroscopy</intervention_name>
    <arm_group_label>all patients</arm_group_label>
    <other_name>FORE-SIGHT™ Monitor (CAS Medical Systems, Branford, Connecticut, USA) and INVOS™ (Somanetics, Troy, Michigan, USA)</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      S100B and NSE blood samples taken twice, before and after the surgical procedure&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All patients scheduled for CTEA at the University Hospital Salzburg&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Patients with electively scheduled carotid thrombendarterectomy in regional anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refusing participation&#xD;
&#xD;
          -  age &lt;18 years&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  any contraindication to regional anesthesia or the use of NIRS&#xD;
&#xD;
          -  participation in any other study affecting the study protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andreas Koköfer, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>UK für Anästhesiologie, LKH Salzburg</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Andreas Koköfer, M.D.</last_name>
    <phone>0043-662 4482</phone>
    <phone_ext>58664</phone_ext>
    <email>a.kokoefer@salk.at</email>
  </overall_contact>
  <location>
    <facility>
      <name>LKH University Clinic Salzburg</name>
      <address>
        <city>Salzburg</city>
        <zip>5020</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andreas Koköfer, M.D.</last_name>
      <phone>0043 - 662 4482</phone>
      <phone_ext>58664</phone_ext>
      <email>a.kokoefer@salk.at</email>
    </contact>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>May 19, 2015</last_update_submitted>
  <last_update_submitted_qc>May 19, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Salzburger Landeskliniken</investigator_affiliation>
    <investigator_full_name>Andreas Kokoefer</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02203370
org study id: CerbralOximetry_01
nct id: NCT02203370
lead sponsor: 
has dmc: No
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.
observational model: Case-Only
time perspective: Prospective
measure: 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
description: 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.
measure: NSE
time frame: Before and after the surgery
description: 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.
measure: S100B
time frame: Before and after the surgery
description: 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.
measure: Hemodynamic parameters
time frame: During the surgical procedure
description: Blood pressure
measure: Hemodynamic parameters
time frame: During the surgical procedure
description: Peripheral oxygen saturation
measure: Hemodynamic parameters
time frame: During the surgical procedure
description: ECG
arm group label: all patients
description: 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 type: Device
intervention name: NIRS - Near-infrared spectroscopy
arm group label: all patients
other name: FORE-SIGHT™ Monitor (CAS Medical Systems, Branford, Connecticut, USA) and INVOS™ (Somanetics, Troy, Michigan, USA)
S100B and NSE blood samples taken twice, before and after the surgical procedure
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andreas Koköfer, M.D.
role: Principal Investigator
affiliation: UK für Anästhesiologie, LKH Salzburg
last name: Andreas Koköfer, M.D.
phone: 0043-662 4482
phone ext: 58664
email: a.kokoefer@salk.at
facility: 
status: Recruiting
contact: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Salzburger Landeskliniken
investigator full name: Andreas Kokoefer
investigator title: MD