<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/NCT02230358</url>
  </required_header>
  <id_info>
    <org_study_id>CODUCE</org_study_id>
    <nct_id>NCT02230358</nct_id>
  </id_info>
  <brief_title>Cardiac Output and Duplex Sonography in Carotid Endarterectomy</brief_title>
  <official_title>Cardiac Output and Cerebral Blood-flow During Carotid Endarterectomy in Regional vs. General Anesthesia. A Prospective Randomized Controlled Single Center Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University Innsbruck</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University Innsbruck</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to investigate the differences between the cardiac output and the&#xD;
      cerebral blood-flow between a regional anesthesia (RA) and a general anesthesia (GA) in a&#xD;
      randomized, controlled, single center study at the Medical University Innsbruck, Department&#xD;
      of Anesthesia and Intensive Care Medicine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will investigate the differences between the cardiac output and the&#xD;
      cerebral blood-flow between a regional anesthesia (RA) and a general anesthesia (GA) in a&#xD;
      randomized, controlled, single center study at the Medical University Innsbruck, Department&#xD;
      of Anesthesia and Intensive Care Medicine.&#xD;
&#xD;
      For this purpose patients with the need of a carotid endarterectomy (CEA) will be included&#xD;
      and randomized either to the regional anesthesia (RA) or the general anesthesia (GA) group&#xD;
      until a patient number of 45 in each group is achieved.&#xD;
&#xD;
      The cardiac output and cerebral blood-flow via trans-cranial Doppler (TCD) will be measured&#xD;
      at 6 time points:&#xD;
&#xD;
        -  T0 Baseline (after insertion of an arterial line)&#xD;
&#xD;
        -  T1 After induction of anesthesia, but before surgical start&#xD;
&#xD;
        -  T2 Two minutes after clamping the carotid artery&#xD;
&#xD;
        -  T3 Two minutes after shunt insertation of the carotid artery&#xD;
&#xD;
        -  T4 After reperfusion&#xD;
&#xD;
        -  T5 After completion of the skin suture&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Influence of anesthetic technique on cardiac output during carotid endarterectomy.</measure>
    <time_frame>Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit</time_frame>
    <description>Number of participants: 90 patients&#xD;
Unit of measure: Cardiac index (l/m2)&#xD;
Cardiac output will be measured and compared at the following time points:&#xD;
T0 Baseline (after insertion of an arterial line)&#xD;
T1 After induction of anesthesia, but before surgical start&#xD;
T2 Two minutes after clamping the carotid artery&#xD;
T3 Two minutes after shunt insertation of the carotid artery&#xD;
T4 After reperfusion&#xD;
T5 After completion of the skin suture</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Influence of anesthetic technique on trans-cranial doppler flow during carotid endarterectomy.</measure>
    <time_frame>Change of cardiac output from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit</time_frame>
    <description>Cerebral blood flow will be measured via trans-cranial Doppler (TCD) and compared at the following time points:&#xD;
T0 Baseline (after insertion of an arterial line)&#xD;
T1 After induction of anesthesia, but before surgical start&#xD;
T2 Two minutes after clamping the carotid artery&#xD;
T3 Two minutes after shunt insertation of the carotid artery&#xD;
T4 After reperfusion&#xD;
T5 After completion of the skin suture</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Influence of anesthetic technique on near infrared spectroscopy during carotid endarterectomy.</measure>
    <time_frame>Change of cardiac output from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit</time_frame>
    <description>Number of participants: 90 patients&#xD;
Unit of measure: blood flow, volume and absolute tissue saturation&#xD;
Near infrared spectroscopy will be measured and compared at the following time points:&#xD;
T0 Baseline (after insertion of an arterial line)&#xD;
T1 After induction of anesthesia, but before surgical start&#xD;
T2 Two minutes after clamping the carotid artery&#xD;
T3 Two minutes after shunt insertation of the carotid artery&#xD;
T4 After reperfusion&#xD;
T5 After completion of the skin suture</description>
  </other_outcome>
  <other_outcome>
    <measure>Influence of anesthetic technique on blood pressure during carotid endarterectomy.</measure>
    <time_frame>Change of blood pressure, from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit</time_frame>
    <description>Number of participants: 90 patients&#xD;
Unit of measure: blood pressure in mmHg&#xD;
Blood pressure will be measured and compared at the following time points:&#xD;
T0 Baseline (after insertion of an arterial line)&#xD;
T1 After induction of anesthesia, but before surgical start&#xD;
T2 Two minutes after clamping the carotid artery&#xD;
T3 Two minutes after shunt insertation of the carotid artery&#xD;
T4 After reperfusion&#xD;
T5 After completion of the skin suture</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of participants with death.</measure>
    <time_frame>Up to 6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of participants with transient ischemic attack and neck hematoma requiring surgical revision.</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 5 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of participants with myocardial infarction.</measure>
    <time_frame>Up to 6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of participants with stroke.</measure>
    <time_frame>Up to 6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Influence of anesthetic technique on heart rate during carotid endarterectomy</measure>
    <time_frame>Change of heart rate, from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit</time_frame>
    <description>Change of heart rate, from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit&#xD;
Number of participants: 90 patients&#xD;
Unit of measure: beats per minute (bpm)&#xD;
Heart rate will be measured and compared at the following time points:&#xD;
T0 Baseline (after insertion of an arterial line)&#xD;
T1 After induction of anesthesia, but before surgical start&#xD;
T2 Two minutes after clamping the carotid artery&#xD;
T3 Two minutes after shunt insertation of the carotid artery&#xD;
T4 After reperfusion&#xD;
T5 After completion of the skin suture</description>
  </other_outcome>
  <other_outcome>
    <measure>Influence of anesthetic technique on blood gas analysis during carotid endarterectomy</measure>
    <time_frame>Change of oxygen saturation in blood, from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit</time_frame>
    <description>Number of participants: 90 patients&#xD;
Unit of measure: arterial oxygen tension (PaO2)&#xD;
Blood pressure will be measured and compared at the following time points:&#xD;
T0 Baseline (after insertion of an arterial line)&#xD;
T1 After induction of anesthesia, but before surgical start&#xD;
T2 Two minutes after clamping the carotid artery&#xD;
T3 Two minutes after shunt insertation of the carotid artery&#xD;
T4 After reperfusion&#xD;
T5 After completion of the skin suture</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Carotid Stenosis</condition>
  <arm_group>
    <arm_group_label>Regional anesthesia (RA)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Regional anesthesia (RA) for a carotid endarterectomy Interventions: Regional anesthesia (RA), blood gas analysis, 'Transcranieller Doppler' (Transcranial Doppler ultrasonography), invasive arterial blood pressure measurement, arterial blood gas measurement, neurological control, Near-infrared spectroscopy (NIRS) monitoring, oxygen supply (not invasive 'Vigileo')</description>
  </arm_group>
  <arm_group>
    <arm_group_label>General anesthesia (GA)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>General anesthesia (GA) for a carotid endarterectomy Interventions: General anesthesia, blood gas analysis, 'Transcranieller Doppler' (Transcranial Doppler ultrasonography), invasive arterial blood pressure measurement, arterial blood gas measurement, neurological control, NIRS monitoring, oxygen supply (not invasive 'Vigileo')</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Regional anesthesia</intervention_name>
    <description>Regional anesthesia</description>
    <arm_group_label>Regional anesthesia (RA)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>General anesthesia</intervention_name>
    <description>General anesthesia</description>
    <arm_group_label>General anesthesia (GA)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcranial Doppler ultrasonography</intervention_name>
    <description>6x for 4 hours</description>
    <arm_group_label>General anesthesia (GA)</arm_group_label>
    <arm_group_label>Regional anesthesia (RA)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>blood gas analysis</intervention_name>
    <description>6 x 3 ml blood withdrawal (18 ml) within 4 hours</description>
    <arm_group_label>General anesthesia (GA)</arm_group_label>
    <arm_group_label>Regional anesthesia (RA)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>invasive arterial blood pressure measurement</intervention_name>
    <description>before operation, 8 hours, as done in clinical routine</description>
    <arm_group_label>General anesthesia (GA)</arm_group_label>
    <arm_group_label>Regional anesthesia (RA)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>arterial blood gas measurement</intervention_name>
    <description>perioperative, 4-6 times within 8 hours, as done in clinical routine</description>
    <arm_group_label>General anesthesia (GA)</arm_group_label>
    <arm_group_label>Regional anesthesia (RA)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Neurological Control</intervention_name>
    <description>perioperative, 2-3 days, as done in clinical routine</description>
    <arm_group_label>General anesthesia (GA)</arm_group_label>
    <arm_group_label>Regional anesthesia (RA)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>NIRS monitoring</intervention_name>
    <description>perioperative, for 5 hours, as done in clinical routine</description>
    <arm_group_label>General anesthesia (GA)</arm_group_label>
    <arm_group_label>Regional anesthesia (RA)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>oxygen supply (not invasive 'Vigileo')</intervention_name>
    <description>perioperative for 5 hours, as done in clinical routine</description>
    <arm_group_label>General anesthesia (GA)</arm_group_label>
    <arm_group_label>Regional anesthesia (RA)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age &gt;= 18 years&#xD;
&#xD;
          2. Elective carotid endarterectomy&#xD;
&#xD;
          3. Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age under 18 years&#xD;
&#xD;
          2. Missing signed informed consent&#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>Corinna Velik-Salchner, PrivDoz.Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University Innsbruck</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <state>Tirol</state>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>September 6, 2021</last_update_submitted>
  <last_update_submitted_qc>September 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University Innsbruck</investigator_affiliation>
    <investigator_full_name>Priv.Doz. Dr. Corinna Velik-Salchner</investigator_full_name>
    <investigator_title>Priv.-Doz. Dr.</investigator_title>
  </responsible_party>
  <keyword>carotid endarterectomy</keyword>
  <keyword>cardiac output</keyword>
  <keyword>trans-cranial Doppler</keyword>
  <keyword>CEA</keyword>
  <keyword>regional anesthesia</keyword>
  <keyword>general anesthesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carotid Stenosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02230358
org study id: CODUCE
nct id: NCT02230358
lead sponsor: 
has dmc: No
The aim of this study is to investigate the differences between the cardiac output and the
      cerebral blood-flow between a regional anesthesia (RA) and a general anesthesia (GA) in a
      randomized, controlled, single center study at the Medical University Innsbruck, Department
      of Anesthesia and Intensive Care Medicine.
The investigators will investigate the differences between the cardiac output and the
      cerebral blood-flow between a regional anesthesia (RA) and a general anesthesia (GA) in a
      randomized, controlled, single center study at the Medical University Innsbruck, Department
      of Anesthesia and Intensive Care Medicine.

      For this purpose patients with the need of a carotid endarterectomy (CEA) will be included
      and randomized either to the regional anesthesia (RA) or the general anesthesia (GA) group
      until a patient number of 45 in each group is achieved.

      The cardiac output and cerebral blood-flow via trans-cranial Doppler (TCD) will be measured
      at 6 time points:

        -  T0 Baseline (after insertion of an arterial line)

        -  T1 After induction of anesthesia, but before surgical start

        -  T2 Two minutes after clamping the carotid artery

        -  T3 Two minutes after shunt insertation of the carotid artery

        -  T4 After reperfusion

        -  T5 After completion of the skin suture
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Influence of anesthetic technique on cardiac output during carotid endarterectomy.
time frame: Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit
description: Number of participants: 90 patients
Unit of measure: Cardiac index (l/m2)
Cardiac output will be measured and compared at the following time points:
T0 Baseline (after insertion of an arterial line)
T1 After induction of anesthesia, but before surgical start
T2 Two minutes after clamping the carotid artery
T3 Two minutes after shunt insertation of the carotid artery
T4 After reperfusion
T5 After completion of the skin suture
measure: Influence of anesthetic technique on trans-cranial doppler flow during carotid endarterectomy.
time frame: Change of cardiac output from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit
description: Cerebral blood flow will be measured via trans-cranial Doppler (TCD) and compared at the following time points:
T0 Baseline (after insertion of an arterial line)
T1 After induction of anesthesia, but before surgical start
T2 Two minutes after clamping the carotid artery
T3 Two minutes after shunt insertation of the carotid artery
T4 After reperfusion
T5 After completion of the skin suture
measure: Influence of anesthetic technique on near infrared spectroscopy during carotid endarterectomy.
time frame: Change of cardiac output from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit
description: Number of participants: 90 patients
Unit of measure: blood flow, volume and absolute tissue saturation
Near infrared spectroscopy will be measured and compared at the following time points:
T0 Baseline (after insertion of an arterial line)
T1 After induction of anesthesia, but before surgical start
T2 Two minutes after clamping the carotid artery
T3 Two minutes after shunt insertation of the carotid artery
T4 After reperfusion
T5 After completion of the skin suture
measure: Influence of anesthetic technique on blood pressure during carotid endarterectomy.
time frame: Change of blood pressure, from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit
description: Number of participants: 90 patients
Unit of measure: blood pressure in mmHg
Blood pressure will be measured and compared at the following time points:
T0 Baseline (after insertion of an arterial line)
T1 After induction of anesthesia, but before surgical start
T2 Two minutes after clamping the carotid artery
T3 Two minutes after shunt insertation of the carotid artery
T4 After reperfusion
T5 After completion of the skin suture
measure: Percentage of participants with death.
time frame: Up to 6 months
measure: Number of participants with transient ischemic attack and neck hematoma requiring surgical revision.
time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks
measure: Percentage of participants with myocardial infarction.
time frame: Up to 6 months
measure: Percentage of participants with stroke.
time frame: Up to 6 months
measure: Influence of anesthetic technique on heart rate during carotid endarterectomy
time frame: Change of heart rate, from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit
description: Change of heart rate, from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit
Number of participants: 90 patients
Unit of measure: beats per minute (bpm)
Heart rate will be measured and compared at the following time points:
T0 Baseline (after insertion of an arterial line)
T1 After induction of anesthesia, but before surgical start
T2 Two minutes after clamping the carotid artery
T3 Two minutes after shunt insertation of the carotid artery
T4 After reperfusion
T5 After completion of the skin suture
measure: Influence of anesthetic technique on blood gas analysis during carotid endarterectomy
time frame: Change of oxygen saturation in blood, from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit
description: Number of participants: 90 patients
Unit of measure: arterial oxygen tension (PaO2)
Blood pressure will be measured and compared at the following time points:
T0 Baseline (after insertion of an arterial line)
T1 After induction of anesthesia, but before surgical start
T2 Two minutes after clamping the carotid artery
T3 Two minutes after shunt insertation of the carotid artery
T4 After reperfusion
T5 After completion of the skin suture
arm group label: Regional anesthesia (RA)
arm group type: Other
description: Regional anesthesia (RA) for a carotid endarterectomy Interventions: Regional anesthesia (RA), blood gas analysis, 'Transcranieller Doppler' (Transcranial Doppler ultrasonography), invasive arterial blood pressure measurement, arterial blood gas measurement, neurological control, Near-infrared spectroscopy (NIRS) monitoring, oxygen supply (not invasive 'Vigileo')
arm group label: General anesthesia (GA)
arm group type: Other
description: General anesthesia (GA) for a carotid endarterectomy Interventions: General anesthesia, blood gas analysis, 'Transcranieller Doppler' (Transcranial Doppler ultrasonography), invasive arterial blood pressure measurement, arterial blood gas measurement, neurological control, NIRS monitoring, oxygen supply (not invasive 'Vigileo')
intervention type: Procedure
intervention name: Regional anesthesia
description: Regional anesthesia
arm group label: Regional anesthesia (RA)
intervention type: Procedure
intervention name: General anesthesia
description: General anesthesia
arm group label: General anesthesia (GA)
intervention type: Device
intervention name: Transcranial Doppler ultrasonography
description: 6x for 4 hours
arm group label: General anesthesia (GA)
arm group label: Regional anesthesia (RA)
intervention type: Procedure
intervention name: blood gas analysis
description: 6 x 3 ml blood withdrawal (18 ml) within 4 hours
arm group label: General anesthesia (GA)
arm group label: Regional anesthesia (RA)
intervention type: Procedure
intervention name: invasive arterial blood pressure measurement
description: before operation, 8 hours, as done in clinical routine
arm group label: General anesthesia (GA)
arm group label: Regional anesthesia (RA)
intervention type: Procedure
intervention name: arterial blood gas measurement
description: perioperative, 4-6 times within 8 hours, as done in clinical routine
arm group label: General anesthesia (GA)
arm group label: Regional anesthesia (RA)
intervention type: Behavioral
intervention name: Neurological Control
description: perioperative, 2-3 days, as done in clinical routine
arm group label: General anesthesia (GA)
arm group label: Regional anesthesia (RA)
intervention type: Behavioral
intervention name: NIRS monitoring
description: perioperative, for 5 hours, as done in clinical routine
arm group label: General anesthesia (GA)
arm group label: Regional anesthesia (RA)
intervention type: Device
intervention name: oxygen supply (not invasive 'Vigileo')
description: perioperative for 5 hours, as done in clinical routine
arm group label: General anesthesia (GA)
arm group label: Regional anesthesia (RA)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Corinna Velik-Salchner, PrivDoz.Dr.
role: Principal Investigator
affiliation: Medical University Innsbruck
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University Innsbruck
investigator full name: Priv.Doz. Dr. Corinna Velik-Salchner
investigator title: Priv.-Doz. Dr.
mesh term: Carotid Stenosis
mesh term: Anesthetics