<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/NCT01673841</url>
  </required_header>
  <id_info>
    <org_study_id>2009/126</org_study_id>
    <nct_id>NCT01673841</nct_id>
  </id_info>
  <brief_title>Relation Between Mixed Venous Oxygen Saturation and Cerebral Oxygen Saturation Measured by Absolute and Relative Near-infrared Spectroscopy During Off-pump Coronary Artery Bypass Grafting.</brief_title>
  <official_title>Relation Between Mixed Venous Oxygen Saturation and Cerebral Oxygen Saturation Measured by Absolute and Relative Near-infrared Spectroscopy During Off-pump Coronary Artery Bypass Grafting.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Belgian Foundation for Cardiac Surgery</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>CAS Medical Systems, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Ghent</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this clinical study the investigators compared mixed venous oxygen saturation (SmvO2) with&#xD;
      relative and absolute cerebral oxygen saturation (rScO2) measurements. They hypothesized that&#xD;
      previously reported contradictory results regarding the equivalence of SmvO2 and rScO2 might&#xD;
      be related to time delay issues and to the measurement technology.&#xD;
&#xD;
      42 consenting patients undergoing elective off-pump coronary artery bypass grafting were&#xD;
      included. 4 disposable oxygenation sensors were applied bilaterally on the patient's forehead&#xD;
      for continuous, non-invasive registration of rScO2. The sensors of one monitor were placed&#xD;
      just above the eyebrows, and the sensors of the other monitor were placed just above the&#xD;
      former sensors. The sensors placement was determined at random by a computerized&#xD;
      randomization list. SmvO2 was measured continuously via a pulmonary artery catheter. All&#xD;
      variables were recorded continuously. The study ended at the end of the operation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2009</start_date>
  <completion_date type="Actual">June 2011</completion_date>
  <primary_completion_date type="Actual">June 2011</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>Correlation and time delay between mixed venous and cerebral oxygen saturation during off-pump coronary artery bypass grafting.</measure>
    <time_frame>4 hours during an operation of average 5 hours (during off-pump coronary artery bypass grafting).</time_frame>
    <description>Mixed venous oxygen saturation was measured continuously via a pulmonary artery catheter. Cerebral oxygen saturation was measured with near-infrared spectroscopy; the INVOS monitor to obtain relative measurements, and the Foresight monitor to obtain absolute data.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The response of cerebral oxygen saturation to major haemodynamic disturbances.</measure>
    <time_frame>2 hours after start of operation (during placement of deep pericardial stitches).</time_frame>
    <description>Percentage difference between the cerebral oxygen saturation value just before heart retraction and the value at the different time moments.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">42</enrollment>
  <condition>Elective Off-pump Coronary Artery Bypass Grafting</condition>
  <arm_group>
    <arm_group_label>Relative + absolute cerebral oxygen saturation.</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Relative and absolute cerebral oxygen saturation (rScO2) measurements.</intervention_name>
    <arm_group_label>Relative + absolute cerebral oxygen saturation.</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing elective off-pump coronary artery bypass grafting.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing elective off-pump coronary artery bypass grafting for at least&#xD;
             3-vessel coronary artery disease were eligible.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with arteriovenous shunts, intracardiac shunts, a previous history of&#xD;
             cerebrovascular accident, or stenosis of the internal carotid artery of &gt; 60% were&#xD;
             excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Annelies Moerman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Ghent</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ghent University Hospital</name>
      <address>
        <city>Ghent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <link>
    <url>http://www.uzgent.be</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>August 17, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>July 7, 2021</last_update_submitted>
  <last_update_submitted_qc>July 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bypass grafting</keyword>
  <!-- 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/NCT01673841
org study id: 2009/126
nct id: NCT01673841
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
In this clinical study the investigators compared mixed venous oxygen saturation (SmvO2) with
      relative and absolute cerebral oxygen saturation (rScO2) measurements. They hypothesized that
      previously reported contradictory results regarding the equivalence of SmvO2 and rScO2 might
      be related to time delay issues and to the measurement technology.

      42 consenting patients undergoing elective off-pump coronary artery bypass grafting were
      included. 4 disposable oxygenation sensors were applied bilaterally on the patient's forehead
      for continuous, non-invasive registration of rScO2. The sensors of one monitor were placed
      just above the eyebrows, and the sensors of the other monitor were placed just above the
      former sensors. The sensors placement was determined at random by a computerized
      randomization list. SmvO2 was measured continuously via a pulmonary artery catheter. All
      variables were recorded continuously. The study ended at the end of the operation.
observational model: Case-Only
time perspective: Prospective
measure: Correlation and time delay between mixed venous and cerebral oxygen saturation during off-pump coronary artery bypass grafting.
time frame: 4 hours during an operation of average 5 hours (during off-pump coronary artery bypass grafting).
description: Mixed venous oxygen saturation was measured continuously via a pulmonary artery catheter. Cerebral oxygen saturation was measured with near-infrared spectroscopy; the INVOS monitor to obtain relative measurements, and the Foresight monitor to obtain absolute data.
measure: The response of cerebral oxygen saturation to major haemodynamic disturbances.
time frame: 2 hours after start of operation (during placement of deep pericardial stitches).
description: Percentage difference between the cerebral oxygen saturation value just before heart retraction and the value at the different time moments.
arm group label: Relative + absolute cerebral oxygen saturation.
intervention type: Procedure
intervention name: Relative and absolute cerebral oxygen saturation (rScO2) measurements.
arm group label: Relative + absolute cerebral oxygen saturation.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 25 Years
maximum age: 100 Years
healthy volunteers: No
last name: Annelies Moerman, MD
role: Principal Investigator
affiliation: University Hospital, Ghent
facility: 
country: Belgium
url: http://www.uzgent.be
description: Related Info
responsible party type: Sponsor