<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/NCT03301571</url>
  </required_header>
  <id_info>
    <org_study_id>17005565</org_study_id>
    <nct_id>NCT03301571</nct_id>
  </id_info>
  <brief_title>Right Ventricular Echocardiography in caRdiac SurgEry</brief_title>
  <acronym>ReVERSE</acronym>
  <official_title>Response in Right Ventricular Function to Change in Afterload, Preload and Inspired Oxygen in Patients Undergoing Coronary Artery Bypass Graft Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Postoperative right ventricular (RV) dysfunction increases mortality and risk of cardiac&#xD;
      failure after cardiac surgery substantially. A comprehensive understanding of this condition&#xD;
      is paramount in order to achieve success in treatment and early diagnosis.&#xD;
&#xD;
      This study has two main aims.&#xD;
&#xD;
      Perioperative aim:&#xD;
&#xD;
      To investigate correlations between changes in echocardiographic measurements and hemodynamic&#xD;
      changes at baseline and following coronary artery bypass graft (CABG) surgery.&#xD;
&#xD;
      Postoperative aim:&#xD;
&#xD;
      To evaluate changes in haemodynamics and echocardiographic parameters during separate&#xD;
      physiological interventions (increase in preload/afterload, oxygen fraction, pacing modes&#xD;
      (AAI/DDD/VVI)).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Clinical procedure:&#xD;
&#xD;
      For the operation standard procedures for anaesthesia, surgery and cardiopulmonary bypass&#xD;
      will be used. This includes installment of a pulmonary artery catheter and performing a&#xD;
      transesophageal echocardiography. For the purpose of this study additional TEE images and a&#xD;
      transthoracic echocardiography (TTE) will be obtained in order to correlate different&#xD;
      echocardiographic indices with haemodynamic measurements and investigate any differences&#xD;
      between TTE and TEE measurements.&#xD;
&#xD;
      Transthoracic echocardiography (TTE):&#xD;
&#xD;
      Basic TTE will be performed after anaesthesia induction, before surgery commences and&#xD;
      repeated immediately after arrival at the ICU.&#xD;
&#xD;
      Image acquisitions from TTE:&#xD;
&#xD;
        -  2D apical 4-chamber view for right ventricular fractional area change (RVFAC)&#xD;
&#xD;
        -  M-mode tricuspid annular plane systolic excursion (TAPSE).&#xD;
&#xD;
        -  M-mode lateral mitral annular plane systolic excursion (MAPSE) measurements&#xD;
&#xD;
      Transoesophageal echocardiography (TEE):&#xD;
&#xD;
      After probe placement and before commencing surgery a TEE will be performed. The probe will&#xD;
      be left in place during surgery for continuous imaging. Standard views used for patient&#xD;
      treatment will be acquired in accordance with the requirements of the treating&#xD;
      anaesthesiologist and surgeon.&#xD;
&#xD;
      Additional views will be added in order to obtain standard 2D measures, M-mode measures,&#xD;
      spectral doppler measures, myocardial doppler tissue imaging, strain and 3D measures of RV&#xD;
      function.&#xD;
&#xD;
      Measurements will be performed at different stages throughout surgery following a period of&#xD;
      relative hemodynamic stability defined as: 1 minute of no more than 10 beats/min variation in&#xD;
      heart rate, maximum variation of 10 mmHg in mean arterial pressure, maximum variation of 3&#xD;
      mmHg in central venous pressure and no change in administration of vasoactive drugs. If&#xD;
      hemodynamic stability cannot be achieved an annotation comment will be entered.&#xD;
&#xD;
      Time points for echocardiography:&#xD;
&#xD;
      TEE will be performed at four different time points during and immediately after surgery:&#xD;
&#xD;
      Stage 1: After induction of anaesthesia. Stage 2: After full sternotomy Stage 3: After&#xD;
      completion of cardiopulmonary bypass Stage 4: Immediately after arrival at the ICU and will&#xD;
      be repeated after each intervention&#xD;
&#xD;
      Interventions Each intervention will be investigated separately and before each intervention&#xD;
      the patient will return to hemodynamic baseline.&#xD;
&#xD;
      Trendelenburg position for 5 minutes will be investigated. Following positive end-expiratory&#xD;
      pressures will be investigated: 0 cm H2O, 5 cm H2O and 10 cm H2O.&#xD;
&#xD;
      Following fractions of inspired O2 will be investigated: 0.5 and 1.0 for 10 minutes at each&#xD;
      setting.&#xD;
&#xD;
      Following pacemaker settings will be investigated: Atrioventricular pacing 10 bpm over the&#xD;
      patients' intrinsic rhythm, atrial pacing 10 bpm over the patients' intrinsic rhythm,&#xD;
      ventricular pacing 10 bpm over the patients' intrinsic rhythm&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 4, 2017</start_date>
  <completion_date type="Actual">October 5, 2017</completion_date>
  <primary_completion_date type="Actual">October 5, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>All patients will receive the same interventions</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in right ventricular function during CABG assessed with TAPSE</measure>
    <time_frame>During a standard CABG operation</time_frame>
    <description>Assessing the change in RV function during CABG surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Right ventricular function assessed with TAPSE after each intervention</measure>
    <time_frame>Immediate postoperative period</time_frame>
    <description>Change in TAPSE after each intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cardiac output measured with Swan-Ganz during CABG</measure>
    <time_frame>During a standard CABG operation</time_frame>
    <description>Cardiac output measured with the thermodilution technique</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cardiac output measured with Swan-Ganz after each intervention</measure>
    <time_frame>Immediate postoperative period</time_frame>
    <description>Cardiac output measured with the thermodilution technique</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response in right ventricular function parameter S' to each intervention</measure>
    <time_frame>Immediate postoperative period</time_frame>
    <description>Change in S'</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response in right ventricular function parameter S' during CABG</measure>
    <time_frame>During a standard CABG operation</time_frame>
    <description>Change in S'</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response in right ventricular function parameter Tei index to each intervention</measure>
    <time_frame>Immediate postoperative period</time_frame>
    <description>Change in Tei index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response in right ventricular function parameter Tei index during a standard CABG operation</measure>
    <time_frame>During a standard CABG operation</time_frame>
    <description>Change in Tei index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response in right ventricular function parameter RVFAC to each intervention</measure>
    <time_frame>Immediate postoperative period</time_frame>
    <description>Change in RVFAC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response in right ventricular function parameter RVFAC during a standard CABG operation</measure>
    <time_frame>During a standard CABG operation</time_frame>
    <description>Change in RVFAC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response in left ventricular function parameter MAPSE to each intervention</measure>
    <time_frame>Immediate postoperative period</time_frame>
    <description>Change in MAPSE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response in left ventricular function parameter MAPSE during a standard CABG operation</measure>
    <time_frame>During a standard CABG operation</time_frame>
    <description>Change in MAPSE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response in right ventricular function parameter strain % to each intervention</measure>
    <time_frame>Immediate postoperative period</time_frame>
    <description>Change in strain %</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response in right ventricular function parameter strain % during a standard CABG operation</measure>
    <time_frame>During a standard CABG operation</time_frame>
    <description>Change in strain %</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response in right ventricular function parameter strain rate to each intervention</measure>
    <time_frame>Immediate postoperative period</time_frame>
    <description>Change in strain rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response in right ventricular function parameter strain rate during a standard CABG operation</measure>
    <time_frame>During a standard CABG operation</time_frame>
    <description>Change in strain rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response in right ventricular function parameter RV size to each intervention</measure>
    <time_frame>Immediate postoperative period</time_frame>
    <description>Change in RV size</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response in right ventricular function parameter RV size during a standard CABG operation</measure>
    <time_frame>During a standard CABG operation</time_frame>
    <description>Change in RV size</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response in right ventricular function parameter pulmonary artery flow velocity to each intervention</measure>
    <time_frame>Immediate postoperative period</time_frame>
    <description>Change in flow velocity in pulmonary artery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response in right ventricular function parameter pulmonary artery flow velocity during a standard CABG operation</measure>
    <time_frame>During a standard CABG operation</time_frame>
    <description>Change in flow velocity in pulmonary artery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response in right ventricular function parameter RVEF to each intervention</measure>
    <time_frame>Immediate postoperative period</time_frame>
    <description>Change in RVEF measured with 3D echo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response in right ventricular function parameter RVEF during a standard CABG operation</measure>
    <time_frame>During a standard CABG operation</time_frame>
    <description>Change in RVEF measured with 3D echo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response in right ventricular function parameter RVEF during CABG</measure>
    <time_frame>Immediate postoperative period</time_frame>
    <description>Change in RVEF measured with 3D echo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cardiac output measured with Swan Ganz in response during a standard CABG operation</measure>
    <time_frame>During a standard CABG operation</time_frame>
    <description>Following each intervention in the postoperative period cardiac output will be measured with the thermodilution technique.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cardiac output measured with Swan Ganz in response to each intervention</measure>
    <time_frame>Immediate postoperative period</time_frame>
    <description>Following each intervention in the postoperative period cardiac output will be measured with the thermodilution technique.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in hemodynamic pressures in response to each intervention</measure>
    <time_frame>Immediate postoperative period</time_frame>
    <description>Following each intervention in the postoperative period hemodynamic pressures will be measured with the Swan Ganz catheter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in hemodynamic pressures during a standard CABG operation</measure>
    <time_frame>During a standard CABG operation</time_frame>
    <description>Following each intervention in the postoperative period hemodynamic pressures will be measured with the Swan Ganz catheter</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Right Ventricular Dysfunction</condition>
  <arm_group>
    <arm_group_label>All patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All patients will receive the treatment (CABG) and postoperatively three different interventions:&#xD;
Change in preload and afterload&#xD;
Change in inspired oxygen&#xD;
Change in pacemaker modes</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Change in preload and afterload</intervention_name>
    <description>Afterload: Three levels of positive end-expiratory pressure (PEEP) will be examined post-operatively: 0 cm H20, 5 cm H2O, 10 cm H2O Preload: Trendelenburg position for 5 minutes will be investigated</description>
    <arm_group_label>All patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Inspired oxygen</intervention_name>
    <description>Following fractions of inspired O2 will be investigated: 0.5 and 1.0 for 10 minutes respectively</description>
    <arm_group_label>All patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pacemaker mode</intervention_name>
    <description>Following pacemaker settings will be investigated: Atrioventricular pacing 10 bpm over the patients' intrinsic rhythm, atrial pacing 10 bpm over the patients' intrinsic rhythm, ventricular pacing 10 bpm over the patients' intrinsic rhythm</description>
    <arm_group_label>All patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elective coronary artery bypass graft patients&#xD;
&#xD;
          -  Normal left ventricular function defined as LVEF over 50 % on TTE preoperatively&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-existing right ventricular malformations&#xD;
&#xD;
          -  Severe right ventricular impairment preoperatively&#xD;
&#xD;
          -  Pre-existing non-sinus rhythm&#xD;
&#xD;
          -  Pre-existing mitral valve stenosis or severe regurgitation&#xD;
&#xD;
          -  Pre-existing pulmonary hypertension&#xD;
&#xD;
          -  Pre-existing tricuspid valve stenosis or severe regurgitation&#xD;
&#xD;
          -  Patients with contraindication to TEE probe placement such as oesophageal stricture or&#xD;
             obstruction&#xD;
&#xD;
          -  Patients with contraindication to Swan-Ganz catheter placement&#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>Lars Grønlykke, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rigshospitalet, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <state>Capital Region</state>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>January 8, 2018</last_update_submitted>
  <last_update_submitted_qc>January 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Lars Grønlykke</investigator_full_name>
    <investigator_title>Principal investigator, MD</investigator_title>
  </responsible_party>
  <keyword>Coronary artery bypass graft</keyword>
  <keyword>Echocardiography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ventricular Dysfunction</mesh_term>
    <mesh_term>Ventricular Dysfunction, Right</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03301571
org study id: 17005565
nct id: NCT03301571
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Postoperative right ventricular (RV) dysfunction increases mortality and risk of cardiac
      failure after cardiac surgery substantially. A comprehensive understanding of this condition
      is paramount in order to achieve success in treatment and early diagnosis.

      This study has two main aims.

      Perioperative aim:

      To investigate correlations between changes in echocardiographic measurements and hemodynamic
      changes at baseline and following coronary artery bypass graft (CABG) surgery.

      Postoperative aim:

      To evaluate changes in haemodynamics and echocardiographic parameters during separate
      physiological interventions (increase in preload/afterload, oxygen fraction, pacing modes
      (AAI/DDD/VVI)).
Clinical procedure:

      For the operation standard procedures for anaesthesia, surgery and cardiopulmonary bypass
      will be used. This includes installment of a pulmonary artery catheter and performing a
      transesophageal echocardiography. For the purpose of this study additional TEE images and a
      transthoracic echocardiography (TTE) will be obtained in order to correlate different
      echocardiographic indices with haemodynamic measurements and investigate any differences
      between TTE and TEE measurements.

      Transthoracic echocardiography (TTE):

      Basic TTE will be performed after anaesthesia induction, before surgery commences and
      repeated immediately after arrival at the ICU.

      Image acquisitions from TTE:

        -  2D apical 4-chamber view for right ventricular fractional area change (RVFAC)

        -  M-mode tricuspid annular plane systolic excursion (TAPSE).

        -  M-mode lateral mitral annular plane systolic excursion (MAPSE) measurements

      Transoesophageal echocardiography (TEE):

      After probe placement and before commencing surgery a TEE will be performed. The probe will
      be left in place during surgery for continuous imaging. Standard views used for patient
      treatment will be acquired in accordance with the requirements of the treating
      anaesthesiologist and surgeon.

      Additional views will be added in order to obtain standard 2D measures, M-mode measures,
      spectral doppler measures, myocardial doppler tissue imaging, strain and 3D measures of RV
      function.

      Measurements will be performed at different stages throughout surgery following a period of
      relative hemodynamic stability defined as: 1 minute of no more than 10 beats/min variation in
      heart rate, maximum variation of 10 mmHg in mean arterial pressure, maximum variation of 3
      mmHg in central venous pressure and no change in administration of vasoactive drugs. If
      hemodynamic stability cannot be achieved an annotation comment will be entered.

      Time points for echocardiography:

      TEE will be performed at four different time points during and immediately after surgery:

      Stage 1: After induction of anaesthesia. Stage 2: After full sternotomy Stage 3: After
      completion of cardiopulmonary bypass Stage 4: Immediately after arrival at the ICU and will
      be repeated after each intervention

      Interventions Each intervention will be investigated separately and before each intervention
      the patient will return to hemodynamic baseline.

      Trendelenburg position for 5 minutes will be investigated. Following positive end-expiratory
      pressures will be investigated: 0 cm H2O, 5 cm H2O and 10 cm H2O.

      Following fractions of inspired O2 will be investigated: 0.5 and 1.0 for 10 minutes at each
      setting.

      Following pacemaker settings will be investigated: Atrioventricular pacing 10 bpm over the
      patients' intrinsic rhythm, atrial pacing 10 bpm over the patients' intrinsic rhythm,
      ventricular pacing 10 bpm over the patients' intrinsic rhythm
allocation: N/A
intervention model: Single Group Assignment
intervention model description: All patients will receive the same interventions
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in right ventricular function during CABG assessed with TAPSE
time frame: During a standard CABG operation
description: Assessing the change in RV function during CABG surgery
measure: Right ventricular function assessed with TAPSE after each intervention
time frame: Immediate postoperative period
description: Change in TAPSE after each intervention
measure: Change in cardiac output measured with Swan-Ganz during CABG
time frame: During a standard CABG operation
description: Cardiac output measured with the thermodilution technique
measure: Change in cardiac output measured with Swan-Ganz after each intervention
time frame: Immediate postoperative period
description: Cardiac output measured with the thermodilution technique
measure: Response in right ventricular function parameter S' to each intervention
time frame: Immediate postoperative period
description: Change in S'
measure: Response in right ventricular function parameter S' during CABG
time frame: During a standard CABG operation
description: Change in S'
measure: Response in right ventricular function parameter Tei index to each intervention
time frame: Immediate postoperative period
description: Change in Tei index
measure: Response in right ventricular function parameter Tei index during a standard CABG operation
time frame: During a standard CABG operation
description: Change in Tei index
measure: Response in right ventricular function parameter RVFAC to each intervention
time frame: Immediate postoperative period
description: Change in RVFAC
measure: Response in right ventricular function parameter RVFAC during a standard CABG operation
time frame: During a standard CABG operation
description: Change in RVFAC
measure: Response in left ventricular function parameter MAPSE to each intervention
time frame: Immediate postoperative period
description: Change in MAPSE
measure: Response in left ventricular function parameter MAPSE during a standard CABG operation
time frame: During a standard CABG operation
description: Change in MAPSE
measure: Response in right ventricular function parameter strain % to each intervention
time frame: Immediate postoperative period
description: Change in strain %
measure: Response in right ventricular function parameter strain % during a standard CABG operation
time frame: During a standard CABG operation
description: Change in strain %
measure: Response in right ventricular function parameter strain rate to each intervention
time frame: Immediate postoperative period
description: Change in strain rate
measure: Response in right ventricular function parameter strain rate during a standard CABG operation
time frame: During a standard CABG operation
description: Change in strain rate
measure: Response in right ventricular function parameter RV size to each intervention
time frame: Immediate postoperative period
description: Change in RV size
measure: Response in right ventricular function parameter RV size during a standard CABG operation
time frame: During a standard CABG operation
description: Change in RV size
measure: Response in right ventricular function parameter pulmonary artery flow velocity to each intervention
time frame: Immediate postoperative period
description: Change in flow velocity in pulmonary artery
measure: Response in right ventricular function parameter pulmonary artery flow velocity during a standard CABG operation
time frame: During a standard CABG operation
description: Change in flow velocity in pulmonary artery
measure: Response in right ventricular function parameter RVEF to each intervention
time frame: Immediate postoperative period
description: Change in RVEF measured with 3D echo
measure: Response in right ventricular function parameter RVEF during a standard CABG operation
time frame: During a standard CABG operation
description: Change in RVEF measured with 3D echo
measure: Response in right ventricular function parameter RVEF during CABG
time frame: Immediate postoperative period
description: Change in RVEF measured with 3D echo
measure: Change in cardiac output measured with Swan Ganz in response during a standard CABG operation
time frame: During a standard CABG operation
description: Following each intervention in the postoperative period cardiac output will be measured with the thermodilution technique.
measure: Change in cardiac output measured with Swan Ganz in response to each intervention
time frame: Immediate postoperative period
description: Following each intervention in the postoperative period cardiac output will be measured with the thermodilution technique.
measure: Change in hemodynamic pressures in response to each intervention
time frame: Immediate postoperative period
description: Following each intervention in the postoperative period hemodynamic pressures will be measured with the Swan Ganz catheter
measure: Change in hemodynamic pressures during a standard CABG operation
time frame: During a standard CABG operation
description: Following each intervention in the postoperative period hemodynamic pressures will be measured with the Swan Ganz catheter
arm group label: All patients
arm group type: Other
description: All patients will receive the treatment (CABG) and postoperatively three different interventions:
Change in preload and afterload
Change in inspired oxygen
Change in pacemaker modes
intervention type: Other
intervention name: Change in preload and afterload
description: Afterload: Three levels of positive end-expiratory pressure (PEEP) will be examined post-operatively: 0 cm H20, 5 cm H2O, 10 cm H2O Preload: Trendelenburg position for 5 minutes will be investigated
arm group label: All patients
intervention type: Other
intervention name: Inspired oxygen
description: Following fractions of inspired O2 will be investigated: 0.5 and 1.0 for 10 minutes respectively
arm group label: All patients
intervention type: Other
intervention name: Pacemaker mode
description: Following pacemaker settings will be investigated: Atrioventricular pacing 10 bpm over the patients' intrinsic rhythm, atrial pacing 10 bpm over the patients' intrinsic rhythm, ventricular pacing 10 bpm over the patients' intrinsic rhythm
arm group label: All patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lars Grønlykke, MD
role: Principal Investigator
affiliation: Rigshospitalet, Denmark
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Lars Grønlykke
investigator title: Principal investigator, MD
mesh term: Ventricular Dysfunction
mesh term: Ventricular Dysfunction, Right
sharing ipd: No