<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/NCT04424433</url>
  </required_header>
  <id_info>
    <org_study_id>2020-00145</org_study_id>
    <secondary_id>SNCTP000003911</secondary_id>
    <nct_id>NCT04424433</nct_id>
  </id_info>
  <brief_title>Myocardial Strain Analysis in Anaesthetized Coronary Artery Disease Patients During Hyperoxia and Normoxaemia</brief_title>
  <acronym>Strecho-O₂</acronym>
  <official_title>Myocardial Strain Analysis in Patients With Coronary Artery Disease at Hyperoxia and Normoxaemia Prior to Coronary Artery Bypass Graft Surgery - a Randomized Crossover Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Insel Gruppe AG, University Hospital Bern</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>
      The purpose of this study is to investigate the impact of supraphysiologic oxygen (hyperoxia)&#xD;
      on myocardial function in anaesthetized patients with coronary artery disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Up to 106 patients with coronary artery disease undergoing elective coronary artery bypass&#xD;
      graft (CABG) surgery will be recruited to undergo this single visit study. In the timeframe&#xD;
      shortly after the induction of anaesthesia and prior to the start of surgery, myocardial&#xD;
      strain as a marker of cardiac function will be measured by transesophageal echocardiography&#xD;
      (TEE). Echocardiography measurements will be acquired at two different oxygen states for each&#xD;
      patient. The fraction of inspired oxygen (FiO2) will be adjusted to reach a normoxaemic state&#xD;
      (FiO2=0.3) and a hyperoxic state (FiO2=0.8). Patients will be randomized to which oxygen&#xD;
      level is investigated first. Thereafter, the study intervention is completed and anaesthesia&#xD;
      and surgery will be performed as planned by the treating team. Echocardiography images will&#xD;
      be analyzed in a blinded manner for cardiac function and systolic and diastolic strain&#xD;
      parameters. The results will help anaesthesiologists to better weigh risks and benefits when&#xD;
      selecting an inspired oxygen fraction in such patients, and will help to evaluate hyperoxia&#xD;
      as a risk factor for myocardial injury.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">June 4, 2021</completion_date>
  <primary_completion_date type="Actual">June 4, 2021</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>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>TEE images will be coded and analysed in batches at a later date by a blinded reader</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in myocardial peak strain between oxygen levels</measure>
    <time_frame>Through study completion, within 1hour post-induction</time_frame>
    <description>Percent (%), a measure of systolic function (shortening and thickening) of the myocardium</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in myocardial time to peak strain between oxygen levels</measure>
    <time_frame>Through study completion, within 1hour post-induction</time_frame>
    <description>Milliseconds (ms)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in myocardial strain rate between oxygen levels</measure>
    <time_frame>Through study completion, within 1hour post-induction</time_frame>
    <description>Change in strain over time (/second)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in myocardial strain rate ratio between oxygen levels</measure>
    <time_frame>Through study completion, within 1hour post-induction</time_frame>
    <description>Change in E/A ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in myocardial displacement between oxygen levels</measure>
    <time_frame>Through study completion, within 1hour post-induction</time_frame>
    <description>Millimeters (mm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in myocardial time to peak displacement between oxygen levels</measure>
    <time_frame>Through study completion, within 1hour post-induction</time_frame>
    <description>Milliseconds (ms)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in myocardial velocities between oxygen levels</measure>
    <time_frame>Through study completion, within 1hour post-induction</time_frame>
    <description>Change in displacement over time (millimeters/second)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in myocardial velocity ratio between oxygen levels</measure>
    <time_frame>Through study completion, within 1hour post-induction</time_frame>
    <description>Change in E/A ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in peak twist</measure>
    <time_frame>Through study completion, within 1hour post-induction</time_frame>
    <description>Degrees (°)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in peak torsion</measure>
    <time_frame>Through study completion, within 1hour post-induction</time_frame>
    <description>Degrees/centimeter (°/cm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in ejection fraction (EF)</measure>
    <time_frame>Through study completion, within 1hour post-induction</time_frame>
    <description>Percent (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in chamber volumes</measure>
    <time_frame>Through study completion, within 1hour post-induction</time_frame>
    <description>Millilitres (ml)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">106</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Normoxaemia First</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients will undergo TEE imaging at normoxaemia (FiO2=0.3) first, and hyperoxia (FiO2=0.8) will be targeted second.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hyperoxia First</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients will undergo TEE imaging at hyperoxia (FiO2=0.8) first, and normoxaemia (FiO2=0.3) will be targeted second.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxygen</intervention_name>
    <description>Two FIO2 settings during stable general anaesthesia resulting in normoxaemic and hyperoxic arterial oxygen partial pressures.</description>
    <arm_group_label>Hyperoxia First</arm_group_label>
    <arm_group_label>Normoxaemia First</arm_group_label>
    <other_name>Medical gas</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elective CABG surgery (with or without other cardiac surgery)&#xD;
&#xD;
          -  Ability to give and sign informed consent&#xD;
&#xD;
          -  Age &gt;18 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Absolute contraindication for TEE&#xD;
&#xD;
          -  Emergency surgery, including but not limited to patients with instable CAD: ST- and&#xD;
             Non-ST-elevation myocardial infarction (STEMI, NSTEMI) and instable angina (instable&#xD;
             AP)&#xD;
&#xD;
          -  Atrial fibrillation or significant arrhythmia&#xD;
&#xD;
          -  Pacemaker, CRT, left bundle branch block&#xD;
&#xD;
          -  Severe-grade valvular disease&#xD;
&#xD;
          -  Pericardial disease&#xD;
&#xD;
          -  Previous cardiac or thoracic aortic surgery&#xD;
&#xD;
          -  Previous chest radiation therapy or cardiotoxic or bleomycin chemotherapy&#xD;
&#xD;
          -  Severe pulmonary hypertension, cor-pulmonale, or right ventricular dysfunction, i.e.,&#xD;
             where high FIO2 might reduce pulmonary vascular resistance and right ventricular&#xD;
             afterload&#xD;
&#xD;
          -  Patients where study explanation and informed consent cannot been performed/obtained&#xD;
             at the latest on the day before scheduled surgery&#xD;
&#xD;
          -  Females of child-bearing potential&#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>Dominik P Guensch, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bern University Hospital, Inselspital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bern University Hospital, Inselspital</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>Guensch DP, Fischer K, Yamaji K, Luescher S, Ueki Y, Jung B, Erdoes G, Grani C, von Tengg-Kobligk H, Raber L, Eberle B. Effect of Hyperoxia on Myocardial Oxygenation and Function in Patients With Stable Multivessel Coronary Artery Disease. J Am Heart Assoc. 2020 Mar 3;9(5):e014739. doi: 10.1161/JAHA.119.014739. Epub 2020 Feb 22.</citation>
    <PMID>32089047</PMID>
  </reference>
  <reference>
    <citation>Guensch DP, Fischer K, Shie N, Lebel J, Friedrich MG. Hyperoxia Exacerbates Myocardial Ischemia in the Presence of Acute Coronary Artery Stenosis in Swine. Circ Cardiovasc Interv. 2015 Oct;8(10):e002928. doi: 10.1161/CIRCINTERVENTIONS.115.002928.</citation>
    <PMID>26405156</PMID>
  </reference>
  <reference>
    <citation>Guensch DP, Friess JO, Eberle B, Erdoes G. Hyperoxia-a Wolf in Sheep's Clothing? J Cardiothorac Vasc Anesth. 2019 May;33(5):1179-1180. doi: 10.1053/j.jvca.2018.12.024. Epub 2018 Dec 27. No abstract available.</citation>
    <PMID>30685156</PMID>
  </reference>
  <reference>
    <citation>de Jonge S, Egger M, Latif A, Loke YK, Berenholtz S, Boermeester M, Allegranzi B, Solomkin J. Effectiveness of 80% vs 30-35% fraction of inspired oxygen in patients undergoing surgery: an updated systematic review and meta-analysis. Br J Anaesth. 2019 Mar;122(3):325-334. doi: 10.1016/j.bja.2018.11.024. Epub 2019 Jan 6.</citation>
    <PMID>30770050</PMID>
  </reference>
  <reference>
    <citation>Morkane CM, McKenna H, Cumpstey AF, Oldman AH, Grocott MPW, Martin DS; Pan London Perioperative Audit and Research Network (PLAN); South Coast Perioperative Audit and Research Collaboration (SPARC). Intraoperative oxygenation in adult patients undergoing surgery (iOPS): a retrospective observational study across 29 UK hospitals. Perioper Med (Lond). 2018 Jul 24;7:17. doi: 10.1186/s13741-018-0098-3. eCollection 2018. Erratum In: Perioper Med (Lond). 2018 Oct 24;7:26. South Coast Perioperative Audit and Research Collaboration (SPARC) [added].</citation>
    <PMID>30062007</PMID>
  </reference>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 8, 2021</last_update_submitted>
  <last_update_submitted_qc>June 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Coronary artery disease</keyword>
  <keyword>Transesophageal Echocardiography (TEE)</keyword>
  <keyword>Hyperoxia</keyword>
  <keyword>Strain</keyword>
  <keyword>Myocardial Deformation</keyword>
  <keyword>Anaesthesia</keyword>
  <keyword>CABG</keyword>
  <keyword>Normoxaemia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Hyperoxia</mesh_term>
  </condition_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/NCT04424433
org study id: 2020-00145
secondary id: SNCTP000003911
nct id: NCT04424433
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate the impact of supraphysiologic oxygen (hyperoxia)
      on myocardial function in anaesthetized patients with coronary artery disease.
Up to 106 patients with coronary artery disease undergoing elective coronary artery bypass
      graft (CABG) surgery will be recruited to undergo this single visit study. In the timeframe
      shortly after the induction of anaesthesia and prior to the start of surgery, myocardial
      strain as a marker of cardiac function will be measured by transesophageal echocardiography
      (TEE). Echocardiography measurements will be acquired at two different oxygen states for each
      patient. The fraction of inspired oxygen (FiO2) will be adjusted to reach a normoxaemic state
      (FiO2=0.3) and a hyperoxic state (FiO2=0.8). Patients will be randomized to which oxygen
      level is investigated first. Thereafter, the study intervention is completed and anaesthesia
      and surgery will be performed as planned by the treating team. Echocardiography images will
      be analyzed in a blinded manner for cardiac function and systolic and diastolic strain
      parameters. The results will help anaesthesiologists to better weigh risks and benefits when
      selecting an inspired oxygen fraction in such patients, and will help to evaluate hyperoxia
      as a risk factor for myocardial injury.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
masking description: TEE images will be coded and analysed in batches at a later date by a blinded reader
measure: Difference in myocardial peak strain between oxygen levels
time frame: Through study completion, within 1hour post-induction
description: Percent (%), a measure of systolic function (shortening and thickening) of the myocardium
measure: Difference in myocardial time to peak strain between oxygen levels
time frame: Through study completion, within 1hour post-induction
description: Milliseconds (ms)
measure: Difference in myocardial strain rate between oxygen levels
time frame: Through study completion, within 1hour post-induction
description: Change in strain over time (/second)
measure: Difference in myocardial strain rate ratio between oxygen levels
time frame: Through study completion, within 1hour post-induction
description: Change in E/A ratio
measure: Difference in myocardial displacement between oxygen levels
time frame: Through study completion, within 1hour post-induction
description: Millimeters (mm)
measure: Difference in myocardial time to peak displacement between oxygen levels
time frame: Through study completion, within 1hour post-induction
description: Milliseconds (ms)
measure: Difference in myocardial velocities between oxygen levels
time frame: Through study completion, within 1hour post-induction
description: Change in displacement over time (millimeters/second)
measure: Difference in myocardial velocity ratio between oxygen levels
time frame: Through study completion, within 1hour post-induction
description: Change in E/A ratio
measure: Difference in peak twist
time frame: Through study completion, within 1hour post-induction
description: Degrees (°)
measure: Difference in peak torsion
time frame: Through study completion, within 1hour post-induction
description: Degrees/centimeter (°/cm)
measure: Difference in ejection fraction (EF)
time frame: Through study completion, within 1hour post-induction
description: Percent (%)
measure: Difference in chamber volumes
time frame: Through study completion, within 1hour post-induction
description: Millilitres (ml)
arm group label: Normoxaemia First
arm group type: Other
description: Patients will undergo TEE imaging at normoxaemia (FiO2=0.3) first, and hyperoxia (FiO2=0.8) will be targeted second.
arm group label: Hyperoxia First
arm group type: Other
description: Patients will undergo TEE imaging at hyperoxia (FiO2=0.8) first, and normoxaemia (FiO2=0.3) will be targeted second.
intervention type: Drug
intervention name: Oxygen
description: Two FIO2 settings during stable general anaesthesia resulting in normoxaemic and hyperoxic arterial oxygen partial pressures.
arm group label: Hyperoxia First
arm group label: Normoxaemia First
other name: Medical gas
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dominik P Guensch, MD
role: Principal Investigator
affiliation: Bern University Hospital, Inselspital
facility: 
country: Switzerland
citation: Guensch DP, Fischer K, Yamaji K, Luescher S, Ueki Y, Jung B, Erdoes G, Grani C, von Tengg-Kobligk H, Raber L, Eberle B. Effect of Hyperoxia on Myocardial Oxygenation and Function in Patients With Stable Multivessel Coronary Artery Disease. J Am Heart Assoc. 2020 Mar 3;9(5):e014739. doi: 10.1161/JAHA.119.014739. Epub 2020 Feb 22.
PMID: 32089047
citation: Guensch DP, Fischer K, Shie N, Lebel J, Friedrich MG. Hyperoxia Exacerbates Myocardial Ischemia in the Presence of Acute Coronary Artery Stenosis in Swine. Circ Cardiovasc Interv. 2015 Oct;8(10):e002928. doi: 10.1161/CIRCINTERVENTIONS.115.002928.
PMID: 26405156
citation: Guensch DP, Friess JO, Eberle B, Erdoes G. Hyperoxia-a Wolf in Sheep's Clothing? J Cardiothorac Vasc Anesth. 2019 May;33(5):1179-1180. doi: 10.1053/j.jvca.2018.12.024. Epub 2018 Dec 27. No abstract available.
PMID: 30685156
citation: de Jonge S, Egger M, Latif A, Loke YK, Berenholtz S, Boermeester M, Allegranzi B, Solomkin J. Effectiveness of 80% vs 30-35% fraction of inspired oxygen in patients undergoing surgery: an updated systematic review and meta-analysis. Br J Anaesth. 2019 Mar;122(3):325-334. doi: 10.1016/j.bja.2018.11.024. Epub 2019 Jan 6.
PMID: 30770050
citation: Morkane CM, McKenna H, Cumpstey AF, Oldman AH, Grocott MPW, Martin DS; Pan London Perioperative Audit and Research Network (PLAN); South Coast Perioperative Audit and Research Collaboration (SPARC). Intraoperative oxygenation in adult patients undergoing surgery (iOPS): a retrospective observational study across 29 UK hospitals. Perioper Med (Lond). 2018 Jul 24;7:17. doi: 10.1186/s13741-018-0098-3. eCollection 2018. Erratum In: Perioper Med (Lond). 2018 Oct 24;7:26. South Coast Perioperative Audit and Research Collaboration (SPARC) [added].
PMID: 30062007
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
mesh term: Hyperoxia