<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/NCT03291210</url>
  </required_header>
  <id_info>
    <org_study_id>TAVI-O2</org_study_id>
    <nct_id>NCT03291210</nct_id>
  </id_info>
  <brief_title>O2 Tension During TAVI</brief_title>
  <official_title>Effect of O2 Tension on Myocardial Injury During TAVI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Hyperoxemia can produce various complications including oxidative stress and myocardial&#xD;
      injury. We hypothesized that the normoxic group would have lower myocardial injury compared&#xD;
      to hyperoxic group after transcatheter aortic valve replacement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hyperoxemia can produce various complications, such as excessive oxidative stress,&#xD;
      hyperoxia-induced vasoconstriction, increased perfusion heterogeneity, and resultant&#xD;
      myocardial injury. Previous studies have been observed higher mortality in patient group&#xD;
      maintained with supranormal oxygenation after resuscitation from cardiac arrest. However, the&#xD;
      effect of hyperoxia vs. normoxia on myocardial injury during transcatheter aortic valve&#xD;
      replacement (TAVR) has not been well investigated. We hypothesized that the normoxic group&#xD;
      would have lower myocardial injury compared to hyperoxic group after TAVR.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 18, 2017</start_date>
  <completion_date type="Actual">July 18, 2022</completion_date>
  <primary_completion_date type="Actual">April 6, 2022</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Troponin I</measure>
    <time_frame>72 hours after the end of procedure</time_frame>
    <description>Area under the curve of troponin I</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CK MB</measure>
    <time_frame>72 hours after the end of procedure</time_frame>
    <description>Area under the curve of CK MB</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in cerebral oximetry</measure>
    <time_frame>through procedure completion, an average of 3 hours</time_frame>
    <description>changes in cerebral oximetry during the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delirum</measure>
    <time_frame>through admission completion, an average of 5 days</time_frame>
    <description>Newly onset delirium</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AKI or RRT</measure>
    <time_frame>through admission completion, an average of 5 days</time_frame>
    <description>Newly onset acute kidney injury or renal replacement therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>stroke, myocardial infarction or mortality</measure>
    <time_frame>through admission completion, an average of 5 days</time_frame>
    <description>Newly onset stroke, myocardial infarction or mortality</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Troponin</condition>
  <arm_group>
    <arm_group_label>Normoxemia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized to the normoxemia group receives inspired oxygen fraction of 0.3 from initiation of induction of anesthesia to the end of the procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hyperoxemia</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomized to the hyperoxemia group receives inspired oxygen fraction of 0.8 from initiation of induction of anesthesia to the end of the procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>normal inspired oxygen fraction</intervention_name>
    <description>receives inspired oxygen fraction of 0.3</description>
    <arm_group_label>Normoxemia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>high inspired oxygen fraction</intervention_name>
    <description>receives inspired oxygen fraction of 0.8</description>
    <arm_group_label>Hyperoxemia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Scheduled for transcatheter aortic valve replacement due to aortic stenosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Transapical approach&#xD;
&#xD;
          -  Pre-procedural PaO2 &lt; 65 mmHg or oxygen support therapy&#xD;
&#xD;
          -  Pre-procedural severe kidney injury (end-stage renal disease)&#xD;
&#xD;
          -  Pre-procedural chronic pulmonary disease, symptomatic asthma&#xD;
&#xD;
          -  Pre-procedural Tb-destroyed lung&#xD;
&#xD;
          -  Lung cancer&#xD;
&#xD;
          -  History of acute coronary syndrome within 6 months&#xD;
&#xD;
          -  Pre-procedural elevated Troponin I or CKMB&#xD;
&#xD;
          -  History of stroke or transient ischemic attack within 6 months&#xD;
&#xD;
          -  Refuse to participate&#xD;
&#xD;
          -  Pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yunseok Jeon, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>July 18, 2022</last_update_submitted>
  <last_update_submitted_qc>July 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Yunseok Jeon</investigator_full_name>
    <investigator_title>Prinicipal investigator</investigator_title>
  </responsible_party>
  <keyword>hyperoxemia</keyword>
  <keyword>myocardial injury</keyword>
  <keyword>transcatheter aortic valve replacement</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03291210
org study id: TAVI-O2
nct id: NCT03291210
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Hyperoxemia can produce various complications including oxidative stress and myocardial
      injury. We hypothesized that the normoxic group would have lower myocardial injury compared
      to hyperoxic group after transcatheter aortic valve replacement.
Hyperoxemia can produce various complications, such as excessive oxidative stress,
      hyperoxia-induced vasoconstriction, increased perfusion heterogeneity, and resultant
      myocardial injury. Previous studies have been observed higher mortality in patient group
      maintained with supranormal oxygenation after resuscitation from cardiac arrest. However, the
      effect of hyperoxia vs. normoxia on myocardial injury during transcatheter aortic valve
      replacement (TAVR) has not been well investigated. We hypothesized that the normoxic group
      would have lower myocardial injury compared to hyperoxic group after TAVR.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Troponin I
time frame: 72 hours after the end of procedure
description: Area under the curve of troponin I
measure: CK MB
time frame: 72 hours after the end of procedure
description: Area under the curve of CK MB
measure: Changes in cerebral oximetry
time frame: through procedure completion, an average of 3 hours
description: changes in cerebral oximetry during the procedure
measure: Delirum
time frame: through admission completion, an average of 5 days
description: Newly onset delirium
measure: AKI or RRT
time frame: through admission completion, an average of 5 days
description: Newly onset acute kidney injury or renal replacement therapy
measure: stroke, myocardial infarction or mortality
time frame: through admission completion, an average of 5 days
description: Newly onset stroke, myocardial infarction or mortality
arm group label: Normoxemia
arm group type: Experimental
description: Patients randomized to the normoxemia group receives inspired oxygen fraction of 0.3 from initiation of induction of anesthesia to the end of the procedure.
arm group label: Hyperoxemia
arm group type: Active Comparator
description: Patients randomized to the hyperoxemia group receives inspired oxygen fraction of 0.8 from initiation of induction of anesthesia to the end of the procedure.
intervention type: Other
intervention name: normal inspired oxygen fraction
description: receives inspired oxygen fraction of 0.3
arm group label: Normoxemia
intervention type: Other
intervention name: high inspired oxygen fraction
description: receives inspired oxygen fraction of 0.8
arm group label: Hyperoxemia
criteria: 
gender: All
minimum age: 20 Years
maximum age: 99 Years
healthy volunteers: No
last name: Yunseok Jeon, MD, PhD
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Yunseok Jeon
investigator title: Prinicipal investigator
sharing ipd: Undecided