xml: <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/NCT06013189</url>
    </required_header>
    <id_info>
      <org_study_id>ATADEK 2019-19/21</org_study_id>
      <nct_id>NCT06013189</nct_id>
    </id_info>
    <brief_title>Re-Adjustment of Sweep Gas Flow to the During the Rewarming Period of the Cardiopulmonary Bypass</brief_title>
    <official_title>Re-Adjustment of Sweep Gas Flow to the During the Rewarming Period of the Cardiopulmonary Bypass to Prevent Alkalosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Acıbadem Atunizade Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Acıbadem Atunizade Hospital</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 investigators designed this prospective observational study with the theory that&#xD;
        alkalosis caused by decreased CO2 solubility due to temperature increase during the rewarming&#xD;
        period of the Cardiopulmonary Bypass could be prevented by reducing the sweep gas flow during&#xD;
        the rewarming period.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 7, 2023</start_date>
    <completion_date type="Anticipated">November 2034</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>2 Months</target_duration>
    <primary_outcome>
      <measure>Arterial pH lever lower than 7.30</measure>
      <time_frame>during the cardiopulmonary bypass and postoperative 24th hour</time_frame>
      <description>maintaining physiological pH</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>rSO2 20% below initial value</measure>
      <time_frame>during the cardiopulmonary bypass</time_frame>
      <description>observing the rSO2 of brain during rewarming period</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Optimal Sweep Gas Flow</condition>
    <condition>Determination of Optimal Sweep Gas Flow for Different Phases of Cardiopulmonary Bypass</condition>
    <arm_group>
      <arm_group_label>Group 1</arm_group_label>
      <description>Sweep Gas Flow did not changed (1.35 L/m2/min)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2</arm_group_label>
      <description>Sweep Gas Flow decreased during rewarming (1.2 L/m2/min)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 3</arm_group_label>
      <description>Sweep Gas Flow decreased during rewarming (1 L/m2/min)</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Gas Flow Adjustment</intervention_name>
      <description>Decreased gas flow causes PaCO2 to elevate and prevents alkalosis</description>
      <arm_group_label>Group 2</arm_group_label>
      <arm_group_label>Group 3</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients over 18 years of age scheduled for elective CPB surgery&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients over 18 years of age&#xD;
  &#xD;
            -  Elective CPB surgery&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients undergoing minimally invasive surgery&#xD;
  &#xD;
            -  Patients undergoing robotic cardiac surgery,&#xD;
  &#xD;
            -  Patients undergoing deep hypothermia,&#xD;
  &#xD;
            -  Patients undergoing total circulatory arrest,&#xD;
  &#xD;
            -  Patients whose FiO2 requirement is high that cannot be applied to target gas flow&#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_contact>
      <last_name>Melis Tosun, MD</last_name>
      <phone>00905356694002</phone>
      <email>melistosun@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Acıbadem Altunizade Hastanesi İstanbul</name>
        <address>
          <city>Istanbul</city>
          <state>Altunizade</state>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Melis Tosun, MD</last_name>
        <phone>00905356694002</phone>
        <email>melistosun@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Acıbadem Atunizade Hospital</investigator_affiliation>
      <investigator_full_name>Melis Tosun</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>sweep gas flow</keyword>
    <keyword>rewarming</keyword>
    <keyword>cardiopulmonary bypass</keyword>
    <keyword>alkalosis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Alkalosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06013189
  org study id: ATADEK 2019-19/21
  nct id: NCT06013189
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The investigators designed this prospective observational study with the theory that
        alkalosis caused by decreased CO2 solubility due to temperature increase during the rewarming
        period of the Cardiopulmonary Bypass could be prevented by reducing the sweep gas flow during
        the rewarming period.
  observational model: Cohort
  time perspective: Prospective
  measure: Arterial pH lever lower than 7.30
  time frame: during the cardiopulmonary bypass and postoperative 24th hour
  description: maintaining physiological pH
  measure: rSO2 20% below initial value
  time frame: during the cardiopulmonary bypass
  description: observing the rSO2 of brain during rewarming period
  arm group label: Group 1
  description: Sweep Gas Flow did not changed (1.35 L/m2/min)
  arm group label: Group 2
  description: Sweep Gas Flow decreased during rewarming (1.2 L/m2/min)
  arm group label: Group 3
  description: Sweep Gas Flow decreased during rewarming (1 L/m2/min)
  intervention type: Other
  intervention name: Gas Flow Adjustment
  description: Decreased gas flow causes PaCO2 to elevate and prevents alkalosis
  arm group label: Group 2
  arm group label: Group 3
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Melis Tosun, MD
  phone: 00905356694002
  email: melistosun@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Acıbadem Atunizade Hospital
  investigator full name: Melis Tosun
  investigator title: Principal Investigator
  mesh term: Alkalosis
  sharing ipd: No