<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/NCT03806504</url>
  </required_header>
  <id_info>
    <org_study_id>2018/6/62</org_study_id>
    <nct_id>NCT03806504</nct_id>
  </id_info>
  <brief_title>High PEEP Application Following Pulmonary Thromboendarterectomy; Does it Have Any Impact on Outcome?</brief_title>
  <official_title>Prospective Randomized Trial of Impact of High PEEP Application Following Pulmonary Endarterectomy on Outcome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kartal Kosuyolu Yuksek Ihtisas Education and Research 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>
      Investigation of the effect of intraoperative lung protection high PEEP maneuver on ischemic&#xD;
      reperfusion injury in patients undergoing pulmonary endarterectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare disease characterized by&#xD;
      progression of thromboembolism obstructing pulmonary arteries as an organized tissue.&#xD;
      Pulmonary thromboendarterectomy (PTE) is a treatment option for chronic thromboembolic&#xD;
      pulmonary disease. However, PTE is associated with specific postoperative complications, such&#xD;
      as pulmonary edema and right ventricular failure due to reperfusion injury, with a&#xD;
      significant mortality rate of 7% to 24%. Some strategies have been proposed to reduce lung&#xD;
      injury after PTE, such as rectification maneuvers and high PEEP. The aim of this study was to&#xD;
      investigate the effect of intraoperative lung protection high PEEP maneuver in patients&#xD;
      undergoing pulmonary endarterectomy for ischemic reperfusion injury.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</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>
    <intervention_model_description>prospective, randomized</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>free oxygen radicals levels</measure>
    <time_frame>48 hours</time_frame>
    <description>Superoxide dismutase (SOD) activity will be measured by modification of the method of Sun et al. and Protein carbonyl groups will be determined by volume modification according to Reznick and Packer method.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>postoperatif outcome - Duration of stay in the intensive care unit and hospital stay</measure>
    <time_frame>10 day</time_frame>
    <description>Duration of stay in the intensive care unit and hospital stay after pte operation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Reperfusion Injury After Pulmonary Thromboendarterektomy</condition>
  <arm_group>
    <arm_group_label>high PEEP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>35 cm/H2O PEEP, 2-3 ml/kg tidal volume,45 seconds, after cardiopulmonary bypass</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>6 cm/H2O PEEP, 6-8 ml/kg tidal volume, continues, after cardiopulmonary bypass</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PEEP</intervention_name>
    <description>performing 35 cm/H2O PEEP and 2-3 ml/kg tidal volume</description>
    <arm_group_label>high PEEP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>control group</intervention_name>
    <description>performing 6 cm/H2O PEEP and 6-8 ml/kg tidal volume</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing elective PTE operation due to CTEPH,&#xD;
&#xD;
          -  20-70 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with chronic inflammatory disease,&#xD;
&#xD;
          -  liver and renal failure,&#xD;
&#xD;
          -  heart failure (&lt;EF: 40%),&#xD;
&#xD;
          -  intraoperative bronchial hemorrhage,&#xD;
&#xD;
          -  patients undergoing postoperative revision.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Mustafa EMRE Gurcu</name>
      <address>
        <city>Istanbul</city>
        <zip>34865</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>May 6, 2021</last_update_submitted>
  <last_update_submitted_qc>May 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>mustafa emre gürcü</investigator_full_name>
    <investigator_title>anesthesia and reanimation specialist</investigator_title>
  </responsible_party>
  <keyword>Chronic thromboembolic pulmonary hypertension</keyword>
  <keyword>PEEP</keyword>
  <keyword>reperfusion injury</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Reperfusion Injury</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/NCT03806504
org study id: 2018/6/62
nct id: NCT03806504
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Investigation of the effect of intraoperative lung protection high PEEP maneuver on ischemic
      reperfusion injury in patients undergoing pulmonary endarterectomy.
Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare disease characterized by
      progression of thromboembolism obstructing pulmonary arteries as an organized tissue.
      Pulmonary thromboendarterectomy (PTE) is a treatment option for chronic thromboembolic
      pulmonary disease. However, PTE is associated with specific postoperative complications, such
      as pulmonary edema and right ventricular failure due to reperfusion injury, with a
      significant mortality rate of 7% to 24%. Some strategies have been proposed to reduce lung
      injury after PTE, such as rectification maneuvers and high PEEP. The aim of this study was to
      investigate the effect of intraoperative lung protection high PEEP maneuver in patients
      undergoing pulmonary endarterectomy for ischemic reperfusion injury.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: prospective, randomized
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: free oxygen radicals levels
time frame: 48 hours
description: Superoxide dismutase (SOD) activity will be measured by modification of the method of Sun et al. and Protein carbonyl groups will be determined by volume modification according to Reznick and Packer method.
measure: postoperatif outcome - Duration of stay in the intensive care unit and hospital stay
time frame: 10 day
description: Duration of stay in the intensive care unit and hospital stay after pte operation
arm group label: high PEEP
arm group type: Active Comparator
description: 35 cm/H2O PEEP, 2-3 ml/kg tidal volume,45 seconds, after cardiopulmonary bypass
arm group label: control group
arm group type: Active Comparator
description: 6 cm/H2O PEEP, 6-8 ml/kg tidal volume, continues, after cardiopulmonary bypass
intervention type: Other
intervention name: PEEP
description: performing 35 cm/H2O PEEP and 2-3 ml/kg tidal volume
arm group label: high PEEP
intervention type: Other
intervention name: control group
description: performing 6 cm/H2O PEEP and 6-8 ml/kg tidal volume
arm group label: control group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
investigator full name: mustafa emre gürcü
investigator title: anesthesia and reanimation specialist
mesh term: Reperfusion Injury