<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/NCT03006224</url>
  </required_header>
  <id_info>
    <org_study_id>Asozkan-5</org_study_id>
    <nct_id>NCT03006224</nct_id>
  </id_info>
  <brief_title>The Effects of Secondary Smoking During One Lung Ventilation</brief_title>
  <official_title>The Effects of Secondary Smoking to Intraoperative Arterial Oxygen Tension During One Lung Ventilation in Lobectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inonu University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Inonu University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Smoking and perhaps secondary smoking is associated with many perioperative and postoperative&#xD;
      complications, especially respiratory events. Hypoxemia and airway damage can be associated&#xD;
      with secondary smoking. The aim of study is to predict the incidence of hypoxemia and airway&#xD;
      damage during one lung ventilation for lobectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sixty patients undergoing lobectomy using one lung ventilation by double lumen tube will be&#xD;
      included in this study. These patients will be divided into 2 groups. Groups S which will be&#xD;
      included non smoking and secondary smoking and group SS which will be included secondary&#xD;
      smoking ( smoking near him more than 10 cigarettes per day fore more than 5 years). Intra and&#xD;
      postoperative arterial oxygen tension, arterial carbon dioxide tension and intraoperative&#xD;
      peak airway pressure will be compared between the two groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">April 4, 2017</completion_date>
  <primary_completion_date type="Actual">February 2017</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>Other</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>arterial oxygen tension</measure>
    <time_frame>From beginning of Anesthesia to 1st day of surgery</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>arterial carbon dioxide tension</measure>
    <time_frame>From beginning of Anesthesia to 1st day of surgery</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>intraoperative peak airway pressure</measure>
    <time_frame>during intraoperative ventilation</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Smoking</condition>
  <condition>Oxygen Deficiencies</condition>
  <arm_group>
    <arm_group_label>Group S (non smoking and secondary smoking)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>I want to see the effects of seconder smoking to intraoperative arterial oxygen tension during one lung ventilation for lobectomy surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group SS (secondary smoking)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>I want to see the effects of seconder smoking to intraoperative arterial oxygen tension during one lung ventilation for lobectomy surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>One Lung Ventilation</intervention_name>
    <arm_group_label>Group S (non smoking and secondary smoking)</arm_group_label>
    <arm_group_label>Group SS (secondary smoking)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sixty patients undergoing lobectomy using one lung ventilation by double lumen tube,&#xD;
             ASA physical status 2 and 3.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recent chest infection, morbid obesity, renal, hepatic and ischemic hearts disease,&#xD;
             asthma.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>April 4, 2017</last_update_submitted>
  <last_update_submitted_qc>April 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Inonu University</investigator_affiliation>
    <investigator_full_name>Ahmet Selim Ozkan</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>secondary smoking</keyword>
  <keyword>one lung ventilation</keyword>
  <keyword>arterial oxygen tension</keyword>
  <keyword>lobectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypoxia</mesh_term>
  </condition_browse>
  <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/NCT03006224
org study id: Asozkan-5
nct id: NCT03006224
lead sponsor: 
has dmc: No
Smoking and perhaps secondary smoking is associated with many perioperative and postoperative
      complications, especially respiratory events. Hypoxemia and airway damage can be associated
      with secondary smoking. The aim of study is to predict the incidence of hypoxemia and airway
      damage during one lung ventilation for lobectomy.
Sixty patients undergoing lobectomy using one lung ventilation by double lumen tube will be
      included in this study. These patients will be divided into 2 groups. Groups S which will be
      included non smoking and secondary smoking and group SS which will be included secondary
      smoking ( smoking near him more than 10 cigarettes per day fore more than 5 years). Intra and
      postoperative arterial oxygen tension, arterial carbon dioxide tension and intraoperative
      peak airway pressure will be compared between the two groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Investigator)
measure: arterial oxygen tension
time frame: From beginning of Anesthesia to 1st day of surgery
measure: arterial carbon dioxide tension
time frame: From beginning of Anesthesia to 1st day of surgery
measure: intraoperative peak airway pressure
time frame: during intraoperative ventilation
arm group label: Group S (non smoking and secondary smoking)
arm group type: Active Comparator
description: I want to see the effects of seconder smoking to intraoperative arterial oxygen tension during one lung ventilation for lobectomy surgery.
arm group label: Group SS (secondary smoking)
arm group type: Active Comparator
description: I want to see the effects of seconder smoking to intraoperative arterial oxygen tension during one lung ventilation for lobectomy surgery.
intervention type: Other
intervention name: One Lung Ventilation
arm group label: Group S (non smoking and secondary smoking)
arm group label: Group SS (secondary smoking)
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Inonu University
investigator full name: Ahmet Selim Ozkan
investigator title: M.D.
mesh term: Hypoxia
sharing ipd: Undecided