<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/NCT01700088</url>
  </required_header>
  <id_info>
    <org_study_id>541/2555(EC2)</org_study_id>
    <nct_id>NCT01700088</nct_id>
  </id_info>
  <brief_title>The Effect of Nasal Cannulae During the First 2 Hours Postoperative in Patient Undergoing Thoracotomy</brief_title>
  <official_title>The Effect of Nasal Cannulae During the First 2 Hours Postoperative in Patient</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mahidol University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      At our institute,during the first 2 hour postoperative, we used to give supplement oxygen via&#xD;
      face mask in patient having lung resection surgery. After then if the patient is fine, we'll&#xD;
      replace the face mask with nasal cannular untie the next morning. We hypothesized that oxygen&#xD;
      mask can be replace by nasal cannular without any hypoxia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Oxygen saturation</measure>
    <time_frame>30 minutes</time_frame>
    <description>We continuously monitor oxygen saturation and record every 5 minutes for 30 minutes postoperative.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of hypoxemia</measure>
    <time_frame>3 days postoperative</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">35</enrollment>
  <condition>Hypoxia</condition>
  <condition>Post Pulmonary Resection</condition>
  <arm_group>
    <arm_group_label>Oxygen cannular</arm_group_label>
    <description>After lung resection surgery,every patient will received supplementary oxygen 5 L/minutes via oxygen cannular for 120 minutes</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patient undergoing lung resection surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt;/= 18 years old&#xD;
&#xD;
          -  Patient undergoing lobectomy or pneumonectomy or wedge resection&#xD;
&#xD;
          -  ASA 1-3&#xD;
&#xD;
          -  Preoperative oxygen saturation &lt; 95 %&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cannot communication&#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>Sirilak Suksompong, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mahidol University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Medicine, Siriraj Hospital, Mahidol University</name>
      <address>
        <city>Bangkok</city>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>December 10, 2015</last_update_submitted>
  <last_update_submitted_qc>December 10, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 11, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mahidol University</investigator_affiliation>
    <investigator_full_name>Sirilak Suksompong</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>hypoxemia</keyword>
  <keyword>Post Pulmonary Resection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypoxia</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/NCT01700088
org study id: 541/2555(EC2)
nct id: NCT01700088
lead sponsor: 
has dmc: No
At our institute,during the first 2 hour postoperative, we used to give supplement oxygen via
      face mask in patient having lung resection surgery. After then if the patient is fine, we'll
      replace the face mask with nasal cannular untie the next morning. We hypothesized that oxygen
      mask can be replace by nasal cannular without any hypoxia.
observational model: Case-Only
time perspective: Prospective
measure: Oxygen saturation
time frame: 30 minutes
description: We continuously monitor oxygen saturation and record every 5 minutes for 30 minutes postoperative.
measure: Incidence of hypoxemia
time frame: 3 days postoperative
arm group label: Oxygen cannular
description: After lung resection surgery,every patient will received supplementary oxygen 5 L/minutes via oxygen cannular for 120 minutes
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sirilak Suksompong, MD
role: Principal Investigator
affiliation: Mahidol University
facility: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Mahidol University
investigator full name: Sirilak Suksompong
investigator title: Associate Professor
mesh term: Hypoxia