<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/NCT01725464</url>
  </required_header>
  <id_info>
    <org_study_id>541/2555(EC)</org_study_id>
    <nct_id>NCT01725464</nct_id>
  </id_info>
  <brief_title>The Effect of Nasal Cannula During the First 2 Hours Postoperative in Patient Undergoing Thoracotomy</brief_title>
  <official_title>The Effect of Nasal Cannula During the First 2 Hours Postoperative in Patient Undergoing Thoracotomy</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>
      During early postoperative after lung resection surgery, patients without oxygen&#xD;
      supplementation may experience hypoxemia. Oxygen supplementation can be given via oxygen mask&#xD;
      or cannular. In this study the investigators want to the sudy the effect of oxygen&#xD;
      supplementation via oxygen cannular during the first 120 minutes after surgery&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean oxygen saturation at 30 minutes postoperative</measure>
    <time_frame>30 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>incidence of oxygen saturation &lt; 95% between 120 minutes until 3 days postoperative</measure>
    <time_frame>3 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Lung Surgery</condition>
  <condition>Hypoxia</condition>
  <condition>Postoperative</condition>
  <arm_group>
    <arm_group_label>oxygen cannular</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient receives oxygen supplementation 5 LPM via oxygen cannular for 120 minutes after the operative</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>oxygen cannular</intervention_name>
    <description>Patient receives oxygen supplementation 5 LPM via oxygen cannular for 120 minutes after the operative</description>
    <arm_group_label>oxygen cannular</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age =/&gt; 18 years&#xD;
&#xD;
          -  lobectomy or pneumonectomy or wedge resection&#xD;
&#xD;
          -  ASA 1-3&#xD;
&#xD;
          -  preoperative oxygen saturation &lt; 95 %&#xD;
&#xD;
          -  receiving epidural analgesia&#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>Sirilak Suksompong</name>
      <address>
        <city>Bangkok</city>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>August 2013</verification_date>
  <study_first_submitted>November 8, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>August 16, 2013</last_update_submitted>
  <last_update_submitted_qc>August 16, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 19, 2013</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 Profesor</investigator_title>
  </responsible_party>
  <keyword>thoracotomy</keyword>
  <keyword>oxygen saturation</keyword>
  <keyword>postoperative</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/NCT01725464
org study id: 541/2555(EC)
nct id: NCT01725464
lead sponsor: 
has dmc: No
During early postoperative after lung resection surgery, patients without oxygen
      supplementation may experience hypoxemia. Oxygen supplementation can be given via oxygen mask
      or cannular. In this study the investigators want to the sudy the effect of oxygen
      supplementation via oxygen cannular during the first 120 minutes after surgery
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean oxygen saturation at 30 minutes postoperative
time frame: 30 minutes
measure: incidence of oxygen saturation < 95% between 120 minutes until 3 days postoperative
time frame: 3 days
arm group label: oxygen cannular
arm group type: Experimental
description: Patient receives oxygen supplementation 5 LPM via oxygen cannular for 120 minutes after the operative
intervention type: Device
intervention name: oxygen cannular
description: Patient receives oxygen supplementation 5 LPM via oxygen cannular for 120 minutes after the operative
arm group label: oxygen cannular
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 Profesor
mesh term: Hypoxia