<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/NCT02184728</url>
  </required_header>
  <id_info>
    <org_study_id>IIT-2014-215</org_study_id>
    <nct_id>NCT02184728</nct_id>
  </id_info>
  <brief_title>Comparison of End-tidal Carbon Dioxide (ETCO2) Measured by Transportable Capnometer (EMMATM) and the Arterial pCO2 in General Anesthesia</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inje University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Inje University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      An end-tidal CO 2 monitor (capnometer) is used most often as a noninvasive substitute for&#xD;
      PaCO2 in anesthesia, anesthetic recovery and intensive care. There is now also wide-spread&#xD;
      use of capnometry on-site at emergency and trauma fields. So, portable device can be used&#xD;
      usefully.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <phase>N/A</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>End-tidal CO2</measure>
    <time_frame>During operation (2-4 times)</time_frame>
    <description>End-tidal CO2(portable capnometer: EMMATM, Side stream capnometry module:Datex-Ohmeda S5 Anesthesia Monitor )levels were recorded at the time of arterial blood gas sampling.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>End Tidal Carbon Dioxide of Patients Undergoing General Anesthesia</condition>
  <arm_group>
    <arm_group_label>EMMA(TM)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>A small capnograph for measuring ET-CO2 - the EMMA capnometer&#xD;
1</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>End-tidal CO2(portable capnometer)</intervention_name>
    <description>End-tidal CO2(portable capnometer: EMMATM, Side stream capnometry module:Datex-Ohmeda S5 Anesthesia Monitor )levels were recorded at the time of arterial blood gas sampling.</description>
    <arm_group_label>EMMA(TM)</arm_group_label>
    <other_name>EMMA(TM )</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who anticipated arterial gas analyze intraoperatively&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who didn't get arterial line&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Inje University Seoul Paik Hospital, Seoul, Korea</name>
      <address>
        <city>Seoul</city>
        <state>Jung-Gu,</state>
        <zip>100-032</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>March 23, 2015</last_update_submitted>
  <last_update_submitted_qc>March 23, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 25, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Inje University</investigator_affiliation>
    <investigator_full_name>Sira Bang</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>end-tidal CO2</keyword>
  <keyword>capnometer</keyword>
  <!-- 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/NCT02184728
org study id: IIT-2014-215
nct id: NCT02184728
lead sponsor: 
has dmc: No
An end-tidal CO 2 monitor (capnometer) is used most often as a noninvasive substitute for
      PaCO2 in anesthesia, anesthetic recovery and intensive care. There is now also wide-spread
      use of capnometry on-site at emergency and trauma fields. So, portable device can be used
      usefully.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: End-tidal CO2
time frame: During operation (2-4 times)
description: End-tidal CO2(portable capnometer: EMMATM, Side stream capnometry module:Datex-Ohmeda S5 Anesthesia Monitor )levels were recorded at the time of arterial blood gas sampling.
arm group label: EMMA(TM)
arm group type: No Intervention
description: A small capnograph for measuring ET-CO2 - the EMMA capnometer
1
intervention type: Device
intervention name: End-tidal CO2(portable capnometer)
description: End-tidal CO2(portable capnometer: EMMATM, Side stream capnometry module:Datex-Ohmeda S5 Anesthesia Monitor )levels were recorded at the time of arterial blood gas sampling.
arm group label: EMMA(TM)
other name: EMMA(TM )
criteria: 
gender: All
minimum age: 20 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Inje University
investigator full name: Sira Bang
investigator title: Assistant Professor