<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/NCT02184702</url>
  </required_header>
  <id_info>
    <org_study_id>IIT-2014-192</org_study_id>
    <nct_id>NCT02184702</nct_id>
  </id_info>
  <brief_title>Effects of Shoulder Edema on Intubated Tube in Patients Undergoing Shoulder Arthroscopy</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inje University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fresenius Kabi Korea</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Inje University</source>
  <brief_summary>
    <textblock>
      Intubation is needed in general anesthesia and appropriate cuff pressure is important to&#xD;
      avoid trauma or postoperative sore throat and aspiration. Shoulder arthroscope uses some&#xD;
      amount of irrigation fluid and it can influence to cuff pressure. Therefore, we will measure&#xD;
      cuff pressure during shoulder arthroscope.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</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>Direct intracuff pressure measurement technique using manometer</measure>
    <time_frame>every one hour during operarion</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Arthroscopy</condition>
  <arm_group>
    <arm_group_label>shoulder arthroscopy</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patints who undergoing shoulder arthroscopy American Society of Anesthesiologists (ASA) 1,2&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) 1,2 Age 20-65&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  emergency operation anticipated difficult intubation chronic obstructive lung disease&#xD;
             recent upper respiratory infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sira Bang, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Inje University Seoul Paik Hospital, Seoul, Korea</affiliation>
  </overall_official>
  <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>August 2016</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>August 29, 2016</last_update_submitted>
  <last_update_submitted_qc>August 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 31, 2016</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>
  <!-- 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/NCT02184702
org study id: IIT-2014-192
nct id: NCT02184702
lead sponsor: 
collaborator: 
Intubation is needed in general anesthesia and appropriate cuff pressure is important to
      avoid trauma or postoperative sore throat and aspiration. Shoulder arthroscope uses some
      amount of irrigation fluid and it can influence to cuff pressure. Therefore, we will measure
      cuff pressure during shoulder arthroscope.
observational model: Case-Only
time perspective: Prospective
measure: Direct intracuff pressure measurement technique using manometer
time frame: every one hour during operarion
arm group label: shoulder arthroscopy
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Sira Bang, MD, PhD
role: Principal Investigator
affiliation: Inje University Seoul Paik Hospital, Seoul, Korea
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Inje University
investigator full name: Sira Bang
investigator title: Assistant professor