<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/NCT03782077</url>
  </required_header>
  <id_info>
    <org_study_id>2018-1172</org_study_id>
    <nct_id>NCT03782077</nct_id>
  </id_info>
  <brief_title>Change of Optic Nerve Sheath Diameter After Deflation of Pneumatic Tourniquet</brief_title>
  <official_title>Effect of Deflation of Pneumatic Tourniquet on the Change of Optic Nerve Sheath Diameter in Patients Undergoing Knee Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asan Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asan Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the change of the optic nerve sheath diameter after&#xD;
      deflation of pneumatic tourniquet.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Deflation of pneumatic tourniquet could induces many changes in various organ systems. It has&#xD;
      been shown to affect intracranial pressure. Thus, the investigators evaluate the change of&#xD;
      optic nerve sheath diameter using ultrasound after deflation of pneumatic tourniquet in&#xD;
      patients undergoing knee surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 15, 2018</start_date>
  <completion_date type="Actual">December 13, 2018</completion_date>
  <primary_completion_date type="Actual">December 13, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>change of optic nerve sheath diameter</measure>
    <time_frame>5 minutes before deflation and at 5-minute intervals for 10 minutes after deflation</time_frame>
    <description>difference in optic nerve sheath diameter measured using ultrasound before and after deflation of pneumatic tourniquet</description>
  </primary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Intracranial Pressure Increase</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Deflation of pneumatic tourniquet</intervention_name>
    <description>Deflation of pneumatic tourniquet</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing knee surgery using pneumatic tourniquet&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA physical status 1-4&#xD;
&#xD;
          -  patients undergoing knee surgery using pneumatic tourniquet&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who refuse to participate in this study&#xD;
&#xD;
          -  patients with history of cerebrovascular disease&#xD;
&#xD;
          -  patients who are judged ineligible by the medical staff to participate in the study&#xD;
             for other reasons&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Won Uk Koh, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asan Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>December 19, 2018</last_update_submitted>
  <last_update_submitted_qc>December 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Asan Medical Center</investigator_affiliation>
    <investigator_full_name>Hajung Kim</investigator_full_name>
    <investigator_title>Clinical instructor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intracranial Hypertension</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/NCT03782077
org study id: 2018-1172
nct id: NCT03782077
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the change of the optic nerve sheath diameter after
      deflation of pneumatic tourniquet.
Deflation of pneumatic tourniquet could induces many changes in various organ systems. It has
      been shown to affect intracranial pressure. Thus, the investigators evaluate the change of
      optic nerve sheath diameter using ultrasound after deflation of pneumatic tourniquet in
      patients undergoing knee surgery.
observational model: Cohort
time perspective: Prospective
measure: change of optic nerve sheath diameter
time frame: 5 minutes before deflation and at 5-minute intervals for 10 minutes after deflation
description: difference in optic nerve sheath diameter measured using ultrasound before and after deflation of pneumatic tourniquet
intervention type: Procedure
intervention name: Deflation of pneumatic tourniquet
description: Deflation of pneumatic tourniquet
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 79 Years
last name: Won Uk Koh, M.D., Ph.D.
role: Principal Investigator
affiliation: Asan Medical Center
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Asan Medical Center
investigator full name: Hajung Kim
investigator title: Clinical instructor
mesh term: Intracranial Hypertension
sharing ipd: Undecided