<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/NCT03785314</url>
  </required_header>
  <id_info>
    <org_study_id>2018-11-039</org_study_id>
    <nct_id>NCT03785314</nct_id>
  </id_info>
  <brief_title>Optic Nerve Sheath Diameter Difference</brief_title>
  <official_title>Effect of Different Posture on Optic Nerve Sheath Diameter During Thoracic Epidural Catheterization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Keimyung University Dongsan Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Keimyung University Dongsan Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Intracranial pressure is measured indirectly using optic nerve sheath diameter with&#xD;
      ultrasound. It is reported that epidural pressure varies according to different posture (&#xD;
      lateral decubitus vs. sitting position).&#xD;
&#xD;
      This study is designed to measure the optic nerve sheath diameter in lateral decubitus and&#xD;
      sitting position, respectively.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      According to previous study, injection of different volume of local anesthetics (1.0 ml/kg&#xD;
      vs. 1.5 ml/kg) during caudal anesthesia, high volume of local anesthetics resulted in&#xD;
      significant increase of intracranial pressure (ICP). Increase of ICP can reduce regional&#xD;
      cerebral flow and oxygen saturation causing the safety of patients. In addition, increase of&#xD;
      ICP can result in headache, syncope, and transient loss of visual acuity. Although it is very&#xD;
      invasive method, ICP can be measured directly at the brain parenchyme. Among methods to&#xD;
      measure the ICP indirectly, measurement of optic nerve sheath diameter using ultrasound is&#xD;
      known to reflect the degree of ICP. It is reported that optic nerve sheath diameter increases&#xD;
      when higher volume of medication is injected during epidural anesthesia. Previous reports&#xD;
      showed that epidural pressure varies according to different posture. When epidural pressure&#xD;
      was measured in patients of spinal stenosis, lumbar flexion showed lower epidural pressure&#xD;
      than epidural pressure of lumbar extension. In addition, when epidural pressure was measured&#xD;
      in the sitting position, it showed lower pressure than pressure of lateral decubitus.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2019</start_date>
  <completion_date type="Actual">December 30, 2019</completion_date>
  <primary_completion_date type="Actual">October 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>optic nerve sheath diameter change among 4 time period</measure>
    <time_frame>Baseline, 10 minutes, 20 minutes, 40 minutes after the completion of the intervention</time_frame>
    <description>optic nerve sheath diameter change among 4 time period using ultrasound</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Optic Neve Sheath Diameter</condition>
  <arm_group>
    <arm_group_label>injection under sitting position</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>saline injection under sitting position during thoracic epidural catheterization</description>
  </arm_group>
  <arm_group>
    <arm_group_label>injection under lateral decubitus position</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>saline injection under lateral decubitus position during thoracic epidural catheterization</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>thoracic epidural catheterization</intervention_name>
    <description>thoracic epidural catheterization with different posture</description>
    <arm_group_label>injection under lateral decubitus position</arm_group_label>
    <arm_group_label>injection under sitting position</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  lung cancer&#xD;
&#xD;
          -  liver cancer&#xD;
&#xD;
          -  stomach cancer&#xD;
&#xD;
          -  pancreas cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  coagulopathy&#xD;
&#xD;
          -  infection&#xD;
&#xD;
          -  previous spine fusion at thoracic level&#xD;
&#xD;
          -  previous brain surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ji Hee Hong, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Keimyung University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hong ji HEE</name>
      <address>
        <city>Daegu</city>
        <zip>42601</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>February 20, 2020</last_update_submitted>
  <last_update_submitted_qc>February 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Keimyung University Dongsan Medical Center</investigator_affiliation>
    <investigator_full_name>Ji Hee Hong</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Optic Nerve Sheath Diameter Different Position</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT03785314
org study id: 2018-11-039
nct id: NCT03785314
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Intracranial pressure is measured indirectly using optic nerve sheath diameter with
      ultrasound. It is reported that epidural pressure varies according to different posture (
      lateral decubitus vs. sitting position).

      This study is designed to measure the optic nerve sheath diameter in lateral decubitus and
      sitting position, respectively.
According to previous study, injection of different volume of local anesthetics (1.0 ml/kg
      vs. 1.5 ml/kg) during caudal anesthesia, high volume of local anesthetics resulted in
      significant increase of intracranial pressure (ICP). Increase of ICP can reduce regional
      cerebral flow and oxygen saturation causing the safety of patients. In addition, increase of
      ICP can result in headache, syncope, and transient loss of visual acuity. Although it is very
      invasive method, ICP can be measured directly at the brain parenchyme. Among methods to
      measure the ICP indirectly, measurement of optic nerve sheath diameter using ultrasound is
      known to reflect the degree of ICP. It is reported that optic nerve sheath diameter increases
      when higher volume of medication is injected during epidural anesthesia. Previous reports
      showed that epidural pressure varies according to different posture. When epidural pressure
      was measured in patients of spinal stenosis, lumbar flexion showed lower epidural pressure
      than epidural pressure of lumbar extension. In addition, when epidural pressure was measured
      in the sitting position, it showed lower pressure than pressure of lateral decubitus.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: optic nerve sheath diameter change among 4 time period
time frame: Baseline, 10 minutes, 20 minutes, 40 minutes after the completion of the intervention
description: optic nerve sheath diameter change among 4 time period using ultrasound
arm group label: injection under sitting position
arm group type: Active Comparator
description: saline injection under sitting position during thoracic epidural catheterization
arm group label: injection under lateral decubitus position
arm group type: Active Comparator
description: saline injection under lateral decubitus position during thoracic epidural catheterization
intervention type: Other
intervention name: thoracic epidural catheterization
description: thoracic epidural catheterization with different posture
arm group label: injection under lateral decubitus position
arm group label: injection under sitting position
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ji Hee Hong, PhD
role: Principal Investigator
affiliation: Keimyung University
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Keimyung University Dongsan Medical Center
investigator full name: Ji Hee Hong
investigator title: Professor
sharing ipd: No