<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/NCT04412109</url>
  </required_header>
  <id_info>
    <org_study_id>2020-01-081</org_study_id>
    <nct_id>NCT04412109</nct_id>
  </id_info>
  <brief_title>Optic Nerve Sheath Diameter Difference Between Different Injection Volume</brief_title>
  <official_title>Effect of Normal Saline Injection Volume on Epidural Pressure and Optic Nerve Sheath Diameter</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>
      Valid method of indirect measurement of intracranial pressure is using optic nerve sheath&#xD;
      diameter. Different volume of injection is known to affect the degree of increase of&#xD;
      intracranial pressure.&#xD;
&#xD;
      This study is desinged to measure the changes of optic nerve sheath diameter and cerebral&#xD;
      oxygenation when different volume of normal saline was injected.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Previous study showed that different volume of injections (1.0 ml/kg vs. 1.5 ml/kg) during&#xD;
      caudal anesthesia showed siginifiant increase of optic nerve sheath diameter in group of high&#xD;
      volumes. Increase of ICP can result in harmful effect including reduced cerebral flow and&#xD;
      oxygen saturation. Also, increase of ICP can cause headache, syncope and transient loss of&#xD;
      visual acuity. The proven and valid method of measuring ICP indirectly is using optic nerve&#xD;
      sheath diameter.&#xD;
&#xD;
      This study was designed to examine the changes of optic nerve sheath diameter and cerebral&#xD;
      oxygenation when different volume of normal saline was injected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 25, 2020</start_date>
  <completion_date type="Actual">November 16, 2020</completion_date>
  <primary_completion_date type="Actual">November 16, 2020</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 change during 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 change during 4 time period using ultrasound</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>cerebral oxygenation change during 4 time period</measure>
    <time_frame>Baseline, 10 minutes, 20 minutes, 40 minutes after the completion of the intervention</time_frame>
    <description>cerebral oxygenation change during 4 time period using pressure monitoring kit</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Optic Nerve Sheath Diameter</condition>
  <arm_group>
    <arm_group_label>injection of low volume of saline</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>low volume (5 cc) saline injection during thoracic epidural catheterization</description>
  </arm_group>
  <arm_group>
    <arm_group_label>injection of intermediate volume of saline</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>intermediate volume (10 cc) saline injection during thoracic epidural catheterization</description>
  </arm_group>
  <arm_group>
    <arm_group_label>injection of high volume of saline</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>high volume (20 cc) saline injection during thoracic epidural catheterization</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>thoracic epidural catheterization</intervention_name>
    <description>thoracic epidural catheterization for postoperative pain control</description>
    <arm_group_label>injection of high volume of saline</arm_group_label>
    <arm_group_label>injection of intermediate volume of saline</arm_group_label>
    <arm_group_label>injection of low volume of saline</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;
          -  gallbladder cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  coagulopathy&#xD;
&#xD;
          -  infection&#xD;
&#xD;
          -  previous spine fusion at thoracic level&#xD;
&#xD;
          -  previous brain lesion causing increased intracranial pressure&#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>November 2020</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>November 16, 2020</last_update_submitted>
  <last_update_submitted_qc>November 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 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 volume</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/NCT04412109
org study id: 2020-01-081
nct id: NCT04412109
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Valid method of indirect measurement of intracranial pressure is using optic nerve sheath
      diameter. Different volume of injection is known to affect the degree of increase of
      intracranial pressure.

      This study is desinged to measure the changes of optic nerve sheath diameter and cerebral
      oxygenation when different volume of normal saline was injected.
Previous study showed that different volume of injections (1.0 ml/kg vs. 1.5 ml/kg) during
      caudal anesthesia showed siginifiant increase of optic nerve sheath diameter in group of high
      volumes. Increase of ICP can result in harmful effect including reduced cerebral flow and
      oxygen saturation. Also, increase of ICP can cause headache, syncope and transient loss of
      visual acuity. The proven and valid method of measuring ICP indirectly is using optic nerve
      sheath diameter.

      This study was designed to examine the changes of optic nerve sheath diameter and cerebral
      oxygenation when different volume of normal saline was injected.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: optic nerve sheath change during 4 time period
time frame: Baseline, 10 minutes, 20 minutes, 40 minutes after the completion of the intervention
description: optic nerve sheath change during 4 time period using ultrasound
measure: cerebral oxygenation change during 4 time period
time frame: Baseline, 10 minutes, 20 minutes, 40 minutes after the completion of the intervention
description: cerebral oxygenation change during 4 time period using pressure monitoring kit
arm group label: injection of low volume of saline
arm group type: Active Comparator
description: low volume (5 cc) saline injection during thoracic epidural catheterization
arm group label: injection of intermediate volume of saline
arm group type: Active Comparator
description: intermediate volume (10 cc) saline injection during thoracic epidural catheterization
arm group label: injection of high volume of saline
arm group type: Active Comparator
description: high volume (20 cc) saline injection during thoracic epidural catheterization
intervention type: Procedure
intervention name: thoracic epidural catheterization
description: thoracic epidural catheterization for postoperative pain control
arm group label: injection of high volume of saline
arm group label: injection of intermediate volume of saline
arm group label: injection of low volume of saline
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