<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/NCT03795896</url>
  </required_header>
  <id_info>
    <org_study_id>Ms/15.05.88</org_study_id>
    <nct_id>NCT03795896</nct_id>
  </id_info>
  <brief_title>Ocular Ultrasonography as a Tool for Monitoring the Management of Traumatic Brain Injury</brief_title>
  <official_title>Ocular Ultrasonography in Assessing Severity and Management of Increased Intracranial Pressure in Traumatic Brain Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University Hospital</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>
      Raised intracranial pressure (ICP) is a common and life threatening condition especially in&#xD;
      patients with traumatic brain injury.There are many methods for monitoring the increased&#xD;
      (ICP) either invasive or non- invasive ,but the gold standard is invasive method. Optic nerve&#xD;
      sheath ultrasonography provides a very promising bedside tool for detection of increased ICP.&#xD;
      This study will monitor the dynamic changes of intracranial pressure by optic nerve sheath&#xD;
      diameter (ONSD) in response to mannitol osmotherapy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Traumatic brain injury is the main cause of increased intracranial pressure (ICP) in the&#xD;
      intensive care .&#xD;
&#xD;
      There are multiple methods for monitoring the raised ICP either invasive or non-invasive.The&#xD;
      gold standard is the invasive devices because it is more accurate and reliable .However ,it&#xD;
      requires a surgical intervention which has many hazards such as (infection&#xD;
      ,hemorrhage,malfunction ).&#xD;
&#xD;
      Optic nerve sheath ultrasonography is a promising bedside tool for detection of increased&#xD;
      ICP. The optic nerve is surrounded by cerebro-spinal fluid ,thus if the circulation of&#xD;
      cerebro-spinal fluid not blocked ,an increase in ICP will be transmitted through the&#xD;
      subarachnoid space around the optic nerve within the nerve sheath especially the retro-bulbar&#xD;
      segment.&#xD;
&#xD;
      The study will be conducted to monitor the dynamic changes of intracranial pressure by optic&#xD;
      nerve sheath diameter (ONSD) in response to mannitol osmotherapy as a primary outcome and&#xD;
      secondary to evaluate the efficacy of ONSD in assessing the severity of the disease&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Anticipated">November 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2019</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>
    <intervention_model_description>prospective observational study</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>No masking</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Assessing the changes in the intracranial pressure</measure>
    <time_frame>from 20 minutes before mannitol therapy (basal reading) till 48 hours after the end of mannitol infusion</time_frame>
    <description>It will be monitored and recorded the changes in intracranial pressure to the mannitol therapy .Basal (before mannitol therapy).20 minutes after the end of mannitol infusion ,2 hours ,6 hours,12 hours ,24 hours and 48 hours after the end of mannitol infusion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessing the changes in the heart rate</measure>
    <time_frame>from 20 minutes before mannitol therapy (basal reading ) till 48 hours after the end of mannitol infusion</time_frame>
    <description>It will be recorded basal (before mannitol therapy).20 minutes after the end of mannitol infusion ,2 hours ,6 hours,12 hours ,24 hours and 48 hours after the end of mannitol infusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessing the changes in the mean arterial pressure</measure>
    <time_frame>from 20 minutes before mannitol therapy(basal reading) till 48 hours after the end of mannitol infusion</time_frame>
    <description>It will be calculated according to the formula systolic blood pressure+2(diastolic blood pressure)recorded basal (before mannitol therapy).20 minutes after the end of mannitol infusion ,2 hours ,6 hours,12 hours ,24 hours and 48 hours after the end of mannitol infusion</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>Optic nerve sheath diameter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intracranial pressure will be measured by optic nerve sheath diameter while the patient in supine position with 30 -degree bed position .The linear probe in the two -dimensional mode will be placed gently on the upper eyelid without pressure .In linear horizontal orientation for both right and left optic nerve sheath will be measured</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Optic nerve sheath diameter</intervention_name>
    <description>The intracranial pressure will be measured by the optic nerve sheath diameter and after giving the mannitol osmotherapy the intracranial pressure will be monitored by the optic nerve sheath diameter</description>
    <arm_group_label>Optic nerve sheath diameter</arm_group_label>
    <other_name>ONSD</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with traumatic brain injury&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with history of optic neuritis&#xD;
&#xD;
          -  past history of eye trauma&#xD;
&#xD;
          -  patient with optic nerve trauma&#xD;
&#xD;
          -  patient with history of arachnoid cyst of the optic nerve&#xD;
&#xD;
          -  high myopic patients&#xD;
&#xD;
          -  patients with cavernous sius mass&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Reem Abdelraouf Elsharkawy</name>
      <address>
        <city>Mansourah</city>
        <state>Dakahlia</state>
        <zip>35516</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 1, 2019</study_first_submitted>
  <study_first_submitted_qc>January 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>January 5, 2019</last_update_submitted>
  <last_update_submitted_qc>January 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University Hospital</investigator_affiliation>
    <investigator_full_name>Abdelraouf Elsharkawy</investigator_full_name>
    <investigator_title>Lecturer of anesthesia and surgical intensive care</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <!-- 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/NCT03795896
org study id: Ms/15.05.88
nct id: NCT03795896
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Raised intracranial pressure (ICP) is a common and life threatening condition especially in
      patients with traumatic brain injury.There are many methods for monitoring the increased
      (ICP) either invasive or non- invasive ,but the gold standard is invasive method. Optic nerve
      sheath ultrasonography provides a very promising bedside tool for detection of increased ICP.
      This study will monitor the dynamic changes of intracranial pressure by optic nerve sheath
      diameter (ONSD) in response to mannitol osmotherapy
Traumatic brain injury is the main cause of increased intracranial pressure (ICP) in the
      intensive care .

      There are multiple methods for monitoring the raised ICP either invasive or non-invasive.The
      gold standard is the invasive devices because it is more accurate and reliable .However ,it
      requires a surgical intervention which has many hazards such as (infection
      ,hemorrhage,malfunction ).

      Optic nerve sheath ultrasonography is a promising bedside tool for detection of increased
      ICP. The optic nerve is surrounded by cerebro-spinal fluid ,thus if the circulation of
      cerebro-spinal fluid not blocked ,an increase in ICP will be transmitted through the
      subarachnoid space around the optic nerve within the nerve sheath especially the retro-bulbar
      segment.

      The study will be conducted to monitor the dynamic changes of intracranial pressure by optic
      nerve sheath diameter (ONSD) in response to mannitol osmotherapy as a primary outcome and
      secondary to evaluate the efficacy of ONSD in assessing the severity of the disease
allocation: N/A
intervention model: Single Group Assignment
intervention model description: prospective observational study
primary purpose: Diagnostic
masking: None (Open Label)
masking description: No masking
measure: Assessing the changes in the intracranial pressure
time frame: from 20 minutes before mannitol therapy (basal reading) till 48 hours after the end of mannitol infusion
description: It will be monitored and recorded the changes in intracranial pressure to the mannitol therapy .Basal (before mannitol therapy).20 minutes after the end of mannitol infusion ,2 hours ,6 hours,12 hours ,24 hours and 48 hours after the end of mannitol infusion
measure: Assessing the changes in the heart rate
time frame: from 20 minutes before mannitol therapy (basal reading ) till 48 hours after the end of mannitol infusion
description: It will be recorded basal (before mannitol therapy).20 minutes after the end of mannitol infusion ,2 hours ,6 hours,12 hours ,24 hours and 48 hours after the end of mannitol infusion
measure: Assessing the changes in the mean arterial pressure
time frame: from 20 minutes before mannitol therapy(basal reading) till 48 hours after the end of mannitol infusion
description: It will be calculated according to the formula systolic blood pressure+2(diastolic blood pressure)recorded basal (before mannitol therapy).20 minutes after the end of mannitol infusion ,2 hours ,6 hours,12 hours ,24 hours and 48 hours after the end of mannitol infusion
arm group label: Optic nerve sheath diameter
arm group type: Experimental
description: The intracranial pressure will be measured by optic nerve sheath diameter while the patient in supine position with 30 -degree bed position .The linear probe in the two -dimensional mode will be placed gently on the upper eyelid without pressure .In linear horizontal orientation for both right and left optic nerve sheath will be measured
intervention type: Diagnostic Test
intervention name: Optic nerve sheath diameter
description: The intracranial pressure will be measured by the optic nerve sheath diameter and after giving the mannitol osmotherapy the intracranial pressure will be monitored by the optic nerve sheath diameter
arm group label: Optic nerve sheath diameter
other name: ONSD
criteria: 
gender: All
minimum age: 21 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Mansoura University Hospital
investigator full name: Abdelraouf Elsharkawy
investigator title: Lecturer of anesthesia and surgical intensive care
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Wounds and Injuries