<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/NCT04507620</url>
  </required_header>
  <id_info>
    <org_study_id>33935/7/20</org_study_id>
    <nct_id>NCT04507620</nct_id>
  </id_info>
  <brief_title>Effect of Cervical Immobilization on Optic Nerve Sheath Diameter</brief_title>
  <official_title>Effect of Cervical Neck Collar and Head Blocks Strapped on the Backboard on Optic Nerve Sheath Diameter</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tanta University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tanta University</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>
      Effect of Cervical Immobilization on Optic Nerve Sheath Diameter&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Two cervical immobilization devices will be used in this study named cervical neck collar and&#xD;
      head blocks strapped on the backboard and optic nerve diameter will be measured using point&#xD;
      of care ultrasound and compare the effect of each type of cervical immobilisation on optic&#xD;
      nerve sheath diameter.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 8, 2020</start_date>
  <completion_date type="Anticipated">November 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>Effect of cervical neck collar and head blocks strapped on the backboard on Optic Nerve Sheath Diameter</measure>
    <time_frame>6 month</time_frame>
    <description>effect of cervical neck collar and head blocks strapped on the backboard on optic nerve sheath diameter, measured by point of care ultrasound</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Optic Nerve Sheath Diameter</condition>
  <condition>Point of Care Ultrasound</condition>
  <arm_group>
    <arm_group_label>cervical neck collar</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>head blocks strapped on the backboard</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>cervical neck collar</intervention_name>
    <description>devices used for cervical immobilization</description>
    <arm_group_label>cervical neck collar</arm_group_label>
    <arm_group_label>head blocks strapped on the backboard</arm_group_label>
    <other_name>head blocks strapped on the backboard</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This prospective study will be done on 100 medical students, emergency medicine and&#xD;
        traumatology residents and assistant lecturers ,Tanta university faculty of medicine,&#xD;
        healthy volunteers during a period of 6 months.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult healthy volunteers aged more than 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hx of stroke&#xD;
&#xD;
               -  Inability to consent,&#xD;
&#xD;
               -  Inability to lay flat on a bed or table for 15 min in duration,&#xD;
&#xD;
               -  History of glaucoma, globe injury, lens implant,&#xD;
&#xD;
               -  Recent refractive surgery (within the past 60 days).&#xD;
&#xD;
               -  Uncontrolled hypertension&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Mohamed Elbahnasawy</name>
      <address>
        <city>Tanta</city>
        <state>Gharbia</state>
        <zip>31527</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohamed G Elbahnasawy, MD</last_name>
      <phone>01091291077</phone>
      <phone_ext>+20</phone_ext>
      <email>drmogabehn@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 6, 2020</study_first_submitted>
  <study_first_submitted_qc>August 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2020</study_first_posted>
  <last_update_submitted>August 9, 2020</last_update_submitted>
  <last_update_submitted_qc>August 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tanta University</investigator_affiliation>
    <investigator_full_name>Mohamed Elbahnasawy, MD</investigator_full_name>
    <investigator_title>consultant of emergency medicine and traumatology</investigator_title>
  </responsible_party>
  <keyword>cervical immobilization</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/NCT04507620
org study id: 33935/7/20
nct id: NCT04507620
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Effect of Cervical Immobilization on Optic Nerve Sheath Diameter
Two cervical immobilization devices will be used in this study named cervical neck collar and
      head blocks strapped on the backboard and optic nerve diameter will be measured using point
      of care ultrasound and compare the effect of each type of cervical immobilisation on optic
      nerve sheath diameter.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Effect of cervical neck collar and head blocks strapped on the backboard on Optic Nerve Sheath Diameter
time frame: 6 month
description: effect of cervical neck collar and head blocks strapped on the backboard on optic nerve sheath diameter, measured by point of care ultrasound
arm group label: cervical neck collar
arm group label: head blocks strapped on the backboard
intervention type: Device
intervention name: cervical neck collar
description: devices used for cervical immobilization
arm group label: cervical neck collar
arm group label: head blocks strapped on the backboard
other name: head blocks strapped on the backboard
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Tanta University
investigator full name: Mohamed Elbahnasawy, MD
investigator title: consultant of emergency medicine and traumatology
sharing ipd: No