<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/NCT02240394</url>
  </required_header>
  <id_info>
    <org_study_id>Shanghai6thPeoplesH</org_study_id>
    <nct_id>NCT02240394</nct_id>
  </id_info>
  <brief_title>TCD Detection of Ophthalmic Artery Blood Flow Velocity Prediction Feasibility Study of Intracranial Pressure</brief_title>
  <official_title>TCD Detection of Ophthalmic Artery Blood Flow Velocity Prediction Feasibility Study of Intracranial Pressure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Jiao Tong University Affiliated Sixth People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Jiao Tong University Affiliated Sixth People's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Increased intracranial pressure is a cause of disease progression in patients with brain&#xD;
      disease, a common cause of poor prognosis. Intracranial pressure monitoring is the&#xD;
      observation of the disease, treatment, evaluation and important way to improve the prognosis.&#xD;
      Non-invasive intracranial pressure monitoring can be used to stroke, intracranial hemorrhage,&#xD;
      brain trauma, encephalitis and other patients. Ophthalmic artery originated from the internal&#xD;
      carotid artery, the optic canal into the orbit, the entire process can be divided into&#xD;
      intracranial optic tube segment and orbital segment. investigators' preliminary experiments&#xD;
      show that when intracranial pressure, intracranial ophthalmic artery segment velocity&#xD;
      increases with increasing velocity difference orbital segment. Accordingly, the investigators&#xD;
      speculate, may be judged by the level of intracranial pressure intracranial and orbital&#xD;
      velocity difference between the ophthalmic artery segment, and accordingly calculate the&#xD;
      specific values of intracranial pressure. The investigators will collect brain trauma&#xD;
      surgery, performed invasive intracranial pressure monitoring cases, the use of transcranial&#xD;
      Doppler ultrasound velocity and different segments of the ophthalmic artery pulsatility&#xD;
      index, the invasive intracranial pressure and comparing the measured values to calculate the&#xD;
      the critical value of the ophthalmic artery segment intraorbital and intracranial velocity&#xD;
      difference when intracranial pressure, thus fitting Based on projections of mathematical&#xD;
      formulas intracranial pressure. This study will provide a non-invasive intracranial pressure&#xD;
      monitor new approach.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      2014/08/28&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>March 2014</start_date>
  <completion_date type="Anticipated">March 2015</completion_date>
  <primary_completion_date type="Anticipated">March 2015</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>Ophthalmic artery blood flow rate changes associated with intracranial pressure</measure>
    <time_frame>&quot;up to 6 months&quot;</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>the change of the Ophthalmic artery peak sistolic velocity associated with intracranial pressure</measure>
    <time_frame>&quot;up to 6 months&quot;</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>the change of the Ophthalmic artery end diastolic velocity associated with intracranial pressure</measure>
    <time_frame>&quot;up to 6 months&quot;</time_frame>
  </other_outcome>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <condition>Cerebral Hemorrhage</condition>
  <condition>Increased Intracranial Pressure</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Traumatic brain injury patients has been in patients with invasive intracranial pressure&#xD;
        monitoring&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age 18-75 years of age (including 18 and 75 years), gender, ethnic limitation;&#xD;
&#xD;
          2. have been carried out invasive intracranial pressure monitoring;&#xD;
&#xD;
          3. the patient or his agent informed consent. -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. the patient does not fit, measured by TCD can not be completed;&#xD;
&#xD;
          2. TCD failed to detect the satisfaction of the ophthalmic artery flow signals were;&#xD;
&#xD;
          3. patients with ocular trauma or a history of intraocular pressure -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wang X Ming, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>World Health Organization</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NCU</name>
      <address>
        <city>ShangHai</city>
        <state>Shanghai</state>
        <zip>200030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Ragauskas A, Matijosaitis V, Zakelis R, Petrikonis K, Rastenyte D, Piper I, Daubaris G. Clinical assessment of noninvasive intracranial pressure absolute value measurement method. Neurology. 2012 May 22;78(21):1684-91. doi: 10.1212/WNL.0b013e3182574f50. Epub 2012 May 9.</citation>
    <PMID>22573638</PMID>
  </reference>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <last_update_submitted>February 10, 2015</last_update_submitted>
  <last_update_submitted_qc>February 10, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 11, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Jiao Tong University Affiliated Sixth People's Hospital</investigator_affiliation>
    <investigator_full_name>Xueming Wang</investigator_full_name>
    <investigator_title>Chief Physician</investigator_title>
  </responsible_party>
  <keyword>TCD Traumatic brain injury increased intracranial pressure</keyword>
  <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>Cerebral Hemorrhage</mesh_term>
    <mesh_term>Intracranial Hypertension</mesh_term>
    <mesh_term>Hemorrhage</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/NCT02240394
org study id: Shanghai6thPeoplesH
nct id: NCT02240394
lead sponsor: 
has dmc: Yes
Increased intracranial pressure is a cause of disease progression in patients with brain
      disease, a common cause of poor prognosis. Intracranial pressure monitoring is the
      observation of the disease, treatment, evaluation and important way to improve the prognosis.
      Non-invasive intracranial pressure monitoring can be used to stroke, intracranial hemorrhage,
      brain trauma, encephalitis and other patients. Ophthalmic artery originated from the internal
      carotid artery, the optic canal into the orbit, the entire process can be divided into
      intracranial optic tube segment and orbital segment. investigators' preliminary experiments
      show that when intracranial pressure, intracranial ophthalmic artery segment velocity
      increases with increasing velocity difference orbital segment. Accordingly, the investigators
      speculate, may be judged by the level of intracranial pressure intracranial and orbital
      velocity difference between the ophthalmic artery segment, and accordingly calculate the
      specific values of intracranial pressure. The investigators will collect brain trauma
      surgery, performed invasive intracranial pressure monitoring cases, the use of transcranial
      Doppler ultrasound velocity and different segments of the ophthalmic artery pulsatility
      index, the invasive intracranial pressure and comparing the measured values to calculate the
      the critical value of the ophthalmic artery segment intraorbital and intracranial velocity
      difference when intracranial pressure, thus fitting Based on projections of mathematical
      formulas intracranial pressure. This study will provide a non-invasive intracranial pressure
      monitor new approach.
2014/08/28
observational model: Cohort
time perspective: Prospective
measure: Ophthalmic artery blood flow rate changes associated with intracranial pressure
time frame: "up to 6 months"
measure: the change of the Ophthalmic artery peak sistolic velocity associated with intracranial pressure
time frame: "up to 6 months"
measure: the change of the Ophthalmic artery end diastolic velocity associated with intracranial pressure
time frame: "up to 6 months"
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Wang X Ming, Dr.
role: Principal Investigator
affiliation: World Health Organization
facility: 
country: China
citation: Ragauskas A, Matijosaitis V, Zakelis R, Petrikonis K, Rastenyte D, Piper I, Daubaris G. Clinical assessment of noninvasive intracranial pressure absolute value measurement method. Neurology. 2012 May 22;78(21):1684-91. doi: 10.1212/WNL.0b013e3182574f50. Epub 2012 May 9.
PMID: 22573638
responsible party type: Principal Investigator
investigator affiliation: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
investigator full name: Xueming Wang
investigator title: Chief Physician
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Cerebral Hemorrhage
mesh term: Intracranial Hypertension
mesh term: Hemorrhage