<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/NCT03823430</url>
  </required_header>
  <id_info>
    <org_study_id>3-2018-CLAMP</org_study_id>
    <nct_id>NCT03823430</nct_id>
  </id_info>
  <brief_title>Pupillometry : Predictive Indicator in External Ventricular Drain Clamping ?</brief_title>
  <acronym>CLAMP</acronym>
  <official_title>Pupillometry : Predictive Indicator in External Ventricular Drain Clamping ?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Association Pro-arte</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Association Pro-arte</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>
      Pupillar diameter variation to predict success or failure of external ventricular derivation&#xD;
      clamping.&#xD;
&#xD;
      Pupillometry utilisation as a diagnostic tool in external ventricular clamping test in&#xD;
      neurological ICU should improve patients care in several ways :&#xD;
&#xD;
        -  earlier use of ventriculo-peritoneal or ventriculo-atrial shunts to shorten the external&#xD;
           ventricular treatment duration and thus reduce risks of infection and hospital stay&#xD;
           duration&#xD;
&#xD;
        -  limit the medical imagery prescription and radiation exposition&#xD;
&#xD;
        -  avoid neurological deterioration linked to the external ventricular drain clamping in&#xD;
           case of the pupillometric parameters variation would be earlier than clinical signs&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 11, 2018</start_date>
  <completion_date type="Actual">March 11, 2021</completion_date>
  <primary_completion_date type="Actual">January 2, 2021</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>Pupillar diameter variation to predict success or failure of external ventricular clamping</measure>
    <time_frame>24 hours after clamping</time_frame>
    <description>Pupillar diameter variation twenty-four hours after external ventricular drain clamping</description>
  </primary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Brain Damage</condition>
  <condition>External Ventricular Drain</condition>
  <condition>Hydrocephalus</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Pupillometry</intervention_name>
    <description>Pupillar diameter variation measurement</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Any patient with an external ventricular drain in neurologic ICU can be recruited in the&#xD;
        study if all the eligibility criteria are met.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Neurologic ICU hospitalization&#xD;
&#xD;
          -  Traumatic brain injury&#xD;
&#xD;
          -  External ventricular drain&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Legal protection&#xD;
&#xD;
          -  refusal&#xD;
&#xD;
          -  therapeutics limitation&#xD;
&#xD;
          -  craniectomy&#xD;
&#xD;
          -  pupillar anomaly&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU Clermont Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Grenoble Alpes</name>
      <address>
        <city>Grenoble</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>February 15, 2022</last_update_submitted>
  <last_update_submitted_qc>February 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydrocephalus</mesh_term>
    <mesh_term>Brain Injuries</mesh_term>
  </condition_browse>
  <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/NCT03823430
org study id: 3-2018-CLAMP
nct id: NCT03823430
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pupillar diameter variation to predict success or failure of external ventricular derivation
      clamping.

      Pupillometry utilisation as a diagnostic tool in external ventricular clamping test in
      neurological ICU should improve patients care in several ways :

        -  earlier use of ventriculo-peritoneal or ventriculo-atrial shunts to shorten the external
           ventricular treatment duration and thus reduce risks of infection and hospital stay
           duration

        -  limit the medical imagery prescription and radiation exposition

        -  avoid neurological deterioration linked to the external ventricular drain clamping in
           case of the pupillometric parameters variation would be earlier than clinical signs
observational model: Cohort
time perspective: Prospective
measure: Pupillar diameter variation to predict success or failure of external ventricular clamping
time frame: 24 hours after clamping
description: Pupillar diameter variation twenty-four hours after external ventricular drain clamping
intervention type: Diagnostic Test
intervention name: Pupillometry
description: Pupillar diameter variation measurement
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Hydrocephalus
mesh term: Brain Injuries
sharing ipd: No