<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/NCT03827421</url>
  </required_header>
  <id_info>
    <org_study_id>38RC18.211</org_study_id>
    <secondary_id>2018-A02346-49</secondary_id>
    <nct_id>NCT03827421</nct_id>
  </id_info>
  <brief_title>Junior Emergency Physician Learning Curve to Perform Transcranial Doppler on Brain-damage Patients</brief_title>
  <acronym>Transcranius</acronym>
  <official_title>Transcranius : Junior Emergency Physician Learning Curve to Perform Transcranial Doppler on Brain-damage Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Grenoble</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>
      Transcranial Doppler is a noninvasive tool. Using velocity measurements and pulsatility index&#xD;
      it allows the evaluation of cerebral haemodynamics. In patients presenting brain injury&#xD;
      cerebral perfusion may be impaired. Indirect cerebral blood flow can be monitored and risk of&#xD;
      neurological worsening can be detected using transcranial Doppler. Education and performance&#xD;
      of emergency physicians must be evaluated on brain-injured patients because this tool is&#xD;
      operator dependent. The main objective of this study is to estimate the average number of&#xD;
      exams required to learn transcranial Doppler within junior emergency physicians with the&#xD;
      achievement of their learning curve. We will perform a prospective, monocentric,&#xD;
      observational study within the neurosurgical resuscitation department of Grenoble Alpes&#xD;
      University Hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The transcranial dopplers will be carry out on 75 brain-damaged patients by 13 emergency&#xD;
      residents physicians after a theoretical and practical training. They will be evaluated by 8&#xD;
      experts. The primary endpoint will be the mean number of transcranial dopplers required to&#xD;
      have an excellent concordance between resident and expert. The concordance between the&#xD;
      Doppler findings of the resident and the expert would exceed 0.8 before 30 examinations. The&#xD;
      learning curve assessed on the duration necessary to acquire good quality data should&#xD;
      decrease rapidly with the repetition of the examinations. Validating the transcranial Doppler&#xD;
      learning curve for junior emergency physician would allow them to perform this exam safely&#xD;
      and efficiently. Transcranial Doppler may be easy and fast to learn but the persistence of&#xD;
      its competency over time should be evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Organizational reasons and lack of enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">December 18, 2018</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Months</target_duration>
  <primary_outcome>
    <measure>The mean number of transcranial doppler required to reach a kappa over 0,8 between the conclusions of the resident and expert.</measure>
    <time_frame>3 months</time_frame>
    <description>Learning curve</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration in seconds for the junior to achieve the transcranial doppler</measure>
    <time_frame>3 months</time_frame>
    <description>Time between the beginning of the exam (ultrasound probe caring) to the velocities and pulsatility index measurements</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of the spectral envelope quality</measure>
    <time_frame>3 months</time_frame>
    <description>analysis of the plot of spectral envelope: good or bad</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of the evolution of the estimated difficulty of transcranial doppler realization</measure>
    <time_frame>3 months</time_frame>
    <description>evaluation of the difficulty of transcranial doppler realization: easy or difficult</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of the failure to perform the transcranial doppler</measure>
    <time_frame>10 minutes</time_frame>
    <description>number of failures to perform the transcranial doppler after 10 minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of the diastolic velocities and pulsatility index concordance between junior and expert</measure>
    <time_frame>3 months</time_frame>
    <description>number of examen required for junior velocities measurement to reach those of the expert</description>
  </secondary_outcome>
  <enrollment type="Actual">33</enrollment>
  <condition>Brain Damage</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Brain-damaged patients hospitalized in neurosurgical resuscitation or intensive care unit.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients : ≥ 18 year and older&#xD;
&#xD;
          -  Hospitalized in the neurosurgical resuscitation or intensive care unit&#xD;
&#xD;
          -  Brain - damaged patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any craniotemporal lesion impeding satisfactory TDC examination : no transtemporal&#xD;
             doppler window, patient with craniectomy.&#xD;
&#xD;
          -  Patient with meningo-encephalitis&#xD;
&#xD;
          -  Patient with cerebral vasculitis&#xD;
&#xD;
          -  Patient without health insurance coverage&#xD;
&#xD;
          -  Patient subject to a legal protection measure&#xD;
&#xD;
          -  Pregnant woman , parturient or nursing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Batistin MARTINON, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Grenoble</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Grenoble</name>
      <address>
        <city>Grenoble</city>
        <state>Auvergne Rhonalpes</state>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>March 30, 2021</last_update_submitted>
  <last_update_submitted_qc>March 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>transcranial doppler</keyword>
  <keyword>learning curve</keyword>
  <keyword>emergency</keyword>
  <keyword>traumatic brain injury</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Emergencies</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/NCT03827421
org study id: 38RC18.211
secondary id: 2018-A02346-49
nct id: NCT03827421
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Transcranial Doppler is a noninvasive tool. Using velocity measurements and pulsatility index
      it allows the evaluation of cerebral haemodynamics. In patients presenting brain injury
      cerebral perfusion may be impaired. Indirect cerebral blood flow can be monitored and risk of
      neurological worsening can be detected using transcranial Doppler. Education and performance
      of emergency physicians must be evaluated on brain-injured patients because this tool is
      operator dependent. The main objective of this study is to estimate the average number of
      exams required to learn transcranial Doppler within junior emergency physicians with the
      achievement of their learning curve. We will perform a prospective, monocentric,
      observational study within the neurosurgical resuscitation department of Grenoble Alpes
      University Hospital.
The transcranial dopplers will be carry out on 75 brain-damaged patients by 13 emergency
      residents physicians after a theoretical and practical training. They will be evaluated by 8
      experts. The primary endpoint will be the mean number of transcranial dopplers required to
      have an excellent concordance between resident and expert. The concordance between the
      Doppler findings of the resident and the expert would exceed 0.8 before 30 examinations. The
      learning curve assessed on the duration necessary to acquire good quality data should
      decrease rapidly with the repetition of the examinations. Validating the transcranial Doppler
      learning curve for junior emergency physician would allow them to perform this exam safely
      and efficiently. Transcranial Doppler may be easy and fast to learn but the persistence of
      its competency over time should be evaluated.
observational model: Other
time perspective: Prospective
measure: The mean number of transcranial doppler required to reach a kappa over 0,8 between the conclusions of the resident and expert.
time frame: 3 months
description: Learning curve
measure: Duration in seconds for the junior to achieve the transcranial doppler
time frame: 3 months
description: Time between the beginning of the exam (ultrasound probe caring) to the velocities and pulsatility index measurements
measure: Analysis of the spectral envelope quality
time frame: 3 months
description: analysis of the plot of spectral envelope: good or bad
measure: Analysis of the evolution of the estimated difficulty of transcranial doppler realization
time frame: 3 months
description: evaluation of the difficulty of transcranial doppler realization: easy or difficult
measure: Analysis of the failure to perform the transcranial doppler
time frame: 10 minutes
description: number of failures to perform the transcranial doppler after 10 minutes
measure: Analysis of the diastolic velocities and pulsatility index concordance between junior and expert
time frame: 3 months
description: number of examen required for junior velocities measurement to reach those of the expert
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Batistin MARTINON, MD
role: Principal Investigator
affiliation: University Hospital, Grenoble
facility: 
country: France
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Emergencies
sharing ipd: No