<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/NCT03030898</url>
  </required_header>
  <id_info>
    <org_study_id>9829260098237333</org_study_id>
    <nct_id>NCT03030898</nct_id>
  </id_info>
  <brief_title>Analysis of Respiratory Variations of the Right Internal Jugular Vein as a Predictor of Fluid Responsiveness During Mechanical Ventilation</brief_title>
  <official_title>Analysis of Respiratory Variations of the Internal Jugular Vein as a Predictor of Fluid Responsiveness During Mechanical Ventilation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Military Hospital of Tunis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Military Hospital of Tunis</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>
      The idea of this work came during a carotid surgery, when we noticed a respiratory variation&#xD;
      of the right internal jugular vein. Also, because of the interest of evaluating the preload&#xD;
      dependence during an intervention or reanimation where it is difficult to access the other&#xD;
      monitoring methods . The aim of the study was to test the hypothesis that respiratory changes&#xD;
      in right internal jugular vein diameter are similar to respiratory changes in superior and&#xD;
      inferior vena cava in mechanically ventilated patients and therefore help to predict fluid&#xD;
      responsiveness.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">December 28, 2017</completion_date>
  <primary_completion_date type="Anticipated">April 25, 2017</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Respiratory Variation of the Right Internal Jugular Vein ∆DRIJV</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Difference (Δ) between the maximum and the minimum diameter value/maximum diameter .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Respiratory Variation of the superior vena cava ∆DSVC</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Difference (Δ) between the maximum and the minimum diameter value/maximum diameter .</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Respiratory Variation of the inferior vena cava ∆DIVC</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Difference (Δ) between the maximum and the minimum diameter value/minimum diameter .</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Jugular Veins</condition>
  <condition>Ultrasonography</condition>
  <arm_group>
    <arm_group_label>respiratory variation of the right internal jugular vein</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>respiratory variation of the right internal jugular vein</intervention_name>
    <description>respiratory variation of the right internal jugular vein vs respiratory variation of superior and inferior cava vena</description>
    <arm_group_label>respiratory variation of the right internal jugular vein</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  older than 18 years&#xD;
&#xD;
          -  Mechanical Ventilation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no exclusion Criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anis Lebbi</last_name>
    <role>Study Director</role>
    <affiliation>Military Hospital of Tunis</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mejdi Ferjaoui</last_name>
    <role>Principal Investigator</role>
    <affiliation>Military Hospital of Tunis</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Trabelsi Walid</last_name>
    <role>Study Chair</role>
    <affiliation>Military Hospital of Tunis</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Abdelkader Ben Gabsia</last_name>
    <role>Study Chair</role>
    <affiliation>Military Hospital of Tunis</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Emel Rafrafi</last_name>
    <role>Study Chair</role>
    <affiliation>Military Hospital of Tunis</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Amine Skouri</last_name>
    <role>Study Chair</role>
    <affiliation>Military Hospital of Tunis</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kaouther Fares</last_name>
    <role>Study Chair</role>
    <affiliation>Military Hospital of Tunis</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Walid Sallami</last_name>
    <role>Study Chair</role>
    <affiliation>Military Hospital of Tunis</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Iheb Labbene</last_name>
    <role>Study Chair</role>
    <affiliation>Military Hospital of Tunis</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mustapha Ferjani</last_name>
    <role>Study Chair</role>
    <affiliation>Military Hospital of Tunis</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>January 21, 2017</last_update_submitted>
  <last_update_submitted_qc>January 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Military Hospital of Tunis</investigator_affiliation>
    <investigator_full_name>Lebbi Anis</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT03030898
org study id: 9829260098237333
nct id: NCT03030898
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The idea of this work came during a carotid surgery, when we noticed a respiratory variation
      of the right internal jugular vein. Also, because of the interest of evaluating the preload
      dependence during an intervention or reanimation where it is difficult to access the other
      monitoring methods . The aim of the study was to test the hypothesis that respiratory changes
      in right internal jugular vein diameter are similar to respiratory changes in superior and
      inferior vena cava in mechanically ventilated patients and therefore help to predict fluid
      responsiveness.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Respiratory Variation of the Right Internal Jugular Vein ∆DRIJV
time frame: through study completion, an average of 1 year
description: Difference (Δ) between the maximum and the minimum diameter value/maximum diameter .
measure: Respiratory Variation of the superior vena cava ∆DSVC
time frame: through study completion, an average of 1 year
description: Difference (Δ) between the maximum and the minimum diameter value/maximum diameter .
measure: Respiratory Variation of the inferior vena cava ∆DIVC
time frame: through study completion, an average of 1 year
description: Difference (Δ) between the maximum and the minimum diameter value/minimum diameter .
arm group label: respiratory variation of the right internal jugular vein
arm group type: Other
intervention type: Diagnostic Test
intervention name: respiratory variation of the right internal jugular vein
description: respiratory variation of the right internal jugular vein vs respiratory variation of superior and inferior cava vena
arm group label: respiratory variation of the right internal jugular vein
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anis Lebbi
role: Study Director
affiliation: Military Hospital of Tunis
last name: Mejdi Ferjaoui
role: Principal Investigator
affiliation: Military Hospital of Tunis
last name: Trabelsi Walid
role: Study Chair
affiliation: Military Hospital of Tunis
last name: Abdelkader Ben Gabsia
role: Study Chair
affiliation: Military Hospital of Tunis
last name: Emel Rafrafi
role: Study Chair
affiliation: Military Hospital of Tunis
last name: Amine Skouri
role: Study Chair
affiliation: Military Hospital of Tunis
last name: Kaouther Fares
role: Study Chair
affiliation: Military Hospital of Tunis
last name: Walid Sallami
role: Study Chair
affiliation: Military Hospital of Tunis
last name: Iheb Labbene
role: Study Chair
affiliation: Military Hospital of Tunis
last name: Mustapha Ferjani
role: Study Chair
affiliation: Military Hospital of Tunis
responsible party type: Principal Investigator
investigator affiliation: Military Hospital of Tunis
investigator full name: Lebbi Anis
investigator title: Clinical Professor