xml: <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/NCT05992246</url>
    </required_header>
    <id_info>
      <org_study_id>Pediatric Fluid Responsiveness</org_study_id>
      <nct_id>NCT05992246</nct_id>
    </id_info>
    <brief_title>The Ratio of Femoral Vein Diameter to Femoral Artery Diameter to Predict Fluid Responsiveness in Children</brief_title>
    <official_title>The Validity of the Ratio of Femoral Vein Diameter to Femoral Artery Diameter to Predict Fluid Responsiveness in Children</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>Yes</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>
        The hypothesis of the study will be that the ratio of femoral vein diameter to femoral artery&#xD;
        diameter will have correlation with fluid status in pediatrics.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Proper administration of intravenous fluids is an important part of treating circulatory&#xD;
        failure in children and affects the clinical outcome of the management of the child's&#xD;
        emergency. Giving a small amount of fluid will cause tissue hypoperfusion and worsen organ&#xD;
        dysfunction and cause ischemia. On the other hand, excess fluid interferes with oxygen&#xD;
        delivary, exacerbates treatment outcomes, increases complications, and extends both the&#xD;
        length of the stay in intensive care and mortality. The use of bedside ultrasound by&#xD;
        pediatric intensive care physicians has become so critical in recent years that it is now a&#xD;
        component of physical examination in ICUs&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 20, 2023</start_date>
    <completion_date type="Anticipated">August 2024</completion_date>
    <primary_completion_date type="Anticipated">July 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Crossover</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Measurement of changes in the ratio of femoral vein diameter to femoral artery diameter</measure>
      <time_frame>immediate preoperative period before the induction of general anesthesia</time_frame>
      <description>Measurement of changes in the ratio of femoral vein diameter to femoral artery diameter before and after fluid challenge which will be defined as infusion of ringer lactate 10 ml/kg body weight over 20 min.</description>
    </primary_outcome>
    <enrollment type="Anticipated">85</enrollment>
    <condition>Pediatric ALL</condition>
    <condition>Fluid Overload</condition>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Ratio of Femoral Vein Diameter to Femoral Artery Diameter</intervention_name>
      <description>An ultrasound probe will be used to first scan the area of the upper thigh just below the inguinal ligament directing caudally seeking for the femoral vessels. The femoral artery and vein could be observed simultaneously. Under normal conditions, pulsation is an indication of the femoral artery, and its companion is the femoral vein. The mean femoral vein diameter and femoral vein diameter (3-5 diametral lines in different directions) will be measured during cough, crying, or performing the Valsalva maneuvers.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Preoperative children with ASA physical status 1-2, 2-10 years of age scheduled for&#xD;
          elective surgery with signs of moderate to severe dehydration for assessment of fluid&#xD;
          status just before induction of general anaesthesia&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  children with American society of anaesthesiologist physical status 1-2&#xD;
  &#xD;
            -  2-10 years of age&#xD;
  &#xD;
            -  scheduled for elective surgery&#xD;
  &#xD;
            -  signs of moderate to severe dehydration&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with mild dehydration.&#xD;
  &#xD;
            -  Patients with history of significant comorbid conditions or previous laparotomy.&#xD;
  &#xD;
            -  Congenital heart disease.&#xD;
  &#xD;
            -  Heart failure.&#xD;
  &#xD;
            -  Disorder of venous return like arteriovenous fistula, DVT or Varicose veins.&#xD;
  &#xD;
            -  Increase intra-abdominal pressure.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>2 Years</minimum_age>
      <maximum_age>10 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>sameh Fathi, MD</last_name>
      <role>Study Director</role>
      <affiliation>tanta university, faculty of medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>tarek A Mostafa, MD</last_name>
      <phone>+201207416231</phone>
      <email>dr.tarek311@yahoo.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Faculty of medicine, Tanta university</name>
        <address>
          <city>Tanta</city>
          <state>El Gharbyia</state>
          <zip>31111</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <contact>
        <last_name>tarek Mostafa</last_name>
        <phone>020403332033</phone>
        <email>dr.tarek311@yahoo.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tanta University</investigator_affiliation>
      <investigator_full_name>tarek abdel hay mostafa</investigator_full_name>
      <investigator_title>principle investigator</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05992246
  org study id: Pediatric Fluid Responsiveness
  nct id: NCT05992246
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The hypothesis of the study will be that the ratio of femoral vein diameter to femoral artery
        diameter will have correlation with fluid status in pediatrics.
  Proper administration of intravenous fluids is an important part of treating circulatory
        failure in children and affects the clinical outcome of the management of the child's
        emergency. Giving a small amount of fluid will cause tissue hypoperfusion and worsen organ
        dysfunction and cause ischemia. On the other hand, excess fluid interferes with oxygen
        delivary, exacerbates treatment outcomes, increases complications, and extends both the
        length of the stay in intensive care and mortality. The use of bedside ultrasound by
        pediatric intensive care physicians has become so critical in recent years that it is now a
        component of physical examination in ICUs
  observational model: Case-Crossover
  time perspective: Prospective
  measure: Measurement of changes in the ratio of femoral vein diameter to femoral artery diameter
  time frame: immediate preoperative period before the induction of general anesthesia
  description: Measurement of changes in the ratio of femoral vein diameter to femoral artery diameter before and after fluid challenge which will be defined as infusion of ringer lactate 10 ml/kg body weight over 20 min.
  intervention type: Diagnostic Test
  intervention name: Ratio of Femoral Vein Diameter to Femoral Artery Diameter
  description: An ultrasound probe will be used to first scan the area of the upper thigh just below the inguinal ligament directing caudally seeking for the femoral vessels. The femoral artery and vein could be observed simultaneously. Under normal conditions, pulsation is an indication of the femoral artery, and its companion is the femoral vein. The mean femoral vein diameter and femoral vein diameter (3-5 diametral lines in different directions) will be measured during cough, crying, or performing the Valsalva maneuvers.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 2 Years
  maximum age: 10 Years
  healthy volunteers: No
  last name: sameh Fathi, MD
  role: Study Director
  affiliation: tanta university, faculty of medicine
  last name: tarek A Mostafa, MD
  phone: +201207416231
  email: dr.tarek311@yahoo.com
  facility: 
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Tanta University
  investigator full name: tarek abdel hay mostafa
  investigator title: principle investigator
  sharing ipd: No