<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/NCT03766451</url>
  </required_header>
  <id_info>
    <org_study_id>Hebatullah Negm Eldeen</org_study_id>
    <nct_id>NCT03766451</nct_id>
  </id_info>
  <brief_title>Noninvasive Assessment of Intravascular Volume Status for Postoperative Patients</brief_title>
  <official_title>Noninvasive Assessment of Intravascular Volume Status for Postoperative Patients: The Correlation Between Internal Jugular Vein/Common Carotid Artery Cross-Sectional Area Ratio and the Inferior Vena Cava Diameter</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beni-Suef University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beni-Suef University</source>
  <brief_summary>
    <textblock>
      Ultrasound measurements of the inferior vena cava (IVC) have been proposed as a noninvasive&#xD;
      tool to help guide fluid management. Well-established correlations exist between respiratory&#xD;
      cycle-induced changes in IVC diameter and C entral Venous Pressure (CVP) . Beyond providing&#xD;
      an estimate of CVP, the caval index, or percentage collapsibility of the IVC , has been&#xD;
      proposed as a predictor of preload reserve. This noninvasive rapid measurement of CVP is&#xD;
      especially important in critical care settings. It can help in differentiating hypovolemic,&#xD;
      septic and cardiogenic shock. Changes in volume status will be depicted by change in the&#xD;
      diameter of the IVC .&#xD;
&#xD;
      However, the validity and reliability of sonographic assessment of the inferior vena cava&#xD;
      have been matters of controversy, and its applicability has been shown to be limited by&#xD;
      technical difficulties. Recent study has shown a significant relationship between the&#xD;
      internal jugular vein/common carotid artery (IJV/CCA) cross-sectional area ratio and CVP in&#xD;
      pediatric burn patients .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Type and Site of The study:&#xD;
&#xD;
      This study will be be done at Beni-Suef university hospital ,Surgical Intensive Care Unit&#xD;
      (SICU) after approval of the local ethics and research committee and anesthesia department of&#xD;
      Beni- Suef University.&#xD;
&#xD;
      DATE AND PERIOD OF THE STUDY:&#xD;
&#xD;
      The study will be done between NOV. 2018 and Nov. 2019&#xD;
&#xD;
      Patients will be included:&#xD;
&#xD;
      Patients scheduled for elective or emergency major surgeries (e.g., abdominal exploration,&#xD;
      cancer bladder, cancer rectum, cancer stomach and aorto-femoral bypass grafting) who require&#xD;
      post-operative SICU admission for close monitoring and assessment of volume status will be&#xD;
      considered for enrollment.&#xD;
&#xD;
      Thirty five patients will be enrolled in the study; the patients will be admitted to the&#xD;
      post-surgical intensive care unit for post-operative close observation and monitoring for at&#xD;
      least 24 h. Upon admission, baseline laboratory investigation, chest x-ray, Arterial Blood&#xD;
      Gases (ABG) and vital signs (hear rate, mean arterial blood pressure, arterial oxygen&#xD;
      saturation and temperature) will be all measured.&#xD;
&#xD;
      Patients will get nurse-controlled analgesia using morphine boluses of 1-2 mg intravenously,&#xD;
      followed by a continuous infusion of 1 or 2 mg/h according to the protocol of the SICU team.&#xD;
      CVP, sonographic measurement of (IJV/CCA) cross sectional area ratio and IVC diameter will be&#xD;
      measured after admitting the patient to SICU as a baseline reading, second measurements will&#xD;
      be after achieving CVP between (8-12 cmH2O).&#xD;
&#xD;
      Data to be collected and measured&#xD;
&#xD;
      Demographic data will be obtained from patient's notes and charts including&#xD;
&#xD;
      1- Age, sex, body mass index, ASA physical status and type of surgery.&#xD;
&#xD;
      Cardiorespiratory variables of the Patients include:&#xD;
&#xD;
        -  CVP (CMH2O),&#xD;
&#xD;
        -  Heart rate (beats/min),&#xD;
&#xD;
        -  MAP( mmHg),&#xD;
&#xD;
        -  Oxygen saturation (spo2 %),&#xD;
&#xD;
        -  Urine output (ml/h),&#xD;
&#xD;
      IVC measurements include:&#xD;
&#xD;
        -  IVC Maximum Diameter (cm).&#xD;
&#xD;
        -  IVC Minimum Diameter (cm).&#xD;
&#xD;
      Internal jugular vein and common carotid artery measurements include:&#xD;
&#xD;
        -  CCA Surface&#xD;
&#xD;
        -  IJV surface at inspiration&#xD;
&#xD;
        -  IJV surface at expiration&#xD;
&#xD;
        -  IJV/CCA RATIO at inspiration&#xD;
&#xD;
        -  IJV/CCA RATIO at expiration&#xD;
&#xD;
      Data will be measured after admitting the patient to SICU as a baseline reading, second&#xD;
      measurements will be after achieving CVP between (8-12 cmH2O).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 10, 2018</start_date>
  <completion_date type="Anticipated">November 2019</completion_date>
  <primary_completion_date type="Anticipated">November 2019</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>The correlation between (Internal Jugular Vein/Common Carotid Artery Cross-Sectional Area Ratio),and Inferior Vena Cava Diameter by using ultrasound</measure>
    <time_frame>immediately upon admission to surgical intensive care unit and after acchieving cvp above 8 cmh2o by saline infusion (10 ml/kg) average 3 hours after admission</time_frame>
    <description>The correlation between (Internal Jugular Vein/Common Carotid Artery Cross-Sectional Area Ratio),and Inferior Vena Cava Diameter by using ultrasound</description>
  </primary_outcome>
  <enrollment type="Anticipated">35</enrollment>
  <condition>Intravascular Volume</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients scheduled for elective or emergency major surgeries (e.g., abdominal exploration,&#xD;
        cancer bladder, cancer rectum, cancer stomach and aorto-femoral bypass grafting) who&#xD;
        require post-operative SICU admission for close monitoring and assessment of volume status&#xD;
        will be considered for enrollment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:.&#xD;
&#xD;
          1. ASA physical status I and II&#xD;
&#xD;
          2. Patients who are able to breathe spontaneously and lay supine post-operative.&#xD;
&#xD;
          3. Patients who had CVP catheter (subclavian or internal jugular vein)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1- Chronic obstructive or restrictive pulmonary disease. 2-Significant cardiac disease&#xD;
             3-Significant hepatic disease 4-Renal impairment ( creatinine &gt;2 mg/dl). 5- BMI ˃ 30&#xD;
             kg/m2 6- Pneumothorax or mediastinal masses. 7- mechanical ventilation or coming with&#xD;
             tracheostomy. 8- defect at the site of sonography. 9- Pregnancy. 10- Instability of&#xD;
             vital signs 11- Unwillingness to participate 12- sepsis or septic shock. 13-&#xD;
             neurosurgical interventions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Hebatullah Negm eldeen, A.L.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beni-Suef University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hebatullah Negm Eldeen</name>
      <address>
        <city>Banī Suwayf</city>
        <zip>11311</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>samaa rashwan, A.P</last_name>
      <phone>01208929154</phone>
      <email>samaarashwan1971@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Ahmed Goda, MD</last_name>
      <phone>01111861863</phone>
      <email>Abogoda100100@yahoo.com</email>
    </contact_backup>
    <investigator>
      <last_name>Hebatullah Negm el deen, A.L</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>December 4, 2018</last_update_submitted>
  <last_update_submitted_qc>December 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beni-Suef University</investigator_affiliation>
    <investigator_full_name>Hebatullah Negm Eldeen Abd El Azeem</investigator_full_name>
    <investigator_title>Assistant lecturer</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/NCT03766451
org study id: Hebatullah Negm Eldeen
nct id: NCT03766451
lead sponsor: 
Ultrasound measurements of the inferior vena cava (IVC) have been proposed as a noninvasive
      tool to help guide fluid management. Well-established correlations exist between respiratory
      cycle-induced changes in IVC diameter and C entral Venous Pressure (CVP) . Beyond providing
      an estimate of CVP, the caval index, or percentage collapsibility of the IVC , has been
      proposed as a predictor of preload reserve. This noninvasive rapid measurement of CVP is
      especially important in critical care settings. It can help in differentiating hypovolemic,
      septic and cardiogenic shock. Changes in volume status will be depicted by change in the
      diameter of the IVC .

      However, the validity and reliability of sonographic assessment of the inferior vena cava
      have been matters of controversy, and its applicability has been shown to be limited by
      technical difficulties. Recent study has shown a significant relationship between the
      internal jugular vein/common carotid artery (IJV/CCA) cross-sectional area ratio and CVP in
      pediatric burn patients .
Type and Site of The study:

      This study will be be done at Beni-Suef university hospital ,Surgical Intensive Care Unit
      (SICU) after approval of the local ethics and research committee and anesthesia department of
      Beni- Suef University.

      DATE AND PERIOD OF THE STUDY:

      The study will be done between NOV. 2018 and Nov. 2019

      Patients will be included:

      Patients scheduled for elective or emergency major surgeries (e.g., abdominal exploration,
      cancer bladder, cancer rectum, cancer stomach and aorto-femoral bypass grafting) who require
      post-operative SICU admission for close monitoring and assessment of volume status will be
      considered for enrollment.

      Thirty five patients will be enrolled in the study; the patients will be admitted to the
      post-surgical intensive care unit for post-operative close observation and monitoring for at
      least 24 h. Upon admission, baseline laboratory investigation, chest x-ray, Arterial Blood
      Gases (ABG) and vital signs (hear rate, mean arterial blood pressure, arterial oxygen
      saturation and temperature) will be all measured.

      Patients will get nurse-controlled analgesia using morphine boluses of 1-2 mg intravenously,
      followed by a continuous infusion of 1 or 2 mg/h according to the protocol of the SICU team.
      CVP, sonographic measurement of (IJV/CCA) cross sectional area ratio and IVC diameter will be
      measured after admitting the patient to SICU as a baseline reading, second measurements will
      be after achieving CVP between (8-12 cmH2O).

      Data to be collected and measured

      Demographic data will be obtained from patient's notes and charts including

      1- Age, sex, body mass index, ASA physical status and type of surgery.

      Cardiorespiratory variables of the Patients include:

        -  CVP (CMH2O),

        -  Heart rate (beats/min),

        -  MAP( mmHg),

        -  Oxygen saturation (spo2 %),

        -  Urine output (ml/h),

      IVC measurements include:

        -  IVC Maximum Diameter (cm).

        -  IVC Minimum Diameter (cm).

      Internal jugular vein and common carotid artery measurements include:

        -  CCA Surface

        -  IJV surface at inspiration

        -  IJV surface at expiration

        -  IJV/CCA RATIO at inspiration

        -  IJV/CCA RATIO at expiration

      Data will be measured after admitting the patient to SICU as a baseline reading, second
      measurements will be after achieving CVP between (8-12 cmH2O).
observational model: Other
time perspective: Prospective
measure: The correlation between (Internal Jugular Vein/Common Carotid Artery Cross-Sectional Area Ratio),and Inferior Vena Cava Diameter by using ultrasound
time frame: immediately upon admission to surgical intensive care unit and after acchieving cvp above 8 cmh2o by saline infusion (10 ml/kg) average 3 hours after admission
description: The correlation between (Internal Jugular Vein/Common Carotid Artery Cross-Sectional Area Ratio),and Inferior Vena Cava Diameter by using ultrasound
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
last name: Hebatullah Negm eldeen, A.L.
role: Principal Investigator
affiliation: Beni-Suef University
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Beni-Suef University
investigator full name: Hebatullah Negm Eldeen Abd El Azeem
investigator title: Assistant lecturer