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/NCT05980494</url>
    </required_header>
    <id_info>
      <org_study_id>D 310</org_study_id>
      <nct_id>NCT05980494</nct_id>
    </id_info>
    <brief_title>Lung Ultrasound Score and Inferior Vena Cava Diameter Compared to Pulse Pressure Variation</brief_title>
    <official_title>Validity of Lung Ultrasound Score and Inferior Vena Cava Diameter Compared to Pulse Pressure Variation Predicting Fluid Responsiveness in Mechanically Ventilated Critically Ill Patients: a Comparative Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fayoum University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fayoum University Hospital</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>
        Evaluation and management of intravascular volume are a central challenge for the critical&#xD;
        ill patients. Hypotensive patients are commonly resuscitated with intravenous crystalloid&#xD;
        fluid as a recommendation for treatment of many shock states.&#xD;
  &#xD;
        There has been a growing interest in the implementation of lung ultrasound in critical care&#xD;
        management in the last decade as it is easy, bedside, non-expensive, non invasive and&#xD;
        radiation free.&#xD;
  &#xD;
        The object of the current study is to assess the ability of lung and inferior vena cava&#xD;
        sonography versus pulse pressure variation to predict fluid responsiveness in patients with&#xD;
        circulatory failure on mechanical ventilation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study will be conducted in intensive care units of Fayoum University Hospitals after&#xD;
        approval of the local institutional ethics committee and local institutional review board.&#xD;
        Hypotensive Patients on mechanical ventilation starting from August 2022 will be enrolled in&#xD;
        this prospective study until fulfilling sample size. A detailed informed consent will be&#xD;
        signed before recruitment. All patients who fulfilled inclusion criteria will be monitored&#xD;
        by: 6 leads ECG, Blood pressure, Urinary catheter for urine output, Pulse oximter.Lung&#xD;
        ultrasound (LUS), Inferior vena cava ultrasound (IVC US) and pulse pressure variation (PPV)&#xD;
        will be done to every patient in the study. The Consolidated standards of Reporting Trials&#xD;
        (CONSORT) recommendation will be followed. LUS and IVC measurements were performed by using a&#xD;
        convex ultrasound probe (Philips clear vue350, Philips healthcare, Andover MAO1810, USA,&#xD;
        Machine ID: 1385). LUS will be performed by an experienced radiologist according to&#xD;
        standardized protocols. For each hemi-thorax 3 main areas (anterior (Ant), lateral (Lt) and&#xD;
        posterior (Post)) marked by the para-sternal, anterior axillary and posterior axillary lines&#xD;
        for a total of 28 sectors will be identified. Each one will be divided into upper and lower&#xD;
        halves, making a sum of 6 different quadrants for each side: anterior superior, anterior&#xD;
        inferior, lateral superior, lateral inferior, posterior superior, posterior inferior.&#xD;
        Ultrasound examination of the anterolateral chest was carried out with longitudinal scan of&#xD;
        the right and left hemi thoraces, from the second to the fourth (on the right side to the&#xD;
        ﬁfth) intercostal space, as previously described. For each quadrant a score will be assigned&#xD;
        based on B lines which are defined as an echogenic artifact with a narrow origin on the&#xD;
        pleural line, deepening to the inferior border of the screen and coherent with respiratory&#xD;
        movements indicating subpleural interstitial edema as follows:&#xD;
  &#xD;
        (0) Normal aeration: A lines with lung sliding or fewer than two isolated B lines&#xD;
  &#xD;
          1. Moderate loss of lung aeration: well-defined, multiple B lines.&#xD;
  &#xD;
          2. Severe loss of lung aeration: multiple coalescent B lines.&#xD;
  &#xD;
          3. Complete loss of lung aeration or lung consolidation. This will be used to calculate&#xD;
             total LUS-score (calculated as a sum of all quadrants score) and individual areas score&#xD;
             (Ant, Lt and Post).&#xD;
  &#xD;
        IVC US: The inferior vena cava was explored in the subxiphoid window in its sagittal&#xD;
        view-just below the junction between the inferior vena cava and suprahepatic veins which lie&#xD;
        approximately 0.5 to 3 cm from the right atrium, following the American Society of&#xD;
        Echocardiography guidelines.; The (IVC distensibility index (dIVC) was calculated as (maximum&#xD;
        diameter - minimum diameter)/minimum diameter.&#xD;
  &#xD;
        PPV: patients will be temporarily sedated and paralyzed and on fully controlled mechanical&#xD;
        ventilation. No spontaneous breathing effort will be detected on the mechanical ventilator&#xD;
        waveform monitor ensuring that the respiratory changes in arterial pressure reflected only&#xD;
        the effects of positive pressure ventilation. Modes of ventilation is selected to volume or&#xD;
        pressure controlled ventilation, depending on the decision of the primary physicians. A tidal&#xD;
        volume will be not less than 8 ml/ kg (predicted body weight). The preset respiratory rate&#xD;
        will be at 14 breath/min. Positive end expiratory pressure (PEEP) will be between 8 and 10&#xD;
        cmH2O. The plateau pressure was kept at below 30 cmH2O. In all patients, radial artery&#xD;
        cannulation will be done for invasive blood pressure monitoring (using a 20 G cannula), PPV&#xD;
        is calculated directly on Nihon Kohden monitores at base line.&#xD;
  &#xD;
        • Sample size: Sample size was calculated using MedCalc Statistical Software version 20&#xD;
        (MedCalc Software, Ostend, Belgium. Minimal sample size of patients was 118 patients with 59&#xD;
        responsive cases and 59 non-responsive cases. Calculation is guided by AUC of 0.915 obtained&#xD;
        from a study in comparison to a null value of 0.8, with alpha of 0.05 and power of 90%.&#xD;
        Sample size will be increased to 150 patients to increase precision and ensure that at least&#xD;
        59 responsive and 59 non-responsive cases are included.&#xD;
  &#xD;
        • Statistical analysis: Data will be collected and coded using Microsoft Excel and data&#xD;
        analysis will be performed using IBM SPSS version 28 for Windows. Descriptive statistics will&#xD;
        be presented in the form of numbers and percentages of categorical data, while means with&#xD;
        standard deviations or medians with interquartile ranges will be used for numerical data&#xD;
        variables. ROC curve will be used to estimate the appropriate cut off point for the inferior&#xD;
        vena cava distensibility index, and for the lung ultrasound score. Area under the curve (AUC)&#xD;
        will be reported and will be used to compare the diagnostic ability of different tests.&#xD;
        Sensitivity, specificity, positive predictive value and negative predictive value will be&#xD;
        reported with the 95% confidence intervals. P-value &lt; 0.05 will be considered statistically&#xD;
        significant.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 13, 2022</start_date>
    <completion_date type="Anticipated">April 20, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 20, 2024</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>The sensitivity of lung ultrasound in predicting fluid responsiveness.</measure>
      <time_frame>After 5 minutes of admission</time_frame>
      <description>&lt;0.8: non-sensitive, &gt;0.8: sensitive</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>lung ultrasound B lines score</measure>
      <time_frame>after 5 minutes of admission</time_frame>
      <description>(0) Normal aeration: A lines with lung sliding or fewer than two isolated B lines&#xD;
  Moderate loss of lung aeration: well-defined, multiple B lines.&#xD;
  Severe loss of lung aeration: multiple coalescent B lines.&#xD;
  Complete loss of lung aeration or lung consolidation. This will be used to calculate total LUS-score (calculated as a sum of all quadrants score) and individual areas score (Ant, Lt and Post).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Inferior vena cava distensibility index.</measure>
      <time_frame>after 10 minutes of admission</time_frame>
      <description>(maximum diameter - minimum diameter)/minimum diameter.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pulse pressure variation</measure>
      <time_frame>15 minutes after admission</time_frame>
      <description>in percent</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>central venous pressure</measure>
      <time_frame>after 20 minutes of admission</time_frame>
      <description>in centimeter water</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>heart rate</measure>
      <time_frame>5 minutes after admission</time_frame>
      <description>in beat per minute</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>serum lactate</measure>
      <time_frame>after 30 minutes of admission</time_frame>
      <description>in ml equivalent per liter</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>urine output</measure>
      <time_frame>in 1 hour after admission</time_frame>
      <description>in ml/ hour</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>length of stay in ICU</measure>
      <time_frame>1 hour after discharge</time_frame>
      <description>in days</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>specificity of lung ultrasound predicting fluid responsiveness</measure>
      <time_frame>5 minutes after admission</time_frame>
      <description>&lt;0.8 non specific &gt; 0.8 specific</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>sensitivity of IVC ultrasound predicting fluid responsiveness</measure>
      <time_frame>after 5 minutes of admission</time_frame>
      <description>&lt;0.8 non sensitive &gt;0.8 sensitive</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>sensitivity of pulse pressure variation predicting fluid responsiveness</measure>
      <time_frame>after 5 minutes of admission</time_frame>
      <description>&lt;0.8 non sensitive &gt;0.8 sensitive</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>specificity of IVC ultrasound predicting fluid responsiveness</measure>
      <time_frame>after 5 minutes of admission</time_frame>
      <description>&lt;0.8 non sensitive &gt;0.8 sensitive</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>specificity of pulse pressure variation predicting fluid responsiveness</measure>
      <time_frame>after 5 minutes of admission</time_frame>
      <description>&lt;0.8 non sensitive &gt;0.8 sensitive</description>
    </secondary_outcome>
    <other_outcome>
      <measure>weight</measure>
      <time_frame>5 minutes before admission</time_frame>
      <description>in kilogram</description>
    </other_outcome>
    <other_outcome>
      <measure>height</measure>
      <time_frame>5 minutes before admission</time_frame>
      <description>in centimeters</description>
    </other_outcome>
    <other_outcome>
      <measure>body mass index</measure>
      <time_frame>5 minutes before admission</time_frame>
      <description>in kilogram/m2</description>
    </other_outcome>
    <other_outcome>
      <measure>age</measure>
      <time_frame>5 minutes before admission</time_frame>
      <description>in years</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Sepsis</condition>
    <condition>Critical Illness</condition>
    <arm_group>
      <arm_group_label>Scanning group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Lung ultrasound (LUS), Inferior vena cava ultrasound (IVC US) and pulse pressure variation (PPV) will be done to every patient in the study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>normal Saline</intervention_name>
      <description>normal saline cyrstalloids infusion with rate of 4ml/kg /h for 3 hours</description>
      <arm_group_label>Scanning group</arm_group_label>
      <other_name>Fluid challenge test</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>lung ultrasound</intervention_name>
      <description>Lung ultrasound by Philips clear vue350, Philips healthcare, Andover MAO1810, USA, Machine ID:1385 will scan For each hemi-thorax 3 main areas (anterior (Ant), lateral (Lt) and posterior (Post)) marked by the para-sternal, anterior axillary and posterior axillary lines for a total of 28 sectors will be identified</description>
      <arm_group_label>Scanning group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>inferior vena cava measurements</intervention_name>
      <description>The inferior vena cava was explored in the subxiphoid window in its sagittal view-just below the junction between the inferior vena cava and suprahepatic veins which lie approximately 0.5 to 3 cm from the right atrium, following the American Society of Echocardiography guidelines.; The (IVC distensibility index (dIVC) was calculated as (maximum diameter - minimum diameter)/minimum diameter.</description>
      <arm_group_label>Scanning group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>passive leg raising test (PLRT)</intervention_name>
      <description>Regardless of CVP (i.e., during &quot;blind PLR&quot;), noninvasiveΔPLR systolic arterial pressure (SAP) more than 17% reliably identify fluid responders. During &quot;CVP-guided PLR&quot;, in case of sufficient change in CVP (at least of 2 mmHg), noninvasiveΔPLR SAP perform better (cutoff of 9%). These findings, in sedated patients who had already undergone volume expansion and/or catecholamines, have to be verified during the early phase of circulatory failure (before an arterial line).</description>
      <arm_group_label>Scanning group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>pulse pressure variation</intervention_name>
      <description>patients will be temporarily sedated and paralyzed and on fully controlled mechanical ventilation. No spontaneous breathing effort will be detected on the mechanical ventilator waveform monitor ensuring that the respiratory changes in arterial pressure reflected only the effects of positive pressure ventilation. Modes of ventilation is selected to volume or pressure controlled ventilation, depending on the decision of the primary physicians. A tidal volume will be not less than 8 ml/ kg (predicted body weight). The preset respiratory rate will be at 14 breath/min. Positive end expiratory pressure (PEEP) will be between 8 and 10 cmH2O. The plateau pressure was kept at below 30 cmH2O. In all patients, radial artery cannulation will be done for invasive blood pressure monitoring (using a 20 G cannula), PPV is calculated directly on Nihon Kohden monitores at base line.</description>
      <arm_group_label>Scanning group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients on mechanical ventilation (MV).&#xD;
  &#xD;
            -  Aged more than 18 years.&#xD;
  &#xD;
            -  Mean arterial pressure (MAP) less than 65 mmHg or systolic arterial pressure less than&#xD;
               90mm Hg with signs of hypoperfusion (urinary flow &lt; 0.5mL/kg/ h for &gt; 2hr ,&#xD;
               tachycardia &gt; 100 beats/min, or presence of skin mottling , and seurm lactate more&#xD;
               than 2 mmol/L).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Cardiac arrhythmias.&#xD;
  &#xD;
            -  Previously known significant valvular disease or intracardiac shunt.&#xD;
  &#xD;
            -  Chest drains.&#xD;
  &#xD;
            -  Increasing intra abdominal pressure.&#xD;
  &#xD;
            -  Prephiral vascular disesaes.&#xD;
  &#xD;
            -  Adult respiratory distress syndrome (ARDS) patients due to low tidal volume.&#xD;
  &#xD;
            -  Interstitial lung disease because B-lines in these conditions are the consequence of&#xD;
               the thickened interlobular septa characterizing ﬁbrosis and are not modiﬁed by the&#xD;
               state of hydration or imbibition 12&#xD;
  &#xD;
            -  Any contraindication for fluid administration as cardiogenic shock, acute pulmonary&#xD;
               edema or LVEF% less than 50%.&#xD;
  &#xD;
            -  Renal patients with oliguria and volume overload including patients on hemodialysis or&#xD;
               patients with acute anuric renal failure.&#xD;
  &#xD;
            -  Patients with lower extremity artery/vein thrombosis, significant lower extremity&#xD;
               artery plaque, lower extremity artery occlusion, inferior vena cava filter&#xD;
               implantation and lower extremity varicose veins.&#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>omar S farghaly, MD</last_name>
      <role>Study Director</role>
      <affiliation>lecturer</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Joseph M Botros, MD</last_name>
      <phone>0122758825</phone>
      <phone_ext>002</phone_ext>
      <email>dr_jo27@yahoo.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>mohamed A hamed, MD</last_name>
      <phone>01010509736</phone>
      <phone_ext>002</phone_ext>
      <email>mah7@fayoum.edu.eg</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Fayoum University Hospital</name>
        <address>
          <city>Fayoum</city>
          <zip>63514</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>mohamed a hamed, MD</last_name>
        <phone>01010509736</phone>
        <phone_ext>002</phone_ext>
        <email>mah07@fayoum.edu.eg</email>
      </contact>
      <contact_backup>
        <last_name>Yasser S Mostafa, MD</last_name>
        <phone>01010509735</phone>
        <phone_ext>002</phone_ext>
        <email>ysm03@fayoum.edu.eg</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Chvojka J, Matejovic M. [International guidelines for management of severe sepsis and septic shock 2012 - comment]. Vnitr Lek. 2014 Jan;60(1):59-67. Czech.</citation>
      <PMID>24564777</PMID>
    </reference>
    <reference>
      <citation>Haddam M, Zieleskiewicz L, Perbet S, Baldovini A, Guervilly C, Arbelot C, Noel A, Vigne C, Hammad E, Antonini F, Lehingue S, Peytel E, Lu Q, Bouhemad B, Golmard JL, Langeron O, Martin C, Muller L, Rouby JJ, Constantin JM, Papazian L, Leone M; CAR'Echo Collaborative Network; AzuRea Collaborative Network. Lung ultrasonography for assessment of oxygenation response to prone position ventilation in ARDS. Intensive Care Med. 2016 Oct;42(10):1546-1556. doi: 10.1007/s00134-016-4411-7. Epub 2016 Jun 20.</citation>
      <PMID>27324241</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 19, 2023</last_update_submitted>
    <last_update_submitted_qc>August 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fayoum University Hospital</investigator_affiliation>
      <investigator_full_name>Mohamed Ahmed Hamed</investigator_full_name>
      <investigator_title>Associate professor</investigator_title>
    </responsible_party>
    <keyword>lung utlrasound</keyword>
    <keyword>pulse pressure variation</keyword>
    <keyword>inferior vena cava</keyword>
    <keyword>fluid responsiveness</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Critical Illness</mesh_term>
    </condition_browse>
    <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/NCT05980494
  org study id: D 310
  nct id: NCT05980494
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Evaluation and management of intravascular volume are a central challenge for the critical
        ill patients. Hypotensive patients are commonly resuscitated with intravenous crystalloid
        fluid as a recommendation for treatment of many shock states.
  
        There has been a growing interest in the implementation of lung ultrasound in critical care
        management in the last decade as it is easy, bedside, non-expensive, non invasive and
        radiation free.
  
        The object of the current study is to assess the ability of lung and inferior vena cava
        sonography versus pulse pressure variation to predict fluid responsiveness in patients with
        circulatory failure on mechanical ventilation.
  The study will be conducted in intensive care units of Fayoum University Hospitals after
        approval of the local institutional ethics committee and local institutional review board.
        Hypotensive Patients on mechanical ventilation starting from August 2022 will be enrolled in
        this prospective study until fulfilling sample size. A detailed informed consent will be
        signed before recruitment. All patients who fulfilled inclusion criteria will be monitored
        by: 6 leads ECG, Blood pressure, Urinary catheter for urine output, Pulse oximter.Lung
        ultrasound (LUS), Inferior vena cava ultrasound (IVC US) and pulse pressure variation (PPV)
        will be done to every patient in the study. The Consolidated standards of Reporting Trials
        (CONSORT) recommendation will be followed. LUS and IVC measurements were performed by using a
        convex ultrasound probe (Philips clear vue350, Philips healthcare, Andover MAO1810, USA,
        Machine ID: 1385). LUS will be performed by an experienced radiologist according to
        standardized protocols. For each hemi-thorax 3 main areas (anterior (Ant), lateral (Lt) and
        posterior (Post)) marked by the para-sternal, anterior axillary and posterior axillary lines
        for a total of 28 sectors will be identified. Each one will be divided into upper and lower
        halves, making a sum of 6 different quadrants for each side: anterior superior, anterior
        inferior, lateral superior, lateral inferior, posterior superior, posterior inferior.
        Ultrasound examination of the anterolateral chest was carried out with longitudinal scan of
        the right and left hemi thoraces, from the second to the fourth (on the right side to the
        ﬁfth) intercostal space, as previously described. For each quadrant a score will be assigned
        based on B lines which are defined as an echogenic artifact with a narrow origin on the
        pleural line, deepening to the inferior border of the screen and coherent with respiratory
        movements indicating subpleural interstitial edema as follows:
  
        (0) Normal aeration: A lines with lung sliding or fewer than two isolated B lines
  
          1. Moderate loss of lung aeration: well-defined, multiple B lines.
  
          2. Severe loss of lung aeration: multiple coalescent B lines.
  
          3. Complete loss of lung aeration or lung consolidation. This will be used to calculate
             total LUS-score (calculated as a sum of all quadrants score) and individual areas score
             (Ant, Lt and Post).
  
        IVC US: The inferior vena cava was explored in the subxiphoid window in its sagittal
        view-just below the junction between the inferior vena cava and suprahepatic veins which lie
        approximately 0.5 to 3 cm from the right atrium, following the American Society of
        Echocardiography guidelines.; The (IVC distensibility index (dIVC) was calculated as (maximum
        diameter - minimum diameter)/minimum diameter.
  
        PPV: patients will be temporarily sedated and paralyzed and on fully controlled mechanical
        ventilation. No spontaneous breathing effort will be detected on the mechanical ventilator
        waveform monitor ensuring that the respiratory changes in arterial pressure reflected only
        the effects of positive pressure ventilation. Modes of ventilation is selected to volume or
        pressure controlled ventilation, depending on the decision of the primary physicians. A tidal
        volume will be not less than 8 ml/ kg (predicted body weight). The preset respiratory rate
        will be at 14 breath/min. Positive end expiratory pressure (PEEP) will be between 8 and 10
        cmH2O. The plateau pressure was kept at below 30 cmH2O. In all patients, radial artery
        cannulation will be done for invasive blood pressure monitoring (using a 20 G cannula), PPV
        is calculated directly on Nihon Kohden monitores at base line.
  
        • Sample size: Sample size was calculated using MedCalc Statistical Software version 20
        (MedCalc Software, Ostend, Belgium. Minimal sample size of patients was 118 patients with 59
        responsive cases and 59 non-responsive cases. Calculation is guided by AUC of 0.915 obtained
        from a study in comparison to a null value of 0.8, with alpha of 0.05 and power of 90%.
        Sample size will be increased to 150 patients to increase precision and ensure that at least
        59 responsive and 59 non-responsive cases are included.
  
        • Statistical analysis: Data will be collected and coded using Microsoft Excel and data
        analysis will be performed using IBM SPSS version 28 for Windows. Descriptive statistics will
        be presented in the form of numbers and percentages of categorical data, while means with
        standard deviations or medians with interquartile ranges will be used for numerical data
        variables. ROC curve will be used to estimate the appropriate cut off point for the inferior
        vena cava distensibility index, and for the lung ultrasound score. Area under the curve (AUC)
        will be reported and will be used to compare the diagnostic ability of different tests.
        Sensitivity, specificity, positive predictive value and negative predictive value will be
        reported with the 95% confidence intervals. P-value < 0.05 will be considered statistically
        significant.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: The sensitivity of lung ultrasound in predicting fluid responsiveness.
  time frame: After 5 minutes of admission
  description: <0.8: non-sensitive, >0.8: sensitive
  measure: lung ultrasound B lines score
  time frame: after 5 minutes of admission
  description: (0) Normal aeration: A lines with lung sliding or fewer than two isolated B lines
  Moderate loss of lung aeration: well-defined, multiple B lines.
  Severe loss of lung aeration: multiple coalescent B lines.
  Complete loss of lung aeration or lung consolidation. This will be used to calculate total LUS-score (calculated as a sum of all quadrants score) and individual areas score (Ant, Lt and Post).
  measure: Inferior vena cava distensibility index.
  time frame: after 10 minutes of admission
  description: (maximum diameter - minimum diameter)/minimum diameter.
  measure: pulse pressure variation
  time frame: 15 minutes after admission
  description: in percent
  measure: central venous pressure
  time frame: after 20 minutes of admission
  description: in centimeter water
  measure: heart rate
  time frame: 5 minutes after admission
  description: in beat per minute
  measure: serum lactate
  time frame: after 30 minutes of admission
  description: in ml equivalent per liter
  measure: urine output
  time frame: in 1 hour after admission
  description: in ml/ hour
  measure: length of stay in ICU
  time frame: 1 hour after discharge
  description: in days
  measure: specificity of lung ultrasound predicting fluid responsiveness
  time frame: 5 minutes after admission
  description: <0.8 non specific > 0.8 specific
  measure: sensitivity of IVC ultrasound predicting fluid responsiveness
  time frame: after 5 minutes of admission
  description: <0.8 non sensitive >0.8 sensitive
  measure: sensitivity of pulse pressure variation predicting fluid responsiveness
  time frame: after 5 minutes of admission
  description: <0.8 non sensitive >0.8 sensitive
  measure: specificity of IVC ultrasound predicting fluid responsiveness
  time frame: after 5 minutes of admission
  description: <0.8 non sensitive >0.8 sensitive
  measure: specificity of pulse pressure variation predicting fluid responsiveness
  time frame: after 5 minutes of admission
  description: <0.8 non sensitive >0.8 sensitive
  measure: weight
  time frame: 5 minutes before admission
  description: in kilogram
  measure: height
  time frame: 5 minutes before admission
  description: in centimeters
  measure: body mass index
  time frame: 5 minutes before admission
  description: in kilogram/m2
  measure: age
  time frame: 5 minutes before admission
  description: in years
  arm group label: Scanning group
  arm group type: Experimental
  description: Lung ultrasound (LUS), Inferior vena cava ultrasound (IVC US) and pulse pressure variation (PPV) will be done to every patient in the study.
  intervention type: Drug
  intervention name: normal Saline
  description: normal saline cyrstalloids infusion with rate of 4ml/kg /h for 3 hours
  arm group label: Scanning group
  other name: Fluid challenge test
  intervention type: Device
  intervention name: lung ultrasound
  description: Lung ultrasound by Philips clear vue350, Philips healthcare, Andover MAO1810, USA, Machine ID:1385 will scan For each hemi-thorax 3 main areas (anterior (Ant), lateral (Lt) and posterior (Post)) marked by the para-sternal, anterior axillary and posterior axillary lines for a total of 28 sectors will be identified
  arm group label: Scanning group
  intervention type: Device
  intervention name: inferior vena cava measurements
  description: The inferior vena cava was explored in the subxiphoid window in its sagittal view-just below the junction between the inferior vena cava and suprahepatic veins which lie approximately 0.5 to 3 cm from the right atrium, following the American Society of Echocardiography guidelines.; The (IVC distensibility index (dIVC) was calculated as (maximum diameter - minimum diameter)/minimum diameter.
  arm group label: Scanning group
  intervention type: Diagnostic Test
  intervention name: passive leg raising test (PLRT)
  description: Regardless of CVP (i.e., during "blind PLR"), noninvasiveΔPLR systolic arterial pressure (SAP) more than 17% reliably identify fluid responders. During "CVP-guided PLR", in case of sufficient change in CVP (at least of 2 mmHg), noninvasiveΔPLR SAP perform better (cutoff of 9%). These findings, in sedated patients who had already undergone volume expansion and/or catecholamines, have to be verified during the early phase of circulatory failure (before an arterial line).
  arm group label: Scanning group
  intervention type: Device
  intervention name: pulse pressure variation
  description: patients will be temporarily sedated and paralyzed and on fully controlled mechanical ventilation. No spontaneous breathing effort will be detected on the mechanical ventilator waveform monitor ensuring that the respiratory changes in arterial pressure reflected only the effects of positive pressure ventilation. Modes of ventilation is selected to volume or pressure controlled ventilation, depending on the decision of the primary physicians. A tidal volume will be not less than 8 ml/ kg (predicted body weight). The preset respiratory rate will be at 14 breath/min. Positive end expiratory pressure (PEEP) will be between 8 and 10 cmH2O. The plateau pressure was kept at below 30 cmH2O. In all patients, radial artery cannulation will be done for invasive blood pressure monitoring (using a 20 G cannula), PPV is calculated directly on Nihon Kohden monitores at base line.
  arm group label: Scanning group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: omar S farghaly, MD
  role: Study Director
  affiliation: lecturer
  last name: Joseph M Botros, MD
  phone: 0122758825
  phone ext: 002
  email: dr_jo27@yahoo.com
  last name: mohamed A hamed, MD
  phone: 01010509736
  phone ext: 002
  email: mah7@fayoum.edu.eg
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Egypt
  citation: Chvojka J, Matejovic M. [International guidelines for management of severe sepsis and septic shock 2012 - comment]. Vnitr Lek. 2014 Jan;60(1):59-67. Czech.
  PMID: 24564777
  citation: Haddam M, Zieleskiewicz L, Perbet S, Baldovini A, Guervilly C, Arbelot C, Noel A, Vigne C, Hammad E, Antonini F, Lehingue S, Peytel E, Lu Q, Bouhemad B, Golmard JL, Langeron O, Martin C, Muller L, Rouby JJ, Constantin JM, Papazian L, Leone M; CAR'Echo Collaborative Network; AzuRea Collaborative Network. Lung ultrasonography for assessment of oxygenation response to prone position ventilation in ARDS. Intensive Care Med. 2016 Oct;42(10):1546-1556. doi: 10.1007/s00134-016-4411-7. Epub 2016 Jun 20.
  PMID: 27324241
  responsible party type: Principal Investigator
  investigator affiliation: Fayoum University Hospital
  investigator full name: Mohamed Ahmed Hamed
  investigator title: Associate professor
  mesh term: Critical Illness
  sharing ipd: No