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/NCT05968040</url>
    </required_header>
    <id_info>
      <org_study_id>ain shams H.</org_study_id>
      <nct_id>NCT05968040</nct_id>
    </id_info>
    <brief_title>Point Of Care Ultrasound For Prediction Of Fluid Responsiveness in Off Pump Coronary Artery Bypass Grafting Surgery</brief_title>
    <official_title>Point Of Care Ultrasound For Prediction Of Fluid Responsiveness in Off Pump Coronary Artery Bypass Grafting Surgery, Comparison Between Carotid Doppler Peak Velocity And IVC Distensibility Index</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ain Shams University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ain Shams University</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>
        To exclude hypovolemia before starting off pump coronary artery grafting surgeries by an&#xD;
        efficient and good predictive test. We will assess the sensitivity and specificity of dynamic&#xD;
        IVC-derived parameters (dispensability index) in comparison to carotid Doppler peak velocity&#xD;
        as predictors of fluid response before skin incision in patients undergoing off Pump cardiac&#xD;
        surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Monitoring We will monitor all patients using, invasive blood pressure, pulse oximeter,&#xD;
        central venous pressure (CVP), 5 leads Electrocardiogram ECG and capnogram.&#xD;
  &#xD;
        Anesthetic technique:&#xD;
  &#xD;
        Anesthesia will be inducted by; lidocaine 1.5 mg/Kg, fentanyl 10 mic/kg, propofol (2 mg/kg)&#xD;
        and atracurium (0.5 mg/kg). After good muscle relaxation, intubation will be done smoothly.&#xD;
        Mechanical ventilation parameters will be fixed in all patients during the study period.&#xD;
        Tidal volume will be adjusted to 10 ml/kg without positive end expiration pressure. End tidal&#xD;
        carbon dioxide will be kept around 35-40 centimeter water(cmH2O). Anesthesia will be&#xD;
        maintained by Sevoflurane 2% minimal alveolar concentration(MAC), atracurium infusion;&#xD;
        0.05-0.01 mg/kg/min and fentanyl infusion rate; 1 mic/kg/hour.&#xD;
  &#xD;
        Study measurements:&#xD;
  &#xD;
        After induction of anesthesia we will perform the measurement of the diameter of the inferior&#xD;
        vena cava through standard ultrasonic techniques. The M-mode portable ultrasound 1-5&#xD;
        megahertz (MHz) transthoracic phased-array transducer probe will be positioned longitudinally&#xD;
        along the xiphoid process when the patient is supine. The diameter of the inferior vena cava&#xD;
        will be measured at 2 cm close to the entrance of the right atrium. Ultrasound images will be&#xD;
        taken at the end of inspiration (Dmax) and at the end expiration (Dmin) to calculate the&#xD;
        inferior vena cava dispensability index (dIVC), and will be recorded before and after fluid&#xD;
        challenge test of 5 ml/kg crystalloid within 15 min. The inferior vena cava (IVC)&#xD;
        distensibility index (IVC-DI) will be calculated using the formula: IVC-DI = IVCmax - IVCmin/&#xD;
        IVCmin. The indices will be expressed as a percentage.&#xD;
  &#xD;
        Carotid ultrasound images will be obtained from the left common carotid artery( CCA) in both&#xD;
        short-axis and long-axis views by experienced sonographers. The patient will be in supine&#xD;
        position, with the head rotated slightly to the right. A broadband linear array transducer&#xD;
        12-4 MHz and the short-axis view will be used for orientation and identification of the CCA.&#xD;
        Next, in the long-axis view, Peak Waveform Doppler signals will be acquired by placing a 0.5&#xD;
        mm calliper at the center of the vessel and parallel to the vessel walls, approximately 2 cm&#xD;
        proximal from the carotid bifurcation. Insonation-angles between the ultrasound beam and&#xD;
        blood flow will be maintained.&#xD;
  &#xD;
        difference of peak velocity(ΔVpeak) of CCA = (MaxCDPV-MinCDPV)+(MaxCDPV+MinCDPV)x100 2&#xD;
  &#xD;
        cardiac output (CO) will be recorded as baseline measure and after fluid administration. If&#xD;
        CO increased more than 15%, it will be considered fluid responder. Increase in cardiac output&#xD;
        = (cardiac output after first fluid challenge - cardiac output before)/cardiac output before)&#xD;
        X 100.&#xD;
  &#xD;
        Transthoracic echocardiography(TTE) will be used to measure LTOT and velocity time integral&#xD;
        (VTI) x heart rate (HR).&#xD;
  &#xD;
        CVP, mean arterial pressure, pulse pressure, difference between diameters of IVC during&#xD;
        inspiration and expiration (ΔIVC-d) in single respiratory cycle, and difference between&#xD;
        velocities of carotid Doppler peak velocity in single respiratory cycle (ΔCDPV) will all be&#xD;
        measured as hemodynamic records.&#xD;
  &#xD;
        The benefits include declining heart rate, normotension, and increase and urine volume, also&#xD;
        known as fluid responsiveness&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>cardiac output by transthoracic echocardiography</measure>
      <time_frame>immediately before fluid administration</time_frame>
      <description>cardiac output = stroke volume x heart rate</description>
    </primary_outcome>
    <primary_outcome>
      <measure>cardiac outputby transthoracic echocardiography</measure>
      <time_frame>immediately after fluid administration</time_frame>
      <description>cardiac output = stroke volume x heart rate</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>inferior vena cava diameter by ultrasonography</measure>
      <time_frame>immediately before fluid administration</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>inferior vena cava diameter by ultrasonography</measure>
      <time_frame>immediately after fluid administration</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>carotid peak velocity by ultrasound</measure>
      <time_frame>immediately before fluid administration</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>carotid peak velocity by ultrasound</measure>
      <time_frame>immediately after fluid administration</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>central venous pressure measurement</measure>
      <time_frame>immediately before fluid administration</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>central venous pressure measurement</measure>
      <time_frame>immediately after fluid administration</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>mean blood pressure</measure>
      <time_frame>immediately before fluid administration</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>mean blood pressure</measure>
      <time_frame>immediately after fluid administration</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>heart rate</measure>
      <time_frame>immediately before fluid administration</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>heart rate</measure>
      <time_frame>immediately after fluid administration</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>usage of ionotropic support (adrenalin, noreadrenalin,dopamine and dubotamine)</measure>
      <time_frame>during the intraoperative period</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Prevention of Hypotension</condition>
    <arm_group>
      <arm_group_label>responder</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>non responder</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Inferior vena cava diameter measurement by ultrasonography</intervention_name>
      <description>The diameter of the inferior vena cava will be measured at 2 cm close to the entrance of the right atrium. Ultrasound images will be taken at the end of inspiration (Dmax) and at the end expiration (Dmin) to calculate the inferior vena cava dispensability index (dIVC), and will be recorded before and after fluid challenge test of 5 ml/kg crystalloid within 15 min. The IVC distensibility index (IVC-DI) will be calculated using the formula: IVC-DI = IVCmax - IVCmin/ IVCmin. The indices will be expressed as a percentage.</description>
      <arm_group_label>non responder</arm_group_label>
      <arm_group_label>responder</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>difference between peak velocities of carotid artery by ultrasound</intervention_name>
      <description>Carotid ultrasound images will be obtained from the left CCA in both short-axis and long-axis views by experienced sonographers. The patient will be in supine position, with the head rotated slightly to the right. A broadband linear array transducer 12-4 MHz and the short-axis view will be used for orientation and identification of the CCA. Next, in the long-axis view, Peak Waveform Doppler signals will be acquired by placing a 0.5 mm calliper at the center of the vessel and parallel to the vessel walls, approximately 2 cm proximal from the carotid bifurcation. Insonation-angles between the ultrasound beam and blood flow will be maintained.&#xD;
  ΔVpeakCCA = (MaxCDPV-MinCDPV)+(MaxCDPV+MinCDPV)x100</description>
      <arm_group_label>non responder</arm_group_label>
      <arm_group_label>responder</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>cardiac output be transthoracic echocardiography</intervention_name>
      <description>CO will be recorded as baseline measure and after fluid administration. If CO increased more than 15%, it will be considered fluid responder. Increase in cardiac output = (cardiac output after first fluid challenge - cardiac output before)/cardiac output before) X 100.&#xD;
  TTE will be used to measure LTOT and VTI x HR.</description>
      <arm_group_label>non responder</arm_group_label>
      <arm_group_label>responder</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with accepted cardiac capacity (EF &gt;45%)&#xD;
  &#xD;
            -  Patients scheduled for off pump open heart surgeries for coronary artery grafting&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  age under 18 years,&#xD;
  &#xD;
            -  patients with poor cardiac capacity&#xD;
  &#xD;
            -  patients suffering any type of arrhythmias&#xD;
  &#xD;
            -  preoperative left ventricular dilatation (end-diastolic dimension ≥6 cm)&#xD;
  &#xD;
            -  preoperative severe tricuspid valve regurgitation,&#xD;
  &#xD;
            -  preoperative right ventricular dysfunction&#xD;
  &#xD;
            -  patients with high intrathoracic pressure e.g.chronic obstructive pulmonary disease&#xD;
               (COPD).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 16, 2023</study_first_submitted>
    <study_first_submitted_qc>July 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 22, 2023</last_update_submitted>
    <last_update_submitted_qc>July 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ain Shams University</investigator_affiliation>
      <investigator_full_name>RAMY AHMED</investigator_full_name>
      <investigator_title>Assistant Professor of Anesthesia</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypotension</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/NCT05968040
  org study id: ain shams H.
  nct id: NCT05968040
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To exclude hypovolemia before starting off pump coronary artery grafting surgeries by an
        efficient and good predictive test. We will assess the sensitivity and specificity of dynamic
        IVC-derived parameters (dispensability index) in comparison to carotid Doppler peak velocity
        as predictors of fluid response before skin incision in patients undergoing off Pump cardiac
        surgery.
  Monitoring We will monitor all patients using, invasive blood pressure, pulse oximeter,
        central venous pressure (CVP), 5 leads Electrocardiogram ECG and capnogram.
  
        Anesthetic technique:
  
        Anesthesia will be inducted by; lidocaine 1.5 mg/Kg, fentanyl 10 mic/kg, propofol (2 mg/kg)
        and atracurium (0.5 mg/kg). After good muscle relaxation, intubation will be done smoothly.
        Mechanical ventilation parameters will be fixed in all patients during the study period.
        Tidal volume will be adjusted to 10 ml/kg without positive end expiration pressure. End tidal
        carbon dioxide will be kept around 35-40 centimeter water(cmH2O). Anesthesia will be
        maintained by Sevoflurane 2% minimal alveolar concentration(MAC), atracurium infusion;
        0.05-0.01 mg/kg/min and fentanyl infusion rate; 1 mic/kg/hour.
  
        Study measurements:
  
        After induction of anesthesia we will perform the measurement of the diameter of the inferior
        vena cava through standard ultrasonic techniques. The M-mode portable ultrasound 1-5
        megahertz (MHz) transthoracic phased-array transducer probe will be positioned longitudinally
        along the xiphoid process when the patient is supine. The diameter of the inferior vena cava
        will be measured at 2 cm close to the entrance of the right atrium. Ultrasound images will be
        taken at the end of inspiration (Dmax) and at the end expiration (Dmin) to calculate the
        inferior vena cava dispensability index (dIVC), and will be recorded before and after fluid
        challenge test of 5 ml/kg crystalloid within 15 min. The inferior vena cava (IVC)
        distensibility index (IVC-DI) will be calculated using the formula: IVC-DI = IVCmax - IVCmin/
        IVCmin. The indices will be expressed as a percentage.
  
        Carotid ultrasound images will be obtained from the left common carotid artery( CCA) in both
        short-axis and long-axis views by experienced sonographers. The patient will be in supine
        position, with the head rotated slightly to the right. A broadband linear array transducer
        12-4 MHz and the short-axis view will be used for orientation and identification of the CCA.
        Next, in the long-axis view, Peak Waveform Doppler signals will be acquired by placing a 0.5
        mm calliper at the center of the vessel and parallel to the vessel walls, approximately 2 cm
        proximal from the carotid bifurcation. Insonation-angles between the ultrasound beam and
        blood flow will be maintained.
  
        difference of peak velocity(ΔVpeak) of CCA = (MaxCDPV-MinCDPV)+(MaxCDPV+MinCDPV)x100 2
  
        cardiac output (CO) will be recorded as baseline measure and after fluid administration. If
        CO increased more than 15%, it will be considered fluid responder. Increase in cardiac output
        = (cardiac output after first fluid challenge - cardiac output before)/cardiac output before)
        X 100.
  
        Transthoracic echocardiography(TTE) will be used to measure LTOT and velocity time integral
        (VTI) x heart rate (HR).
  
        CVP, mean arterial pressure, pulse pressure, difference between diameters of IVC during
        inspiration and expiration (ΔIVC-d) in single respiratory cycle, and difference between
        velocities of carotid Doppler peak velocity in single respiratory cycle (ΔCDPV) will all be
        measured as hemodynamic records.
  
        The benefits include declining heart rate, normotension, and increase and urine volume, also
        known as fluid responsiveness
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: cardiac output by transthoracic echocardiography
  time frame: immediately before fluid administration
  description: cardiac output = stroke volume x heart rate
  measure: cardiac outputby transthoracic echocardiography
  time frame: immediately after fluid administration
  description: cardiac output = stroke volume x heart rate
  measure: inferior vena cava diameter by ultrasonography
  time frame: immediately before fluid administration
  measure: inferior vena cava diameter by ultrasonography
  time frame: immediately after fluid administration
  measure: carotid peak velocity by ultrasound
  time frame: immediately before fluid administration
  measure: carotid peak velocity by ultrasound
  time frame: immediately after fluid administration
  measure: central venous pressure measurement
  time frame: immediately before fluid administration
  measure: central venous pressure measurement
  time frame: immediately after fluid administration
  measure: mean blood pressure
  time frame: immediately before fluid administration
  measure: mean blood pressure
  time frame: immediately after fluid administration
  measure: heart rate
  time frame: immediately before fluid administration
  measure: heart rate
  time frame: immediately after fluid administration
  measure: usage of ionotropic support (adrenalin, noreadrenalin,dopamine and dubotamine)
  time frame: during the intraoperative period
  arm group label: responder
  arm group type: Active Comparator
  arm group label: non responder
  arm group type: Active Comparator
  intervention type: Procedure
  intervention name: Inferior vena cava diameter measurement by ultrasonography
  description: The diameter of the inferior vena cava will be measured at 2 cm close to the entrance of the right atrium. Ultrasound images will be taken at the end of inspiration (Dmax) and at the end expiration (Dmin) to calculate the inferior vena cava dispensability index (dIVC), and will be recorded before and after fluid challenge test of 5 ml/kg crystalloid within 15 min. The IVC distensibility index (IVC-DI) will be calculated using the formula: IVC-DI = IVCmax - IVCmin/ IVCmin. The indices will be expressed as a percentage.
  arm group label: non responder
  arm group label: responder
  intervention type: Procedure
  intervention name: difference between peak velocities of carotid artery by ultrasound
  description: Carotid ultrasound images will be obtained from the left CCA in both short-axis and long-axis views by experienced sonographers. The patient will be in supine position, with the head rotated slightly to the right. A broadband linear array transducer 12-4 MHz and the short-axis view will be used for orientation and identification of the CCA. Next, in the long-axis view, Peak Waveform Doppler signals will be acquired by placing a 0.5 mm calliper at the center of the vessel and parallel to the vessel walls, approximately 2 cm proximal from the carotid bifurcation. Insonation-angles between the ultrasound beam and blood flow will be maintained.
  ΔVpeakCCA = (MaxCDPV-MinCDPV)+(MaxCDPV+MinCDPV)x100
  arm group label: non responder
  arm group label: responder
  intervention type: Procedure
  intervention name: cardiac output be transthoracic echocardiography
  description: CO will be recorded as baseline measure and after fluid administration. If CO increased more than 15%, it will be considered fluid responder. Increase in cardiac output = (cardiac output after first fluid challenge - cardiac output before)/cardiac output before) X 100.
  TTE will be used to measure LTOT and VTI x HR.
  arm group label: non responder
  arm group label: responder
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Ain Shams University
  investigator full name: RAMY AHMED
  investigator title: Assistant Professor of Anesthesia
  mesh term: Hypotension
  sharing ipd: No