<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/NCT03815188</url>
  </required_header>
  <id_info>
    <org_study_id>STH20529</org_study_id>
    <nct_id>NCT03815188</nct_id>
  </id_info>
  <brief_title>Use of the SonoSite Probe for Measuring Jugular Venous Pressure</brief_title>
  <acronym>PRAGUE</acronym>
  <official_title>Use of the SonoSite Probe for Measuring Jugular Venous Pressure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheffield Teaching Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Sheffield</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sheffield Teaching Hospitals NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</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>
      This prospective study will be performed in the Cardiothoracic (Chesterman) Department at&#xD;
      Sheffield Teaching Hospitals NHSFT, Northern General Hospital. Pre-operative patients&#xD;
      undergoing surgical valvular intervention, breathing both spontaneously and mechanically will&#xD;
      be included in the trial. All patients will already have a central venous catheter inserted&#xD;
      as part of their ongoing care. Patients will be eligible for the study irrespective of&#xD;
      diagnosis or neck size. Patient demographical data will be recorded by Sam Jenkins following&#xD;
      written consent, the day before the trial.&#xD;
&#xD;
      The goal of this study is to determine if ultrasound assessment of Jugular Venous Pressure&#xD;
      (JVP) accurately predicts Central Venous Pressure (CVP). Secondary objectives aim to identify&#xD;
      if using the angle of Louis to approximate the location of the right atrium produces&#xD;
      inaccuracies when measuring JVP. Comparing results in patients breathing spontaneously or&#xD;
      under positive pressure ventilation will identify if the form of ventilation impacts on JVP&#xD;
      and CVP recording. Correlating results between physical JVP examination and ultrasound&#xD;
      assessment of JVP to measure CVP will conclude if ultrasound is a more appropriate tool, in&#xD;
      an era where the physical examination of the cardiovascular system is becoming less valuable.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Initial exploratory investigations will compare left-sided and right-sided Jugular Venous&#xD;
      Pressure (JVP) using ultrasonography. Should results show that they are the same, the central&#xD;
      line is to be placed into the right internal jugular vein when required.&#xD;
&#xD;
      To begin the trial and whilst the patient is spontaneously breathing, a physical examination&#xD;
      of the right JVP will be performed. A central line will be inserted with the patient awake&#xD;
      into the right internal jugular vein. Left-sided ultrasound of JVP and Central Venous&#xD;
      Pressure (CVP) will be measured using the right-sided catheter will be recorded&#xD;
      simultaneously. The tip of the catheter attached to the transducer (which is zeroed to the&#xD;
      reference point) will be placed at the point of venous collapse, identified by&#xD;
      ultrasonography, to identify if the JVP and CVP match. The tip of the catheter will then be&#xD;
      placed at the angle of Louis. Measurement of the pressure difference between the angle of&#xD;
      Louis and the reference point will identify if this value shows variability compared to&#xD;
      previous approximations of 5cm above the right atrium. With the patient anaesthetised and&#xD;
      mechanically breathing, left JVP and CVP will be measured once more. Twenty-four hours&#xD;
      post-surgery, ultrasound of the JVP and CVP will be measured with the patient breathing&#xD;
      spontaneously.&#xD;
&#xD;
      The physical JVP examination will be recorded from the opposite side to the central venous&#xD;
      catheter. The bed will be adjusted to an angle between 30 and 60 degrees, that most clearly&#xD;
      identifies the collapsing vein. Differentiation between the JVP and the carotid pulse must be&#xD;
      distinguished. Tangential lighting using a flashlight should be used to correctly identify&#xD;
      and note the apex of the jugular venous pulsations. Recordings will be taken at&#xD;
      end-expiration allowing the vertical distance between the venous meniscus and phlebostatic&#xD;
      axis to be measured. JVP will be measured in millimetres of water.&#xD;
&#xD;
      Ultrasound recordings will be made using the SonoSite ultrasound probe by Sam Jenkins. The&#xD;
      equipment and gels required are used routinely on site and will be supplied by Sheffield&#xD;
      Teaching Hospitals. The SonoSite probe will be calibrated prior to each use, based on the&#xD;
      recommendations of the manufacturer. The angle of the bed is kept constant and the patient&#xD;
      will remain in the same position following the physical JVP examination. Ultrasound gel will&#xD;
      be applied, again on the opposite side to the central venous catheter. Locating the area of&#xD;
      venous collapse will be identified following visualisation from both longitudinal and&#xD;
      transverse planes. The apex of venous collapse at end-expiration will be marked using the&#xD;
      longitudinal view. Corroboration of the correct position of the probe by looking at the&#xD;
      transverse view will be performed prior to marking of venous collapse.&#xD;
&#xD;
      CVP will be measured once the central venous catheter has been zeroed. The reference point of&#xD;
      the transducer will be placed at the 4th intercostal space, mid-axillary line. The bed should&#xD;
      still be kept at a constant angle for this measurement. The mean of the 'a' wave upon&#xD;
      end-expiration will be taken. Converting the CVP from millimetres of mercury to millimetres&#xD;
      of water will allow direct comparison to prior findings of JVP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2019</start_date>
  <completion_date type="Actual">August 31, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Ultrasonography</measure>
    <time_frame>Through study completion - 30/09/2019</time_frame>
    <description>Ultrasonography is expected to be a more accurate measure of CVP compared to physical JVP examination and is hypothesised to accurately predict CVP.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">124</enrollment>
  <condition>Aortic Valve Surgery</condition>
  <arm_group>
    <arm_group_label>Heart Valve Surgery</arm_group_label>
    <description>Pre-operative patients undergoing heart valve surgery will be selected and data recorded from each patient on the day of their surgery. This patient cohort is required in order to be able to accurately measure their JVP upon physical examination. Patients must have a central line inserted as part of their ongoing clinical management.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Pre-operative patients undergoing heart valve surgery will be selected and data recorded&#xD;
        from each patient on the day of their surgery. This patient cohort is required in order to&#xD;
        be able to accurately measure their JVP upon physical examination. Patients must have a&#xD;
        central line inserted as part of their ongoing clinical management. Patients will be&#xD;
        selected based on the weekly surgery schedule and will require participation of the&#xD;
        anaesthetist. The anaesthetist will be required to insert the central line, anaesthetise&#xD;
        the patient and adjust the transducer when asked.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing cardiac surgery&#xD;
&#xD;
          -  Patients who have a central line inserted during surgery&#xD;
&#xD;
          -  Patients able and willing to give consent in verbal and written English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under the age of 18&#xD;
&#xD;
          -  Patients unable to provide consent in verbal and written English&#xD;
&#xD;
          -  Patients with thyroid enlargement or alternative reason causing obstruction to venous&#xD;
             anatomy&#xD;
&#xD;
          -  Patients with significant tricuspid regurgitation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sheffield Teaching Hospitals NHS FT</name>
      <address>
        <city>Sheffield</city>
        <state>England</state>
        <zip>S10 2JF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Brennan JM, Blair JE, Goonewardena S, Ronan A, Shah D, Vasaiwala S, Brooks E, Levy A, Kirkpatrick JN, Spencer KT. A comparison by medicine residents of physical examination versus hand-carried ultrasound for estimation of right atrial pressure. Am J Cardiol. 2007 Jun 1;99(11):1614-6. doi: 10.1016/j.amjcard.2007.01.037. Epub 2007 Apr 18.</citation>
    <PMID>17531592</PMID>
  </reference>
  <reference>
    <citation>Cook DJ, Simel DL. The Rational Clinical Examination. Does this patient have abnormal central venous pressure? JAMA. 1996 Feb 28;275(8):630-4. No abstract available.</citation>
    <PMID>8594245</PMID>
  </reference>
  <reference>
    <citation>Deol GR, Collett N, Ashby A, Schmidt GA. Ultrasound accurately reflects the jugular venous examination but underestimates central venous pressure. Chest. 2011 Jan;139(1):95-100. doi: 10.1378/chest.10-1301. Epub 2010 Aug 26.</citation>
    <PMID>20798190</PMID>
  </reference>
  <reference>
    <citation>Fletcher RH, Fletcher SW. Has medicine outgrown physical diagnosis? Ann Intern Med. 1992 Nov 1;117(9):786-7. doi: 10.7326/0003-4819-117-9-786. No abstract available.</citation>
    <PMID>1416582</PMID>
  </reference>
  <reference>
    <citation>Jang T, Aubin C, Naunheim R, Char D. Ultrasonography of the internal jugular vein in patients with dyspnea without jugular venous distention on physical examination. Ann Emerg Med. 2004 Aug;44(2):160-8. doi: 10.1016/j.annemergmed.2004.03.014.</citation>
    <PMID>15278091</PMID>
  </reference>
  <reference>
    <citation>Lipton B. Estimation of central venous pressure by ultrasound of the internal jugular vein. Am J Emerg Med. 2000 Jul;18(4):432-4. doi: 10.1053/ajem.2000.7335.</citation>
    <PMID>10919533</PMID>
  </reference>
  <reference>
    <citation>Mangione S, Nieman LZ. Cardiac auscultatory skills of internal medicine and family practice trainees. A comparison of diagnostic proficiency. JAMA. 1997 Sep 3;278(9):717-22. Erratum In: JAMA 1998 May 13;279(18):1444.</citation>
    <PMID>9286830</PMID>
  </reference>
  <reference>
    <citation>Seth R, Magner P, Matzinger F, van Walraven C. How far is the sternal angle from the mid-right atrium? J Gen Intern Med. 2002 Nov;17(11):852-6. doi: 10.1046/j.1525-1497.2002.20101.x.</citation>
    <PMID>12406357</PMID>
  </reference>
  <reference>
    <citation>Socransky SJ, Wiss R, Robins R, Anawati A, Roy MA, Yeung IC. Defining normal jugular venous pressure with ultrasonography. CJEM. 2010 Jul;12(4):320-4. doi: 10.1017/s1481803500012409.</citation>
    <PMID>20650024</PMID>
  </reference>
  <reference>
    <citation>Sondergaard S, Parkin G, Aneman A. Central venous pressure: we need to bring clinical use into physiological context. Acta Anaesthesiol Scand. 2015 May;59(5):552-60. doi: 10.1111/aas.12490. Epub 2015 Feb 13.</citation>
    <PMID>25684176</PMID>
  </reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>January 21, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>October 30, 2019</last_update_submitted>
  <last_update_submitted_qc>October 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT03815188
org study id: STH20529
nct id: NCT03815188
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This prospective study will be performed in the Cardiothoracic (Chesterman) Department at
      Sheffield Teaching Hospitals NHSFT, Northern General Hospital. Pre-operative patients
      undergoing surgical valvular intervention, breathing both spontaneously and mechanically will
      be included in the trial. All patients will already have a central venous catheter inserted
      as part of their ongoing care. Patients will be eligible for the study irrespective of
      diagnosis or neck size. Patient demographical data will be recorded by Sam Jenkins following
      written consent, the day before the trial.

      The goal of this study is to determine if ultrasound assessment of Jugular Venous Pressure
      (JVP) accurately predicts Central Venous Pressure (CVP). Secondary objectives aim to identify
      if using the angle of Louis to approximate the location of the right atrium produces
      inaccuracies when measuring JVP. Comparing results in patients breathing spontaneously or
      under positive pressure ventilation will identify if the form of ventilation impacts on JVP
      and CVP recording. Correlating results between physical JVP examination and ultrasound
      assessment of JVP to measure CVP will conclude if ultrasound is a more appropriate tool, in
      an era where the physical examination of the cardiovascular system is becoming less valuable.
Initial exploratory investigations will compare left-sided and right-sided Jugular Venous
      Pressure (JVP) using ultrasonography. Should results show that they are the same, the central
      line is to be placed into the right internal jugular vein when required.

      To begin the trial and whilst the patient is spontaneously breathing, a physical examination
      of the right JVP will be performed. A central line will be inserted with the patient awake
      into the right internal jugular vein. Left-sided ultrasound of JVP and Central Venous
      Pressure (CVP) will be measured using the right-sided catheter will be recorded
      simultaneously. The tip of the catheter attached to the transducer (which is zeroed to the
      reference point) will be placed at the point of venous collapse, identified by
      ultrasonography, to identify if the JVP and CVP match. The tip of the catheter will then be
      placed at the angle of Louis. Measurement of the pressure difference between the angle of
      Louis and the reference point will identify if this value shows variability compared to
      previous approximations of 5cm above the right atrium. With the patient anaesthetised and
      mechanically breathing, left JVP and CVP will be measured once more. Twenty-four hours
      post-surgery, ultrasound of the JVP and CVP will be measured with the patient breathing
      spontaneously.

      The physical JVP examination will be recorded from the opposite side to the central venous
      catheter. The bed will be adjusted to an angle between 30 and 60 degrees, that most clearly
      identifies the collapsing vein. Differentiation between the JVP and the carotid pulse must be
      distinguished. Tangential lighting using a flashlight should be used to correctly identify
      and note the apex of the jugular venous pulsations. Recordings will be taken at
      end-expiration allowing the vertical distance between the venous meniscus and phlebostatic
      axis to be measured. JVP will be measured in millimetres of water.

      Ultrasound recordings will be made using the SonoSite ultrasound probe by Sam Jenkins. The
      equipment and gels required are used routinely on site and will be supplied by Sheffield
      Teaching Hospitals. The SonoSite probe will be calibrated prior to each use, based on the
      recommendations of the manufacturer. The angle of the bed is kept constant and the patient
      will remain in the same position following the physical JVP examination. Ultrasound gel will
      be applied, again on the opposite side to the central venous catheter. Locating the area of
      venous collapse will be identified following visualisation from both longitudinal and
      transverse planes. The apex of venous collapse at end-expiration will be marked using the
      longitudinal view. Corroboration of the correct position of the probe by looking at the
      transverse view will be performed prior to marking of venous collapse.

      CVP will be measured once the central venous catheter has been zeroed. The reference point of
      the transducer will be placed at the 4th intercostal space, mid-axillary line. The bed should
      still be kept at a constant angle for this measurement. The mean of the 'a' wave upon
      end-expiration will be taken. Converting the CVP from millimetres of mercury to millimetres
      of water will allow direct comparison to prior findings of JVP.
observational model: Cohort
time perspective: Retrospective
measure: Ultrasonography
time frame: Through study completion - 30/09/2019
description: Ultrasonography is expected to be a more accurate measure of CVP compared to physical JVP examination and is hypothesised to accurately predict CVP.
arm group label: Heart Valve Surgery
description: Pre-operative patients undergoing heart valve surgery will be selected and data recorded from each patient on the day of their surgery. This patient cohort is required in order to be able to accurately measure their JVP upon physical examination. Patients must have a central line inserted as part of their ongoing clinical management.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United Kingdom
citation: Brennan JM, Blair JE, Goonewardena S, Ronan A, Shah D, Vasaiwala S, Brooks E, Levy A, Kirkpatrick JN, Spencer KT. A comparison by medicine residents of physical examination versus hand-carried ultrasound for estimation of right atrial pressure. Am J Cardiol. 2007 Jun 1;99(11):1614-6. doi: 10.1016/j.amjcard.2007.01.037. Epub 2007 Apr 18.
PMID: 17531592
citation: Cook DJ, Simel DL. The Rational Clinical Examination. Does this patient have abnormal central venous pressure? JAMA. 1996 Feb 28;275(8):630-4. No abstract available.
PMID: 8594245
citation: Deol GR, Collett N, Ashby A, Schmidt GA. Ultrasound accurately reflects the jugular venous examination but underestimates central venous pressure. Chest. 2011 Jan;139(1):95-100. doi: 10.1378/chest.10-1301. Epub 2010 Aug 26.
PMID: 20798190
citation: Fletcher RH, Fletcher SW. Has medicine outgrown physical diagnosis? Ann Intern Med. 1992 Nov 1;117(9):786-7. doi: 10.7326/0003-4819-117-9-786. No abstract available.
PMID: 1416582
citation: Jang T, Aubin C, Naunheim R, Char D. Ultrasonography of the internal jugular vein in patients with dyspnea without jugular venous distention on physical examination. Ann Emerg Med. 2004 Aug;44(2):160-8. doi: 10.1016/j.annemergmed.2004.03.014.
PMID: 15278091
citation: Lipton B. Estimation of central venous pressure by ultrasound of the internal jugular vein. Am J Emerg Med. 2000 Jul;18(4):432-4. doi: 10.1053/ajem.2000.7335.
PMID: 10919533
citation: Mangione S, Nieman LZ. Cardiac auscultatory skills of internal medicine and family practice trainees. A comparison of diagnostic proficiency. JAMA. 1997 Sep 3;278(9):717-22. Erratum In: JAMA 1998 May 13;279(18):1444.
PMID: 9286830
citation: Seth R, Magner P, Matzinger F, van Walraven C. How far is the sternal angle from the mid-right atrium? J Gen Intern Med. 2002 Nov;17(11):852-6. doi: 10.1046/j.1525-1497.2002.20101.x.
PMID: 12406357
citation: Socransky SJ, Wiss R, Robins R, Anawati A, Roy MA, Yeung IC. Defining normal jugular venous pressure with ultrasonography. CJEM. 2010 Jul;12(4):320-4. doi: 10.1017/s1481803500012409.
PMID: 20650024
citation: Sondergaard S, Parkin G, Aneman A. Central venous pressure: we need to bring clinical use into physiological context. Acta Anaesthesiol Scand. 2015 May;59(5):552-60. doi: 10.1111/aas.12490. Epub 2015 Feb 13.
PMID: 25684176
responsible party type: Sponsor