<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/NCT02186197</url>
  </required_header>
  <id_info>
    <org_study_id>206-13</org_study_id>
    <nct_id>NCT02186197</nct_id>
  </id_info>
  <brief_title>The Impact of Fellow-performed Cardiopulmonary Ultrasound Exams</brief_title>
  <official_title>The Impact of Fellow-performed Cardiopulmonary Ultrasound Exams on the Diagnosis and Management of Shock and Respiratory Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beth Israel Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beth Israel Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Shock and respiratory failure are common reasons for admission to the intensive care unit&#xD;
      (ICU) at our institution. The various causes of acute shock and respiratory failure are&#xD;
      traditionally assessed with the use of history, physical examination, chest x-ray, EKG and&#xD;
      laboratory studies. Unfortunately, much of this clinical information is either insensitive or&#xD;
      non-specific. 1 Critical care ultrasound (CCUS) is a rapid and non-invasive tool, which has&#xD;
      been shown to be useful in the intensive care unit to assist in the diagnosis and management&#xD;
      of patients in shock or respiratory failure.2&#xD;
&#xD;
      The investigators hypothesize that the trained fellow's interpretation of critical care&#xD;
      ultrasound images will be accurate when compared to experts and that ultrasounds will change&#xD;
      diagnosis and management of the patient in shock and respiratory failure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In recent years, CCUS has become widely used by clinicians in the field of critical care as a&#xD;
      rapid and non-invasive tool for providing diagnostic information. At Beth Israel Medical&#xD;
      Center, CCUS has been routinely used for over a decade on a daily basis by both fellows and&#xD;
      attending to aid in the diagnosis and management of shock and respiratory failure.&#xD;
&#xD;
      Numerous studies have described the accuracy and speed of clinician-performed critical care&#xD;
      ultrasound. Recently it was shown that early critical care ultrasound by attendings can&#xD;
      modify admitting diagnosis and in many cases change management. This study was done by expert&#xD;
      practitioners and not by trainees. The accuracy of fellow image interpretation or the&#xD;
      proportion of time that a fellow-performed ultrasound exam changes diagnosis or management&#xD;
      has not been studied.&#xD;
&#xD;
      The protocol used in this study has already been implemented as part of the diagnostic&#xD;
      assessment of a critically ill patients in our care and as an educational tool to help&#xD;
      fellows learn ultrasound. The goal of this study is organize the existing clinical data to&#xD;
      determine the accuracy of fellow interpretation along with the diagnostic impact of fellow&#xD;
      performed CCUS.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      This is an observational study to see how accurately subjects (fellows) perform CCUS and what&#xD;
      impact CCUS has on the early diagnosis of shock and respiratory failure in our ICU. This&#xD;
      study involves collection and analysis of ultrasound exam results that are already being&#xD;
      performed and documented as standard practice in our institution.&#xD;
&#xD;
      All pulmonary and critical care fellows who have attended the GNYHA ultrasound course during&#xD;
      fellowship will be eligible for this study. Fellows also will attend pre-existing monthly&#xD;
      lectures to discuss CCUS techniques and cases.&#xD;
&#xD;
      If a patient is to be evaluated in our study they should be newly admitted from the ER and&#xD;
      the ultrasound assessment performed within 30 minutes of arrival to the medical intensive&#xD;
      care unit. A fellow will document their initial indication for ultrasound on a standard&#xD;
      assessment form followed by documentation of how much fluids the patient has received since&#xD;
      admission. Based on the results of physical exam and ancillary testing the fellow will&#xD;
      document pre-ultrasound diagnosis of shock and respiratory failure along with their initial&#xD;
      assessment of whether the patient would respond to fluid bolus administration along with how&#xD;
      much fluids the patient has gotten since arriving from the emergency room. This initial&#xD;
      assessment will also be documented in the qpath database via the ultrasound machine. They&#xD;
      will then document if they believe any diagnostic tests are indicated and the reason for&#xD;
      ordering as well as any therapeutics indicated. They will then document their assessment of&#xD;
      the diagnostic impact of the ultrasound exam to be performed.&#xD;
&#xD;
      A CCUS will then be performed on patients in shock or respiratory failure as is already&#xD;
      protocol in our ICU. The ultrasound exam will be performed within 1 hour of arrival to the&#xD;
      ICU. All images obtained will be saved to a password protected cloud database as is already&#xD;
      our protocol. The ultrasound will require approximately 10 minutes and will not in hold up&#xD;
      other tests or therapeutic interventions. The fellow will document the quality of images&#xD;
      obtained and then pertinent findings on cardiac, lung, renal, vascular and abdominal exam.&#xD;
&#xD;
      Following performance of CCUS, the fellow will document post-ultrasound cause of shock,&#xD;
      respiratory failure and volume responsiveness along with any other findings. They will then&#xD;
      document if any diagnostic or therapeutic management changes are planned that differ from&#xD;
      their pre ultrasound assessment and the reasons for the change in diagnostic or therapeutic&#xD;
      plan.&#xD;
&#xD;
      An assessment of volume responsiveness using a CHEETAH non-invasive cardiac output&#xD;
      hemodynamic monitor will then be performed directly after the ultrasound. This device is&#xD;
      non-invasive and is already being used with frequency in the MICU, SICU and CCU of our&#xD;
      institution to provide non-invasive assessment of whether a patient will respond to fluid&#xD;
      challenge. The result of the test for volume responsiveness will be recorded on the standard&#xD;
      assessment form.&#xD;
&#xD;
      All ultrasound exams will be submitted via the database for review by an attending expert&#xD;
      clinician as is already standard practice in our training program. 72 hours following&#xD;
      admission the ICU attending physician will be asked to document the final diagnosis and cause&#xD;
      of shock or respiratory failure. The final diagnosis will be compared with the&#xD;
      post-ultrasound diagnosis to measure the degree of variation.&#xD;
&#xD;
      The Phillips Sparq ultrasound is the machine most commonly used in our MICU. It has the&#xD;
      ability to save images to a password protected cloud database and will thus be used in this&#xD;
      study.&#xD;
&#xD;
      The study investigators will obtain all SAF's as well as the 'final' diagnosis from the&#xD;
      attending physician at 72hours, and will enter this data into a database that will not&#xD;
      contain any unique patient identifiers.&#xD;
&#xD;
      A waiver of informed consent will be requested in order to use the patients protected health&#xD;
      information. This is appropriate since the research data will be de-identified and will not&#xD;
      impact the patient's medical care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnosis change</measure>
    <time_frame>5 minutes</time_frame>
    <description>The proportion of times that clinical diagnosis changes following performance of a bedside ultrasound.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Management changes</measure>
    <time_frame>5 minutes</time_frame>
    <description>The frequency and type of management changes that are made after performance of a critical care ultrasound.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Volume responsiveness agreement</measure>
    <time_frame>5 minutes</time_frame>
    <description>The proportion of time that post-ultrasound assessment of volume responsiveness agrees with the volume responsiveness conclusion made by a cheetah monitor immediately after ultrasound is performed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ultrasound diagnosis agreement with final diagnosis</measure>
    <time_frame>72 hours following admission to the ICU</time_frame>
    <description>The proportion of the time that ultrasound diagnosis regarding etiology of shock and/or respiratory failure agrees with diagnosis 72 hours later in comparison to the pre-ultrasound clinical diagnosis</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">112</enrollment>
  <condition>Shock</condition>
  <condition>Respiratory Failure</condition>
  <arm_group>
    <arm_group_label>Shock and/or Respiratory Failure</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Critical Care Ultrasound</intervention_name>
    <description>A critical care ultrasound exam will be performed on all patients included in this study</description>
    <arm_group_label>Shock and/or Respiratory Failure</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients admitted to our intensive care unit with shock and/or respiratory failure&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly admitted to the medical ICU.&#xD;
&#xD;
          -  Clinical diagnosis of shock including systolic blood pressure less than 90 mmhg,&#xD;
             patients requiring vasopressors or indication of organ hypoperfusion.&#xD;
&#xD;
          -  Clinical diagnosis of respiratory failure including need for invasive or non-invasive&#xD;
             mechanical ventilation, needing supplemental oxygen more than 50% face mask, clinical&#xD;
             impression of respiratory failure with respiratory rate greater than 25.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients not in shock or respiratory failure based on the above criteria.&#xD;
&#xD;
          -  Patients in shock but with obvious cause of bleeding.&#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>Pierre Kory, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mount Sinai Beth Israel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mount Sinai Beth Israel Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>June 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>July 14, 2015</last_update_submitted>
  <last_update_submitted_qc>July 14, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 15, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Volume Responsiveness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
  </condition_browse>
  <!-- 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/NCT02186197
org study id: 206-13
nct id: NCT02186197
lead sponsor: 
has dmc: Yes
Shock and respiratory failure are common reasons for admission to the intensive care unit
      (ICU) at our institution. The various causes of acute shock and respiratory failure are
      traditionally assessed with the use of history, physical examination, chest x-ray, EKG and
      laboratory studies. Unfortunately, much of this clinical information is either insensitive or
      non-specific. 1 Critical care ultrasound (CCUS) is a rapid and non-invasive tool, which has
      been shown to be useful in the intensive care unit to assist in the diagnosis and management
      of patients in shock or respiratory failure.2

      The investigators hypothesize that the trained fellow's interpretation of critical care
      ultrasound images will be accurate when compared to experts and that ultrasounds will change
      diagnosis and management of the patient in shock and respiratory failure.
In recent years, CCUS has become widely used by clinicians in the field of critical care as a
      rapid and non-invasive tool for providing diagnostic information. At Beth Israel Medical
      Center, CCUS has been routinely used for over a decade on a daily basis by both fellows and
      attending to aid in the diagnosis and management of shock and respiratory failure.

      Numerous studies have described the accuracy and speed of clinician-performed critical care
      ultrasound. Recently it was shown that early critical care ultrasound by attendings can
      modify admitting diagnosis and in many cases change management. This study was done by expert
      practitioners and not by trainees. The accuracy of fellow image interpretation or the
      proportion of time that a fellow-performed ultrasound exam changes diagnosis or management
      has not been studied.

      The protocol used in this study has already been implemented as part of the diagnostic
      assessment of a critically ill patients in our care and as an educational tool to help
      fellows learn ultrasound. The goal of this study is organize the existing clinical data to
      determine the accuracy of fellow interpretation along with the diagnostic impact of fellow
      performed CCUS.

      Methods:

      This is an observational study to see how accurately subjects (fellows) perform CCUS and what
      impact CCUS has on the early diagnosis of shock and respiratory failure in our ICU. This
      study involves collection and analysis of ultrasound exam results that are already being
      performed and documented as standard practice in our institution.

      All pulmonary and critical care fellows who have attended the GNYHA ultrasound course during
      fellowship will be eligible for this study. Fellows also will attend pre-existing monthly
      lectures to discuss CCUS techniques and cases.

      If a patient is to be evaluated in our study they should be newly admitted from the ER and
      the ultrasound assessment performed within 30 minutes of arrival to the medical intensive
      care unit. A fellow will document their initial indication for ultrasound on a standard
      assessment form followed by documentation of how much fluids the patient has received since
      admission. Based on the results of physical exam and ancillary testing the fellow will
      document pre-ultrasound diagnosis of shock and respiratory failure along with their initial
      assessment of whether the patient would respond to fluid bolus administration along with how
      much fluids the patient has gotten since arriving from the emergency room. This initial
      assessment will also be documented in the qpath database via the ultrasound machine. They
      will then document if they believe any diagnostic tests are indicated and the reason for
      ordering as well as any therapeutics indicated. They will then document their assessment of
      the diagnostic impact of the ultrasound exam to be performed.

      A CCUS will then be performed on patients in shock or respiratory failure as is already
      protocol in our ICU. The ultrasound exam will be performed within 1 hour of arrival to the
      ICU. All images obtained will be saved to a password protected cloud database as is already
      our protocol. The ultrasound will require approximately 10 minutes and will not in hold up
      other tests or therapeutic interventions. The fellow will document the quality of images
      obtained and then pertinent findings on cardiac, lung, renal, vascular and abdominal exam.

      Following performance of CCUS, the fellow will document post-ultrasound cause of shock,
      respiratory failure and volume responsiveness along with any other findings. They will then
      document if any diagnostic or therapeutic management changes are planned that differ from
      their pre ultrasound assessment and the reasons for the change in diagnostic or therapeutic
      plan.

      An assessment of volume responsiveness using a CHEETAH non-invasive cardiac output
      hemodynamic monitor will then be performed directly after the ultrasound. This device is
      non-invasive and is already being used with frequency in the MICU, SICU and CCU of our
      institution to provide non-invasive assessment of whether a patient will respond to fluid
      challenge. The result of the test for volume responsiveness will be recorded on the standard
      assessment form.

      All ultrasound exams will be submitted via the database for review by an attending expert
      clinician as is already standard practice in our training program. 72 hours following
      admission the ICU attending physician will be asked to document the final diagnosis and cause
      of shock or respiratory failure. The final diagnosis will be compared with the
      post-ultrasound diagnosis to measure the degree of variation.

      The Phillips Sparq ultrasound is the machine most commonly used in our MICU. It has the
      ability to save images to a password protected cloud database and will thus be used in this
      study.

      The study investigators will obtain all SAF's as well as the 'final' diagnosis from the
      attending physician at 72hours, and will enter this data into a database that will not
      contain any unique patient identifiers.

      A waiver of informed consent will be requested in order to use the patients protected health
      information. This is appropriate since the research data will be de-identified and will not
      impact the patient's medical care.
observational model: Case-Only
time perspective: Prospective
measure: Diagnosis change
time frame: 5 minutes
description: The proportion of times that clinical diagnosis changes following performance of a bedside ultrasound.
measure: Management changes
time frame: 5 minutes
description: The frequency and type of management changes that are made after performance of a critical care ultrasound.
measure: Volume responsiveness agreement
time frame: 5 minutes
description: The proportion of time that post-ultrasound assessment of volume responsiveness agrees with the volume responsiveness conclusion made by a cheetah monitor immediately after ultrasound is performed.
measure: Ultrasound diagnosis agreement with final diagnosis
time frame: 72 hours following admission to the ICU
description: The proportion of the time that ultrasound diagnosis regarding etiology of shock and/or respiratory failure agrees with diagnosis 72 hours later in comparison to the pre-ultrasound clinical diagnosis
arm group label: Shock and/or Respiratory Failure
intervention type: Other
intervention name: Critical Care Ultrasound
description: A critical care ultrasound exam will be performed on all patients included in this study
arm group label: Shock and/or Respiratory Failure
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pierre Kory, MD
role: Principal Investigator
affiliation: Mount Sinai Beth Israel
facility: 
country: United States
responsible party type: Sponsor
mesh term: Respiratory Insufficiency