<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/NCT03276364</url>
  </required_header>
  <id_info>
    <org_study_id>206-13</org_study_id>
    <nct_id>NCT03276364</nct_id>
  </id_info>
  <brief_title>The Impact of Point-of-Care Ultrasound</brief_title>
  <official_title>The Impact of Point-of-Care Ultrasound Performed by Trainees to Improve the Prediction of Fluid Responsiveness in Patients With Shock</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Montefiore Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beth Israel Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Montefiore Medical Center</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>
      Point-of-care ultrasound (POCUS) has been found to be useful for aiding in the prediction of&#xD;
      fluid responsiveness. It is unknown if trainees can effectively utilize this tool to improve&#xD;
      their assessment of fluid responsiveness.&#xD;
&#xD;
      In this prospective, observational study, pulmonary and critical care fellows are asked to&#xD;
      make 2 assessments of fluid responsiveness in adults with shock: (1) based on clinical exam&#xD;
      alone (Clinical) and (2) after performing a POCUS (Clinical + US). The accuracy of their pre-&#xD;
      and post-ultrasound assessments are compared using a bioreactance monitor and passive leg&#xD;
      raise test as the gold standard of fluid responsiveness in this study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 21, 2014</start_date>
  <completion_date type="Actual">April 17, 2015</completion_date>
  <primary_completion_date type="Actual">April 17, 2015</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Fluid responsiveness</measure>
    <time_frame>Immediately subsequent to performance of a point-of-care ultrasound exam</time_frame>
    <description>Increase of stroke volume index greater than 10% following passive leg raise testing</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">112</enrollment>
  <condition>Ultrasound</condition>
  <condition>Shock</condition>
  <arm_group>
    <arm_group_label>Shock</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Ultrasound</intervention_name>
    <description>Point-of-care ultrasound examination by pulmonary and critical care fellow</description>
    <arm_group_label>Shock</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        -  Could undergo both a POCUS and bioreactance assessment within 6 hours of admission&#xD;
             from the emergency department or transfer from a medical floor.&#xD;
&#xD;
          -  Shock was defined as either systolic blood pressure less than 90 mmHg or 40 mmHg below&#xD;
             baseline, necessity for vasopressors to maintain mean arterial pressure greater than&#xD;
             65 mmHg, or any evidence of acute organ hypoperfusion that was evident at the time of&#xD;
             study enrollment as judged by the treating physician.&#xD;
&#xD;
          -  The patient needed to be in shock at the time of POCUS and bioreactance testing at&#xD;
             time of enrollment in order to be included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults age 18 or older admitted to the MICU with a diagnosis of shock while a fellow&#xD;
             was on duty.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>September 6, 2017</last_update_submitted>
  <last_update_submitted_qc>September 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Montefiore Medical Center</investigator_affiliation>
    <investigator_full_name>Daniel G. Fein</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shock</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03276364
org study id: 206-13
nct id: NCT03276364
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Point-of-care ultrasound (POCUS) has been found to be useful for aiding in the prediction of
      fluid responsiveness. It is unknown if trainees can effectively utilize this tool to improve
      their assessment of fluid responsiveness.

      In this prospective, observational study, pulmonary and critical care fellows are asked to
      make 2 assessments of fluid responsiveness in adults with shock: (1) based on clinical exam
      alone (Clinical) and (2) after performing a POCUS (Clinical + US). The accuracy of their pre-
      and post-ultrasound assessments are compared using a bioreactance monitor and passive leg
      raise test as the gold standard of fluid responsiveness in this study.
observational model: Cohort
time perspective: Prospective
measure: Fluid responsiveness
time frame: Immediately subsequent to performance of a point-of-care ultrasound exam
description: Increase of stroke volume index greater than 10% following passive leg raise testing
arm group label: Shock
intervention type: Diagnostic Test
intervention name: Ultrasound
description: Point-of-care ultrasound examination by pulmonary and critical care fellow
arm group label: Shock
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
responsible party type: Principal Investigator
investigator affiliation: Montefiore Medical Center
investigator full name: Daniel G. Fein
investigator title: Assistant Professor of Medicine
mesh term: Shock
sharing ipd: Undecided