<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/NCT01662843</url>
  </required_header>
  <id_info>
    <org_study_id>11-07-FB-0204-HOSP</org_study_id>
    <nct_id>NCT01662843</nct_id>
  </id_info>
  <brief_title>BRIPPED Scan for Evaluation of Emergency Department (ED) Patients With Shortness of Breath</brief_title>
  <acronym>BRIPPED</acronym>
  <official_title>BRIPPED Scan for Evaluation of Emergency Department Patients With Shortness of Breath</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eastern Virginia Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Emergency Medicine Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Eastern Virginia Medical School</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The B-RIPPED scan is a standardized ultrasound evaluation of pulmonary B-lines, Right&#xD;
      ventricle size and strain, Inferior Vena Cava collapsibility, Pleural and Pericardial&#xD;
      Effusion, Pneumothorax, Ejection Fraction, and lower extremity Deep Venous Thrombosis.&#xD;
      Primary outcomes measured are the magnitude of change in differential diagnoses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective randomized control trial will be performed on a convenience sample of 200&#xD;
      patients presenting with undifferentiated SOB to an academic emergency department (ED)&#xD;
      (volume 56,000 patients/year). Subjects are excluded if they have a known history of asthma,&#xD;
      are 20 or more weeks pregnant, or have had thoraco-abdominal trauma in the past 72 hours. The&#xD;
      BRIPPED pilot investigation (IRB #10-02-FB-0026) enrolled 43 patients and physician subjects&#xD;
      from 4/30/2010 to 1/20/2011. This study differs in methodology from the pilot study in the&#xD;
      reduction of the total number of ultrasound images obtained to decrease the total time to&#xD;
      perform the scan. Instead of a cohort study, this randomized control trial includes the&#xD;
      addition of a control group for cost and time saved comparison. As in the pilot study,&#xD;
      eligible patients will be evaluated by the treating ED physician who will rank potential&#xD;
      diagnoses from most to least likely. A study investigator performs the B-RIPPED scan and&#xD;
      provides the initial treating physician with the results. The treating physician will again&#xD;
      be asked to complete a differential diagnosis ranking knowing the B-RIPPED results. Changes&#xD;
      in the differential diagnosis ranking, physician orders, and interventions will be compiled.&#xD;
      A randomized control cohort will be assigned for eligible patients. In the control group, the&#xD;
      treating physician will complete the diagnosis rank list prior to the completion of the&#xD;
      workup, and then once all lab values are back. Time to disposition, and comparison of labs&#xD;
      and radiology tests ordered will be compared to the cohort receiving the BRIPPED scan.&#xD;
      Patients will be assigned a number at time of enrollment, which randomly assigns them to the&#xD;
      control or experimental (patients receiving the BRIPPED scan) group. Packets containing the&#xD;
      appropriate data collection form (control or experimental) will be organized so even numbered&#xD;
      patients will belong to one group, and odd numbered patients will be assigned to the other.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2011</start_date>
  <completion_date type="Actual">May 2012</completion_date>
  <primary_completion_date type="Actual">May 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>magnitude of change of differential diagnosis of the treating physician</measure>
    <time_frame>duration of ED course, which is expected to be an average of 3 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>time to complete the exam</measure>
    <time_frame>3 to 30 minutes during the ED course</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time to disposition in control group compared to group receiving the BRIPPED scan</measure>
    <time_frame>duration of ED course, which is expected to be an average of 3 hours, with a range of 45 minutes to 6 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>labs, consults, medications and other orders added or discontinued after the treating physician is informed of the BRIPPED scan results</measure>
    <time_frame>duration of the ED course, which is expected to be an average of 3 hours, with a range of 45 minutes to 6 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recidivism rates among both cohorts, or evaluation of return to the ED within 30 days</measure>
    <time_frame>30 days after presentation to ED</time_frame>
    <description>Electronic medical record review of patients who present with shortness of breath 30 days after initial presentation, evaluation and treatment</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">104</enrollment>
  <condition>Dyspnea</condition>
  <arm_group>
    <arm_group_label>BRIPPED scan</arm_group_label>
    <description>Patients presenting with undifferentiated shortness of breath who receive the ultrasound scan in addition to standard of care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Patients who only receive the standard of care for undifferentiated shortness of breath</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        A convenience sample of community subjects presenting to an Academic Hospital Emergency&#xD;
        Department (volume approx 60,000 patients per year).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects are included if they are between the ages of 18-89 and present to the Emergency&#xD;
        Department with a chief complaint of shortness of breath or dyspnea.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known history of asthma,&#xD;
&#xD;
          -  are 20 or more weeks pregnant, or&#xD;
&#xD;
          -  have had thoraco-abdominal trauma in the past 72 hours.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Virginia M Stewart, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Eastern Virginia Medical School</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sentara Norfolk General Emergency Department</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2013</verification_date>
  <study_first_submitted>February 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>August 13, 2013</last_update_submitted>
  <last_update_submitted_qc>August 13, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 14, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dyspnea</keyword>
  <keyword>Ultrasonography</keyword>
  <keyword>Emergencies</keyword>
  <keyword>Critical Care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyspnea</mesh_term>
    <mesh_term>Emergencies</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/NCT01662843
org study id: 11-07-FB-0204-HOSP
nct id: NCT01662843
lead sponsor: 
collaborator: 
has dmc: Yes
The B-RIPPED scan is a standardized ultrasound evaluation of pulmonary B-lines, Right
      ventricle size and strain, Inferior Vena Cava collapsibility, Pleural and Pericardial
      Effusion, Pneumothorax, Ejection Fraction, and lower extremity Deep Venous Thrombosis.
      Primary outcomes measured are the magnitude of change in differential diagnoses.
This prospective randomized control trial will be performed on a convenience sample of 200
      patients presenting with undifferentiated SOB to an academic emergency department (ED)
      (volume 56,000 patients/year). Subjects are excluded if they have a known history of asthma,
      are 20 or more weeks pregnant, or have had thoraco-abdominal trauma in the past 72 hours. The
      BRIPPED pilot investigation (IRB #10-02-FB-0026) enrolled 43 patients and physician subjects
      from 4/30/2010 to 1/20/2011. This study differs in methodology from the pilot study in the
      reduction of the total number of ultrasound images obtained to decrease the total time to
      perform the scan. Instead of a cohort study, this randomized control trial includes the
      addition of a control group for cost and time saved comparison. As in the pilot study,
      eligible patients will be evaluated by the treating ED physician who will rank potential
      diagnoses from most to least likely. A study investigator performs the B-RIPPED scan and
      provides the initial treating physician with the results. The treating physician will again
      be asked to complete a differential diagnosis ranking knowing the B-RIPPED results. Changes
      in the differential diagnosis ranking, physician orders, and interventions will be compiled.
      A randomized control cohort will be assigned for eligible patients. In the control group, the
      treating physician will complete the diagnosis rank list prior to the completion of the
      workup, and then once all lab values are back. Time to disposition, and comparison of labs
      and radiology tests ordered will be compared to the cohort receiving the BRIPPED scan.
      Patients will be assigned a number at time of enrollment, which randomly assigns them to the
      control or experimental (patients receiving the BRIPPED scan) group. Packets containing the
      appropriate data collection form (control or experimental) will be organized so even numbered
      patients will belong to one group, and odd numbered patients will be assigned to the other.
observational model: Case-Control
time perspective: Prospective
measure: magnitude of change of differential diagnosis of the treating physician
time frame: duration of ED course, which is expected to be an average of 3 hours
measure: time to complete the exam
time frame: 3 to 30 minutes during the ED course
measure: time to disposition in control group compared to group receiving the BRIPPED scan
time frame: duration of ED course, which is expected to be an average of 3 hours, with a range of 45 minutes to 6 hours
measure: labs, consults, medications and other orders added or discontinued after the treating physician is informed of the BRIPPED scan results
time frame: duration of the ED course, which is expected to be an average of 3 hours, with a range of 45 minutes to 6 hours
measure: Recidivism rates among both cohorts, or evaluation of return to the ED within 30 days
time frame: 30 days after presentation to ED
description: Electronic medical record review of patients who present with shortness of breath 30 days after initial presentation, evaluation and treatment
arm group label: BRIPPED scan
description: Patients presenting with undifferentiated shortness of breath who receive the ultrasound scan in addition to standard of care
arm group label: Control
description: Patients who only receive the standard of care for undifferentiated shortness of breath
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Virginia M Stewart, MD
role: Principal Investigator
affiliation: Eastern Virginia Medical School
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dyspnea
mesh term: Emergencies