<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/NCT01723176</url>
  </required_header>
  <id_info>
    <org_study_id>11-408A</org_study_id>
    <nct_id>NCT01723176</nct_id>
  </id_info>
  <brief_title>Evaluation of Ultrasound of the Heart in Patients With Low Blood Pressure</brief_title>
  <official_title>Evaluating Critical Care Echocardiography in Patients With Cardiopulmonary Failure at the Time of Presentation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwell Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwell Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypothesis: Goal-directed echocardiography by trained critical care physicians is equivalent&#xD;
      to that of echocardiography technicians/cardiologists for the purpose of determining etiology&#xD;
      (reason) of cardiopulmonary failure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    study never got off the ground, no pts ever recruited&#xD;
  </why_stopped>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</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>Assessment of left ventricular function</measure>
    <time_frame>within four hours of ICU admission</time_frame>
    <description>Will the assessment of left ventricular function by critical care physicians and echo techs be concordant?</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Presence of Pericardial Effusion and Severity</measure>
    <time_frame>within 4 hrs of ICU admission</time_frame>
    <description>Will the presence of pericardial effusion and severity from critical care physicians and echo techs be concordant?</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Right ventricle dysfunction</measure>
    <time_frame>within 4 hrs of ICU admission</time_frame>
    <description>Will presence of RV dysfunction with critical care physicians versus echo techs/cardiologists be concordant in our population?</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Cardiopulmonary Failure</condition>
  <arm_group>
    <arm_group_label>Patients in Cardiopulmonary Failure</arm_group_label>
    <description>patients in cardiopulmonary failure</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Echocardiography</intervention_name>
    <arm_group_label>Patients in Cardiopulmonary Failure</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who present to the medical intensive care unit with cardiopulmonary failure&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who present to the medical intensive care unit with cardiopulmonary failure&#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>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Justin Weiner, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>NS-LIJ Health System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Long Island Jewish Medical Center</name>
      <address>
        <city>New Hyde Park</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>November 1, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <last_update_submitted>September 24, 2015</last_update_submitted>
  <last_update_submitted_qc>September 24, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwell Health</investigator_affiliation>
    <investigator_full_name>Justin Weiner</investigator_full_name>
    <investigator_title>Chief Fellow, Pulmonary and Critical Care</investigator_title>
  </responsible_party>
  <keyword>goal-directed echocardiography</keyword>
  <keyword>cardiopulmonary failure</keyword>
  <keyword>critical care ultrasound</keyword>
  <!-- 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/NCT01723176
org study id: 11-408A
nct id: NCT01723176
lead sponsor: 
has dmc: No
Hypothesis: Goal-directed echocardiography by trained critical care physicians is equivalent
      to that of echocardiography technicians/cardiologists for the purpose of determining etiology
      (reason) of cardiopulmonary failure.
observational model: Cohort
time perspective: Prospective
measure: Assessment of left ventricular function
time frame: within four hours of ICU admission
description: Will the assessment of left ventricular function by critical care physicians and echo techs be concordant?
measure: Presence of Pericardial Effusion and Severity
time frame: within 4 hrs of ICU admission
description: Will the presence of pericardial effusion and severity from critical care physicians and echo techs be concordant?
measure: Right ventricle dysfunction
time frame: within 4 hrs of ICU admission
description: Will presence of RV dysfunction with critical care physicians versus echo techs/cardiologists be concordant in our population?
arm group label: Patients in Cardiopulmonary Failure
description: patients in cardiopulmonary failure
intervention type: Procedure
intervention name: Echocardiography
arm group label: Patients in Cardiopulmonary Failure
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Justin Weiner, DO
role: Principal Investigator
affiliation: NS-LIJ Health System
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwell Health
investigator full name: Justin Weiner
investigator title: Chief Fellow, Pulmonary and Critical Care