<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/NCT03239730</url>
  </required_header>
  <id_info>
    <org_study_id>pH acute dyspnea</org_study_id>
    <nct_id>NCT03239730</nct_id>
  </id_info>
  <brief_title>Arterial pH Selectively Predicts Intensive Care Unit Transfer From the Emergency Department in Obese Patients With Acute Dyspnea</brief_title>
  <official_title>Arterial pH Selectively Predicts ICU Transfer in Obese Patients With Acute Dyspnea Presenting to the Emergency Department: a Prospective Comparative Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Association pour la Formation du Personnel à la Medecine d'Urgence</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Association pour la Formation du Personnel à la Medecine d'Urgence</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 study evaluates the prognostic value of arterial blood gas analysis in a cohort of&#xD;
      Emergency Department patients presenting with shortness of breath of any cause, comparing&#xD;
      obese and non-obese patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Factors associated with admission to intensive care unit (ICU) or ED mortality before&#xD;
      transfer to the ICU are analyzed in obese (BMI ≥ 30kg.m-2) and non-obese patients subgroups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 23, 2013</start_date>
  <completion_date type="Actual">May 30, 2014</completion_date>
  <primary_completion_date type="Actual">May 30, 2014</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>Composite of admission to the ICU or in ED mortality before ICU admission</measure>
    <time_frame>up to 1 day (direct admission to ICU from ED)</time_frame>
    <description>Admission to the ICU following ED management will be at the discretion of the attending ICU physician, and in agreement with current guidelines for ICU admission, according to standard management</description>
  </primary_outcome>
  <enrollment type="Actual">400</enrollment>
  <condition>Dyspnea</condition>
  <condition>Respiratory Failure</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Study population was derived from a cohort of adult patients admitted to the ED with acute&#xD;
        dyspnea&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who presented with acute dyspnea in the ED&#xD;
&#xD;
          -  patients who had an ABG analysis as part of the ED standard management&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with treatment limitation decisions made by the medical teams against ICU&#xD;
             admission, including severe cognitive impairment or palliative care ,&#xD;
&#xD;
          -  Patients with immediate transfer to ICU due to shock and hemodynamic instability at ED&#xD;
             admission&#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>Mustapha SEBBANE, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emergency Department, University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Montpellier University hospital</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <last_update_submitted>August 3, 2017</last_update_submitted>
  <last_update_submitted_qc>August 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>dyspnea</keyword>
  <keyword>pH</keyword>
  <keyword>blood gas analysis</keyword>
  <keyword>emergency department</keyword>
  <keyword>Intensive care unit</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Dyspnea</mesh_term>
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03239730
org study id: pH acute dyspnea
nct id: NCT03239730
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the prognostic value of arterial blood gas analysis in a cohort of
      Emergency Department patients presenting with shortness of breath of any cause, comparing
      obese and non-obese patients.
Factors associated with admission to intensive care unit (ICU) or ED mortality before
      transfer to the ICU are analyzed in obese (BMI ≥ 30kg.m-2) and non-obese patients subgroups.
observational model: Cohort
time perspective: Prospective
measure: Composite of admission to the ICU or in ED mortality before ICU admission
time frame: up to 1 day (direct admission to ICU from ED)
description: Admission to the ICU following ED management will be at the discretion of the attending ICU physician, and in agreement with current guidelines for ICU admission, according to standard management
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mustapha SEBBANE, MD, PhD
role: Principal Investigator
affiliation: Emergency Department, University Hospital, Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: Respiratory Insufficiency
mesh term: Dyspnea
mesh term: Emergencies
sharing ipd: No