<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/NCT04489615</url>
  </required_header>
  <id_info>
    <org_study_id>UH Angers</org_study_id>
    <nct_id>NCT04489615</nct_id>
  </id_info>
  <brief_title>Identification of Risk Factors for Alteration of the Cellular-arterial Gradient of CO2</brief_title>
  <acronym>DELTA-CAPNO</acronym>
  <official_title>DELTA-CAPNO: Identification of Risk Factors for Alteration of the Cellular-arterial Gradient of CO2 in Pre-hospital Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Angers</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Angers</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Monocentric, prospective, observational and descriptive study on the evaluation of risk&#xD;
      factors for alteration of the alveoarterial gradient of CO2 in pre-hospital patients,&#xD;
      intubated and then ventilated in an invasive manner; and their impact on intra-arterial&#xD;
      fatehospital.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 3, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>identification of risks factors for alteration of the cellular arterial gradient of CO2 in Pre hospital patients</measure>
    <time_frame>from january 2020 to april 2021</time_frame>
    <description>The main objective is therefore to determine the main risk factors to observe an alteration of the alveoarterial gradient in CO2, at the hospital care (fixed at 10 mmHg).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intrahospital mortality</measure>
    <time_frame>from january 2020 to april 2021</time_frame>
    <description>prognostic evidence of altered alveocapillary gradient on intrahospital mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of hospital admission</measure>
    <time_frame>from january 2020 to april 2021</time_frame>
    <description>the prognosis of the finding of an altered alveocapillary gradient on the time of hospital admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>length of mecanical ventilation</measure>
    <time_frame>from january 2020 to april 2021</time_frame>
    <description>the prognosis of the finding of an altered alveocapillary gradient on the duration of ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurence of pneumonia</measure>
    <time_frame>from january 2020 to april 2021</time_frame>
    <description>the prognosis of the finding of an altered alveocapillary gradient on the occurrence of pneumonia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute respiratory distress syndrom (ARDS)</measure>
    <time_frame>from january 2020 to april 2021</time_frame>
    <description>the prognosis of the finding of an altered alveocapillary gradient on the occurrence of ARDS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay</measure>
    <time_frame>from january 2020 to april 2021</time_frame>
    <description>the prognosis of the finding of an altered alveocapillary gradient on the length of stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intrahospital mortality (subpopulation of traumatized patients which had suffered from intracranial hypertension</measure>
    <time_frame>from january 2020 to april 2021</time_frame>
    <description>prognostic evidence of altered alveocapillary gradient, onset of an episode of intracranial hypertension, and intrahospital survival of severely traumatized patients (GCS &lt; 9).</description>
  </secondary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Mechanical Ventilation</condition>
  <condition>Prehospital Capnography Monitoring</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The patients included are the major patients, intubated and ventilated in pre-hospital,&#xD;
        transferred by the medical team to the University Hospital of Angers.&#xD;
&#xD;
        The ventilation settings are left to the caregiver's discretion, as is the purpose of&#xD;
        Etco2.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age,&#xD;
&#xD;
          -  Endotracheal intubation in pre-hospital and mechanical ventilation,&#xD;
&#xD;
          -  Monitoring of Etco2 in pre-hospital settings&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Identification of a chest wound blowing during pre-hospital care,&#xD;
&#xD;
          -  No technical possibility for performing or analysing arterial sampling,&#xD;
&#xD;
          -  Death during pre-hospital care,&#xD;
&#xD;
          -  A person who has objected to the processing of his data for research at minimal risk&#xD;
             and constraints (category 2) or for research on data, as well as persons subject to&#xD;
             legal protection measures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Quentin qc Carraro, md</last_name>
    <role>Principal Investigator</role>
    <affiliation>UH Angers</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Quentin qc Carraro, md</last_name>
    <phone>778817861</phone>
    <phone_ext>+33</phone_ext>
    <email>quentin.carrar@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Quentin Carraro</name>
      <address>
        <city>Angers</city>
        <zip>49100</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Quentin Carraro</last_name>
      <phone>778817861</phone>
      <phone_ext>+33</phone_ext>
      <email>quentin.carrar@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>November 30, 2020</last_update_submitted>
  <last_update_submitted_qc>November 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>capnography prehospital</keyword>
  <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/NCT04489615
org study id: UH Angers
nct id: NCT04489615
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Monocentric, prospective, observational and descriptive study on the evaluation of risk
      factors for alteration of the alveoarterial gradient of CO2 in pre-hospital patients,
      intubated and then ventilated in an invasive manner; and their impact on intra-arterial
      fatehospital.
observational model: Other
time perspective: Prospective
measure: identification of risks factors for alteration of the cellular arterial gradient of CO2 in Pre hospital patients
time frame: from january 2020 to april 2021
description: The main objective is therefore to determine the main risk factors to observe an alteration of the alveoarterial gradient in CO2, at the hospital care (fixed at 10 mmHg).
measure: Intrahospital mortality
time frame: from january 2020 to april 2021
description: prognostic evidence of altered alveocapillary gradient on intrahospital mortality
measure: Time of hospital admission
time frame: from january 2020 to april 2021
description: the prognosis of the finding of an altered alveocapillary gradient on the time of hospital admission
measure: length of mecanical ventilation
time frame: from january 2020 to april 2021
description: the prognosis of the finding of an altered alveocapillary gradient on the duration of ventilation
measure: Occurence of pneumonia
time frame: from january 2020 to april 2021
description: the prognosis of the finding of an altered alveocapillary gradient on the occurrence of pneumonia
measure: Acute respiratory distress syndrom (ARDS)
time frame: from january 2020 to april 2021
description: the prognosis of the finding of an altered alveocapillary gradient on the occurrence of ARDS
measure: Length of stay
time frame: from january 2020 to april 2021
description: the prognosis of the finding of an altered alveocapillary gradient on the length of stay
measure: Intrahospital mortality (subpopulation of traumatized patients which had suffered from intracranial hypertension
time frame: from january 2020 to april 2021
description: prognostic evidence of altered alveocapillary gradient, onset of an episode of intracranial hypertension, and intrahospital survival of severely traumatized patients (GCS < 9).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Quentin qc Carraro, md
role: Principal Investigator
affiliation: UH Angers
last name: Quentin qc Carraro, md
phone: 778817861
phone ext: +33
email: quentin.carrar@gmail.com
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
sharing ipd: No