<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/NCT03834246</url>
  </required_header>
  <id_info>
    <org_study_id>Cicit805</org_study_id>
    <nct_id>NCT03834246</nct_id>
  </id_info>
  <brief_title>Smoke Inhalation Injury in Patients Admitted to Intensive Care</brief_title>
  <acronym>fumeintox</acronym>
  <official_title>Prognostic Factors for Smoke Inhalation Injury in Patients Admitted to Intensive Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre d'Investigation Clinique et Technologique 805</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre d'Investigation Clinique et Technologique 805</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>
      Many Studies have shown that the smoke-inhalation injury is responsible for a high mortality&#xD;
      mainly related to the systemic effects of carbon monoxide and cyanide. Respiratory lesions&#xD;
      induced by smoke inhalation, is one of predictive factors of mortality.&#xD;
&#xD;
      The aim of the study is to identify the clinical and epidemiological characteristics of&#xD;
      smoke-inhalation injury and to identify prognostic factors among these patients .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a monocentric, retrospective, descriptive and analytical study , betwen december&#xD;
      1997 and september 2018 in intensive care unit of university of hospital.&#xD;
&#xD;
      All patients aged over 18 year and who had received a diagnosis of smoke- inhalation injury&#xD;
      and were admitted to the ICU of Medical University Hospital , a referral center in Paris&#xD;
      providing HBO therapy , were potentially eligible for inclusion in this investigation.&#xD;
&#xD;
      Criteria used for recommending HBO therapy to a patient with transient or prolonged&#xD;
      unconsciousness, abnormal neurologic findings on physical examination.&#xD;
&#xD;
      Data were analyzed to identify independent factors that may influence mortality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 16, 2018</start_date>
  <completion_date type="Anticipated">May 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>mortality rate</measure>
    <time_frame>20 years</time_frame>
    <description>survival study for the search of prognostic factors</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>epidemiologic characteritics</measure>
    <time_frame>20 years</time_frame>
    <description>description of quantitative and qualitative data</description>
  </secondary_outcome>
  <enrollment type="Anticipated">700</enrollment>
  <condition>Smoke Inhalation Injury</condition>
  <condition>Morality</condition>
  <eligibility>
    <study_pop>
      <textblock>
        We performed a retrospective study of patients admitted to a university affiliated hospital&#xD;
        ICU between December 1997 and september 2018 following smoke -inhalation poisoning.&#xD;
        Outcomes were survival to ICU discharge .&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Men or women over the age of 18&#xD;
&#xD;
          -  Hyperbaric oxygen therapy between 1997 and 2018&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Patients under 18 years old.&#xD;
&#xD;
          -  Patient opposed to the use of his data&#xD;
&#xD;
          -  Patients not treated with hyperbaric oxygen&#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>Rania BOUNAB, dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Raymond Poincaré Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rania BOUNAB, Dr</last_name>
    <phone>+33 (1) 74 10 7778</phone>
    <email>rania.bounab@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Fatima IZEDAREN, CRA</last_name>
    <phone>+33 (1) 47 10 44 49</phone>
    <email>fatima.izedaren@aphp.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Raymond Poincaré</name>
      <address>
        <city>Garches</city>
        <zip>92380</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rania BOUNAB</last_name>
      <phone>0698258796</phone>
      <email>rania.bounab@aphp.fr</email>
    </contact>
    <contact_backup>
      <last_name>rania Bounab</last_name>
      <phone>0147107778</phone>
      <email>rania.bounab@aphp.fr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>You K, Yang HT, Kym D, Yoon J, HaejunYim, Cho YS, Hur J, Chun W, Kim JH. Inhalation injury in burn patients: establishing the link between diagnosis and prognosis. Burns. 2014 Dec;40(8):1470-5. doi: 10.1016/j.burns.2014.09.015. Epub 2014 Oct 16.</citation>
    <PMID>25406889</PMID>
  </reference>
  <reference>
    <citation>Kim Y, Kym D, Hur J, Yoon J, Yim H, Cho YS, Chun W. Does inhalation injury predict mortality in burns patients or require redefinition? PLoS One. 2017 Sep 27;12(9):e0185195. doi: 10.1371/journal.pone.0185195. eCollection 2017.</citation>
    <PMID>28953914</PMID>
  </reference>
  <reference>
    <citation>Darling GE, Keresteci MA, Ibanez D, Pugash RA, Peters WJ, Neligan PC. Pulmonary complications in inhalation injuries with associated cutaneous burn. J Trauma. 1996 Jan;40(1):83-9. doi: 10.1097/00005373-199601000-00016.</citation>
    <PMID>8577005</PMID>
  </reference>
  <reference>
    <citation>Liao WC, Cheng WC, Wu BR, Chen WC, Chen CY, Chen CH, Tu CY, Hsia TC. Outcome and prognostic factors of patients treated in the intensive care unit for carbon monoxide poisoning. J Formos Med Assoc. 2019 Apr;118(4):821-827. doi: 10.1016/j.jfma.2018.09.005. Epub 2018 Oct 5.</citation>
    <PMID>30293927</PMID>
  </reference>
  <reference>
    <citation>Raphael JC, Annane D, Chevret S. Hyperbaric oxygen for acute carbon monoxide poisoning. N Engl J Med. 2003 Feb 6;348(6):557-60; author reply 557-60. No abstract available.</citation>
    <PMID>12572578</PMID>
  </reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>February 6, 2019</last_update_submitted>
  <last_update_submitted_qc>February 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prognostic Factors</keyword>
  <keyword>intensive care unit</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Aspiration</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Smoke Inhalation Injury</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/NCT03834246
org study id: Cicit805
nct id: NCT03834246
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Many Studies have shown that the smoke-inhalation injury is responsible for a high mortality
      mainly related to the systemic effects of carbon monoxide and cyanide. Respiratory lesions
      induced by smoke inhalation, is one of predictive factors of mortality.

      The aim of the study is to identify the clinical and epidemiological characteristics of
      smoke-inhalation injury and to identify prognostic factors among these patients .
The study is a monocentric, retrospective, descriptive and analytical study , betwen december
      1997 and september 2018 in intensive care unit of university of hospital.

      All patients aged over 18 year and who had received a diagnosis of smoke- inhalation injury
      and were admitted to the ICU of Medical University Hospital , a referral center in Paris
      providing HBO therapy , were potentially eligible for inclusion in this investigation.

      Criteria used for recommending HBO therapy to a patient with transient or prolonged
      unconsciousness, abnormal neurologic findings on physical examination.

      Data were analyzed to identify independent factors that may influence mortality.
observational model: Cohort
time perspective: Retrospective
measure: mortality rate
time frame: 20 years
description: survival study for the search of prognostic factors
measure: epidemiologic characteritics
time frame: 20 years
description: description of quantitative and qualitative data
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rania BOUNAB, dr
role: Principal Investigator
affiliation: Raymond Poincaré Hospital
last name: Rania BOUNAB, Dr
phone: +33 (1) 74 10 7778
email: rania.bounab@aphp.fr
last name: Fatima IZEDAREN, CRA
phone: +33 (1) 47 10 44 49
email: fatima.izedaren@aphp.fr
facility: 
status: Recruiting
contact: 
contact backup: 
country: France
citation: You K, Yang HT, Kym D, Yoon J, HaejunYim, Cho YS, Hur J, Chun W, Kim JH. Inhalation injury in burn patients: establishing the link between diagnosis and prognosis. Burns. 2014 Dec;40(8):1470-5. doi: 10.1016/j.burns.2014.09.015. Epub 2014 Oct 16.
PMID: 25406889
citation: Kim Y, Kym D, Hur J, Yoon J, Yim H, Cho YS, Chun W. Does inhalation injury predict mortality in burns patients or require redefinition? PLoS One. 2017 Sep 27;12(9):e0185195. doi: 10.1371/journal.pone.0185195. eCollection 2017.
PMID: 28953914
citation: Darling GE, Keresteci MA, Ibanez D, Pugash RA, Peters WJ, Neligan PC. Pulmonary complications in inhalation injuries with associated cutaneous burn. J Trauma. 1996 Jan;40(1):83-9. doi: 10.1097/00005373-199601000-00016.
PMID: 8577005
citation: Liao WC, Cheng WC, Wu BR, Chen WC, Chen CY, Chen CH, Tu CY, Hsia TC. Outcome and prognostic factors of patients treated in the intensive care unit for carbon monoxide poisoning. J Formos Med Assoc. 2019 Apr;118(4):821-827. doi: 10.1016/j.jfma.2018.09.005. Epub 2018 Oct 5.
PMID: 30293927
citation: Raphael JC, Annane D, Chevret S. Hyperbaric oxygen for acute carbon monoxide poisoning. N Engl J Med. 2003 Feb 6;348(6):557-60; author reply 557-60. No abstract available.
PMID: 12572578
responsible party type: Sponsor
mesh term: Respiratory Aspiration
mesh term: Wounds and Injuries
mesh term: Smoke Inhalation Injury