<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/NCT02214576</url>
  </required_header>
  <id_info>
    <org_study_id>HLM_JDR2</org_study_id>
    <nct_id>NCT02214576</nct_id>
  </id_info>
  <brief_title>High Flow Nasal Canula Oxygen Helps Preoxygenate ARDS Patients</brief_title>
  <acronym>HIGHER</acronym>
  <official_title>Observational Study of High Flow Nasal Canula Oxygen to Preoxygenate ARDS Patients That Require Intubation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hôpital Louis Mourier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hôpital Louis Mourier</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Tracheal intubation in the ICU is associated with significant complications and morbidity.&#xD;
      Desaturation is among the most frequent and hazardous complication, occurring in almost one&#xD;
      out of four intubations, that may in some instances lead to cardiac arrest; despite&#xD;
      appropriate preoxygenation. Non-invasive ventilation may help improve preoxygenation but does&#xD;
      not allow for apneic oxygenation and may not be performed in patients with neurological&#xD;
      impairment. High flow nasal canula oxygen is increasingly used in the ICU in patients with&#xD;
      acute hypoxemic respiratory failure and may be used to improve preoxygenation. It is&#xD;
      currently used in our ICU for that purpose. Because high flow nasal canula oxygen is our&#xD;
      first line oxyten therapy for patients with acute respirtory distress syndrome, we sought to&#xD;
      determine its use as a means to ensure preoxygenation in those ARDS patients that require&#xD;
      intubation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      High flow nasal canula oxygen is increasingly used to provide heated and humidified oxygen in&#xD;
      patients with acute respiratory failure. One of the major advantages of high flow nasal&#xD;
      canula oxygen is the possibility to maintain oxygenation during laryngoscopy and thereby&#xD;
      providing high flow apneic oxygenation. In addition, and contrary no non-invasive&#xD;
      ventilation, preoxygenation may be used in patients with neurological impairment. Finally,&#xD;
      the interest of this device is that it is the same that is maintained throughout the whole&#xD;
      management of the patient, from ICU admission to intubation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</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>Oxygen saturation</measure>
    <time_frame>30 minutes</time_frame>
    <description>oxygen saturation measured by pulse oxymetry during intubation and compared to levels before intubation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>complications</measure>
    <time_frame>60 minutes</time_frame>
    <description>arrhythmia, hypotension, profound desaturation, cardiac arrest</description>
  </secondary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Acute Respiratory Distress Syndrome</condition>
  <eligibility>
    <study_pop>
      <textblock>
        acute respiratory distress syndrome patients that require tracheal intubation in the ICU&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ARDS according to the Berlin criteria&#xD;
&#xD;
          -  use of high flow nasal canula oxygen&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#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>Jean-Damien RICARD, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Paris Diderot and Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medico-surgical ICU, Louis Mourier Hospital</name>
      <address>
        <city>Colombes</city>
        <zip>92700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Ricard JD. High flow nasal oxygen in acute respiratory failure. Minerva Anestesiol. 2012 Jul;78(7):836-41. Epub 2012 Apr 24.</citation>
    <PMID>22531566</PMID>
  </reference>
  <reference>
    <citation>Sztrymf B, Messika J, Bertrand F, Hurel D, Leon R, Dreyfuss D, Ricard JD. Beneficial effects of humidified high flow nasal oxygen in critical care patients: a prospective pilot study. Intensive Care Med. 2011 Nov;37(11):1780-6. doi: 10.1007/s00134-011-2354-6. Epub 2011 Sep 27.</citation>
    <PMID>21946925</PMID>
  </reference>
  <reference>
    <citation>Sztrymf B, Messika J, Mayot T, Lenglet H, Dreyfuss D, Ricard JD. Impact of high-flow nasal cannula oxygen therapy on intensive care unit patients with acute respiratory failure: a prospective observational study. J Crit Care. 2012 Jun;27(3):324.e9-13. doi: 10.1016/j.jcrc.2011.07.075. Epub 2011 Sep 29.</citation>
    <PMID>21958974</PMID>
  </reference>
  <reference>
    <citation>Messika J, Ben Ahmed K, Gaudry S, Miguel-Montanes R, Rafat C, Sztrymf B, Dreyfuss D, Ricard JD. Use of High-Flow Nasal Cannula Oxygen Therapy in Subjects With ARDS: A 1-Year Observational Study. Respir Care. 2015 Feb;60(2):162-9. doi: 10.4187/respcare.03423. Epub 2014 Nov 4.</citation>
    <PMID>25371400</PMID>
  </reference>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>August 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>August 13, 2015</last_update_submitted>
  <last_update_submitted_qc>August 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 14, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hôpital Louis Mourier</investigator_affiliation>
    <investigator_full_name>Prof Jean-Damien RICARD</investigator_full_name>
    <investigator_title>Professor of Intensive Care Medicine, Assistant-head of ICU</investigator_title>
  </responsible_party>
  <keyword>Respiratory Distress Syndrome, Adult</keyword>
  <keyword>intubation, intratracheal</keyword>
  <keyword>Oxygen Inhalation Therapy</keyword>
  <keyword>Positive-Pressure Respiration</keyword>
  <keyword>laryngoscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Acute Lung 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/NCT02214576
org study id: HLM_JDR2
nct id: NCT02214576
lead sponsor: 
has dmc: No
Tracheal intubation in the ICU is associated with significant complications and morbidity.
      Desaturation is among the most frequent and hazardous complication, occurring in almost one
      out of four intubations, that may in some instances lead to cardiac arrest; despite
      appropriate preoxygenation. Non-invasive ventilation may help improve preoxygenation but does
      not allow for apneic oxygenation and may not be performed in patients with neurological
      impairment. High flow nasal canula oxygen is increasingly used in the ICU in patients with
      acute hypoxemic respiratory failure and may be used to improve preoxygenation. It is
      currently used in our ICU for that purpose. Because high flow nasal canula oxygen is our
      first line oxyten therapy for patients with acute respirtory distress syndrome, we sought to
      determine its use as a means to ensure preoxygenation in those ARDS patients that require
      intubation.
High flow nasal canula oxygen is increasingly used to provide heated and humidified oxygen in
      patients with acute respiratory failure. One of the major advantages of high flow nasal
      canula oxygen is the possibility to maintain oxygenation during laryngoscopy and thereby
      providing high flow apneic oxygenation. In addition, and contrary no non-invasive
      ventilation, preoxygenation may be used in patients with neurological impairment. Finally,
      the interest of this device is that it is the same that is maintained throughout the whole
      management of the patient, from ICU admission to intubation.
observational model: Cohort
time perspective: Prospective
measure: Oxygen saturation
time frame: 30 minutes
description: oxygen saturation measured by pulse oxymetry during intubation and compared to levels before intubation
measure: complications
time frame: 60 minutes
description: arrhythmia, hypotension, profound desaturation, cardiac arrest
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Damien RICARD, MD, PhD
role: Principal Investigator
affiliation: University Paris Diderot and Assistance Publique - Hôpitaux de Paris
facility: 
country: France
citation: Ricard JD. High flow nasal oxygen in acute respiratory failure. Minerva Anestesiol. 2012 Jul;78(7):836-41. Epub 2012 Apr 24.
PMID: 22531566
citation: Sztrymf B, Messika J, Bertrand F, Hurel D, Leon R, Dreyfuss D, Ricard JD. Beneficial effects of humidified high flow nasal oxygen in critical care patients: a prospective pilot study. Intensive Care Med. 2011 Nov;37(11):1780-6. doi: 10.1007/s00134-011-2354-6. Epub 2011 Sep 27.
PMID: 21946925
citation: Sztrymf B, Messika J, Mayot T, Lenglet H, Dreyfuss D, Ricard JD. Impact of high-flow nasal cannula oxygen therapy on intensive care unit patients with acute respiratory failure: a prospective observational study. J Crit Care. 2012 Jun;27(3):324.e9-13. doi: 10.1016/j.jcrc.2011.07.075. Epub 2011 Sep 29.
PMID: 21958974
citation: Messika J, Ben Ahmed K, Gaudry S, Miguel-Montanes R, Rafat C, Sztrymf B, Dreyfuss D, Ricard JD. Use of High-Flow Nasal Cannula Oxygen Therapy in Subjects With ARDS: A 1-Year Observational Study. Respir Care. 2015 Feb;60(2):162-9. doi: 10.4187/respcare.03423. Epub 2014 Nov 4.
PMID: 25371400
responsible party type: Principal Investigator
investigator affiliation: Hôpital Louis Mourier
investigator full name: Prof Jean-Damien RICARD
investigator title: Professor of Intensive Care Medicine, Assistant-head of ICU
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Acute Lung Injury