<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/NCT01699880</url>
  </required_header>
  <id_info>
    <org_study_id>HLM_JDR1</org_study_id>
    <nct_id>NCT01699880</nct_id>
  </id_info>
  <brief_title>Efficacy of High Flow Nasal Cannula Oxygen to Reduce Desaturation During Tracheal Intubation</brief_title>
  <acronym>HAPI</acronym>
  <official_title>High Flow Nasal Cannula Oxygen for Pre and During Procedure Oxygenation During Tracheal Intubation: Comparison With High FiO2 Non Rebreathing Bag Reservoir Facemasks</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 of critically ill patients is associated in the intensive care unit (ICU)&#xD;
      with significant complications and morbidity. Patient desaturation is one of the most common&#xD;
      complications that may lead to cardiac arrest despite pre-intubation oxygenation.&#xD;
      Preoxygenation can be improved by the use of non-invasive ventilation, but this technique can&#xD;
      be cumbersome to implement in the context of urgent intubation and more importantly it does&#xD;
      not insure oxygenation during intubation. High flow nasal cannula oxygen therapy is a&#xD;
      technique that has been shown to improve patient oxygenation in the context of acute&#xD;
      hypoxemic respiratory failure. It bears the potential to be of clinical benefit in the&#xD;
      setting of tracheal intubation in the ICU to ensure patient safety. The purpose of this study&#xD;
      is to compare pre- and per-intubation (during intubation) oxygenation with either a&#xD;
      conventional high FiO2 oxygen bag reservoir facemask (current standard practice) or high flow&#xD;
      nasal cannula oxygen therapy (new practice to be implemented in our ICU).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pre-oxygenation is ensured in our ICU with a high FiO2 nonrebreathing facemask, except in&#xD;
      patients already under high flow nasal cannula oxygen therapy because of acute hypoxemic&#xD;
      respiratory failure. A nasal catheter is positioned to ensure a low oxygen flow during&#xD;
      laryngoscopy. Whether or not all patients should benefit from high flow nasal cannula oxygen&#xD;
      therapy for pre-oxygenation remains unknown. In order to improve quality of care delivered to&#xD;
      our patients and in anticipation of a change in our practice, we decided to record&#xD;
      prospectively oxygen parameters during and immediately of intubation using a facemask and to&#xD;
      compare them with parameters obtained in patients intubated after our change in practice. The&#xD;
      change of practice consists in the systematic use of high flow nasal cannula oxygen therapy&#xD;
      to ensure pre and during procedure (tracheal intubation)oxygenation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2011</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">November 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>lowest pulse oxymetry (SpO2) during intubation</measure>
    <time_frame>from beginning of laryngoscopy to completed intubation</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>mean pulse oxymetry during intubation</measure>
    <time_frame>from beginning of laryngoscopy to completed intubation</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>pulse oxymetry after preoxygenation</measure>
    <time_frame>3min prexoxygenation</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>pulse oxymetry after intubation</measure>
    <time_frame>at connection of the patient to the ventilator</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>mean pulse oxymetry</measure>
    <time_frame>one, five and thirty minutes after intubation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of pulse oxymetry below 90%</measure>
    <time_frame>from laryngoscopy to 30 minutes once tracheal intubation completed</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of pulse oxymetry below 80%</measure>
    <time_frame>from laryngoscopy to 30 minutes once tracheal intubation completed</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>cardiac arrest</measure>
    <time_frame>during and immediately after procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>hemodynamic instability defined as arterial systolic blood pressure below 80 mmHg</measure>
    <time_frame>during and immediately after procedure</time_frame>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">101</enrollment>
  <condition>Need for Intubation</condition>
  <condition>Oxygenation Before and During Intubation</condition>
  <arm_group>
    <arm_group_label>conventional high FiO2 bag reservoir facemask</arm_group_label>
    <description>this group of patients is intubated according to our current practice that requires the use of a high FiO2 nonrebreathing with bag reservoir facemask to ensure preoxygenation in patients requiring tracheal intubation. a small nasal catheter is inserted just before laryngoscopy to ensure a low oxygen flow to allow oxygenation during laryngoscopy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>high flow nasal cannula oxygen</arm_group_label>
    <description>we wish to change our standard practice of preoxygenation and expand our use of high flow nasal cannula oxygen therapy to the tracheal intubation setting. Currently, used of high flow oxygen nasal cannula oxygen therapy to ensure oxygenation during intubation is limited to the patients already under high flow nasal cannula oxygen. the change of practice consists in the systematic use of high flow nasal cannula oxygen therapy in all patients requiring tracheal intubation in the ICU.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        ICU patients requiring tracheal intubation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ICU patient requiring tracheal intubation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt; 18 years&#xD;
&#xD;
          -  cardiac arrest&#xD;
&#xD;
          -  acute respiratory failure requiring immediate high flow nasal cannula oxygen, defined&#xD;
             as patient with SpO2 &lt; 95% while under 15 L:min oxygen with a nonrebreathing facemask&#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>Hopital Louis Mourier, AP-HP, Colombes, France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medico-surgical ICU</name>
      <address>
        <city>Colombes</city>
        <zip>92701</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <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>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, 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>Lenglet H, Sztrymf B, Leroy C, Brun P, Dreyfuss D, Ricard JD. Humidified high flow nasal oxygen during respiratory failure in the emergency department: feasibility and efficacy. Respir Care. 2012 Nov;57(11):1873-8. doi: 10.4187/respcare.01575. Epub 2012 Mar 13.</citation>
    <PMID>22417844</PMID>
  </reference>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>August 11, 2014</last_update_submitted>
  <last_update_submitted_qc>August 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 12, 2014</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>tracheal intubation</keyword>
  <keyword>preoxygenation</keyword>
  <keyword>desaturation</keyword>
  <keyword>hypoxemia</keyword>
  <keyword>oxygen therapy</keyword>
  <keyword>high flow nasal cannula oxygen therapy</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/NCT01699880
org study id: HLM_JDR1
nct id: NCT01699880
lead sponsor: 
has dmc: No
Tracheal intubation of critically ill patients is associated in the intensive care unit (ICU)
      with significant complications and morbidity. Patient desaturation is one of the most common
      complications that may lead to cardiac arrest despite pre-intubation oxygenation.
      Preoxygenation can be improved by the use of non-invasive ventilation, but this technique can
      be cumbersome to implement in the context of urgent intubation and more importantly it does
      not insure oxygenation during intubation. High flow nasal cannula oxygen therapy is a
      technique that has been shown to improve patient oxygenation in the context of acute
      hypoxemic respiratory failure. It bears the potential to be of clinical benefit in the
      setting of tracheal intubation in the ICU to ensure patient safety. The purpose of this study
      is to compare pre- and per-intubation (during intubation) oxygenation with either a
      conventional high FiO2 oxygen bag reservoir facemask (current standard practice) or high flow
      nasal cannula oxygen therapy (new practice to be implemented in our ICU).
Pre-oxygenation is ensured in our ICU with a high FiO2 nonrebreathing facemask, except in
      patients already under high flow nasal cannula oxygen therapy because of acute hypoxemic
      respiratory failure. A nasal catheter is positioned to ensure a low oxygen flow during
      laryngoscopy. Whether or not all patients should benefit from high flow nasal cannula oxygen
      therapy for pre-oxygenation remains unknown. In order to improve quality of care delivered to
      our patients and in anticipation of a change in our practice, we decided to record
      prospectively oxygen parameters during and immediately of intubation using a facemask and to
      compare them with parameters obtained in patients intubated after our change in practice. The
      change of practice consists in the systematic use of high flow nasal cannula oxygen therapy
      to ensure pre and during procedure (tracheal intubation)oxygenation.
observational model: Case-Control
time perspective: Prospective
measure: lowest pulse oxymetry (SpO2) during intubation
time frame: from beginning of laryngoscopy to completed intubation
measure: mean pulse oxymetry during intubation
time frame: from beginning of laryngoscopy to completed intubation
measure: pulse oxymetry after preoxygenation
time frame: 3min prexoxygenation
measure: pulse oxymetry after intubation
time frame: at connection of the patient to the ventilator
measure: mean pulse oxymetry
time frame: one, five and thirty minutes after intubation
measure: number of pulse oxymetry below 90%
time frame: from laryngoscopy to 30 minutes once tracheal intubation completed
measure: number of pulse oxymetry below 80%
time frame: from laryngoscopy to 30 minutes once tracheal intubation completed
measure: cardiac arrest
time frame: during and immediately after procedure
measure: hemodynamic instability defined as arterial systolic blood pressure below 80 mmHg
time frame: during and immediately after procedure
arm group label: conventional high FiO2 bag reservoir facemask
description: this group of patients is intubated according to our current practice that requires the use of a high FiO2 nonrebreathing with bag reservoir facemask to ensure preoxygenation in patients requiring tracheal intubation. a small nasal catheter is inserted just before laryngoscopy to ensure a low oxygen flow to allow oxygenation during laryngoscopy.
arm group label: high flow nasal cannula oxygen
description: we wish to change our standard practice of preoxygenation and expand our use of high flow nasal cannula oxygen therapy to the tracheal intubation setting. Currently, used of high flow oxygen nasal cannula oxygen therapy to ensure oxygenation during intubation is limited to the patients already under high flow nasal cannula oxygen. the change of practice consists in the systematic use of high flow nasal cannula oxygen therapy in all patients requiring tracheal intubation in the ICU.
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: Hopital Louis Mourier, AP-HP, Colombes, France
facility: 
country: France
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: 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, 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: Lenglet H, Sztrymf B, Leroy C, Brun P, Dreyfuss D, Ricard JD. Humidified high flow nasal oxygen during respiratory failure in the emergency department: feasibility and efficacy. Respir Care. 2012 Nov;57(11):1873-8. doi: 10.4187/respcare.01575. Epub 2012 Mar 13.
PMID: 22417844
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