xml: <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/NCT05962073</url>
    </required_header>
    <id_info>
      <org_study_id>PreoxyEIT</org_study_id>
      <nct_id>NCT05962073</nct_id>
    </id_info>
    <brief_title>Comparison Physiological Effects According to Preoxygenation Method Using EIT</brief_title>
    <acronym>PreoxyEIT</acronym>
    <official_title>A Pilot Randomized Trial of Preoxygenation Methods and Their Impacts on Endotracheal Intubation in Acute Respiratory Failure: an Electrical Impedance Tomography Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Samsung Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Samsung Medical Center</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>
        Hypoxemia during endotracheal intubation is one of this procedure's most frequent and severe&#xD;
        complications, which can lead to cardiac arrest and other adverse outcomes. Although various&#xD;
        studies have been conducted to ensure the safety of endotracheal intubation, most of them&#xD;
        have focused on the physiological changes during the procedure in surgical settings, where&#xD;
        general anesthesia is administered to healthy subjects. However, the physiological&#xD;
        characteristics of critically ill patients who require endotracheal intubation in the&#xD;
        intensive care unit (ICU) may differ from those of healthy subjects. When comparing the&#xD;
        oxygen saturation-dissociation curve of healthy subjects and critically ill patients, the&#xD;
        latter show a steeper decline in oxygen saturation (SpO2) below 90% when hypoxemia occurs.&#xD;
        Clinically, it is difficult to maintain or recover oxygen saturation when it drops.&#xD;
        Therefore, preoxygenation is also essential for critically ill patients with a relatively&#xD;
        small lung reservoir, as it can help maintain higher and longer oxygen saturation during&#xD;
        endotracheal intubation. For this reason, apneic oxygenation was proposed in the 1950s as a&#xD;
        method of oxygen delivery during general anesthesia for surgery, and clinical randomized&#xD;
        controlled trials (RCTs) applying it to critically ill patients in the ICU have been&#xD;
        conducted since 20 years ago. In an observational study by Macamn et al., the adjusted odds&#xD;
        ratio (OR) of a bag valve mask was 1, while that of a high-flow nasal cannula (HFNC) was 5.75&#xD;
        and that of non-invasive ventilation (NIV) was 0.10 when different preoxygenation methods&#xD;
        were used. n FLORARI 2, a large-scale clinical RCT comparing NIV and HFNC with or without&#xD;
        apneic oxygenation, NIV was significantly more effective than HFNC in reducing severe&#xD;
        hypoxemia. Based on these previous studies, the investigators can infer that supplying oxygen&#xD;
        during laryngoscopy is not very effective in preventing hypoxemia in critically ill patients.&#xD;
        However, there is no guideline on which device to choose for preoxygenation in the ICU, and&#xD;
        NIV or HFNC are selected according to the operator's preference. This is because few studies&#xD;
        have examined the physiological effects of these devices on patients. Therefore, in this&#xD;
        study, the investigators aim to compare the clinical outcomes and adverse events of NIV and&#xD;
        HFNC as preoxygenation methods for endotracheal intubation in critically ill patients with&#xD;
        acute respiratory failure and to evaluate their physiological effects using electrical&#xD;
        impedance tomography.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">July 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 28, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Hypoxemic respiratory failure who required endotracheal intubation</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Lowest SpO2</measure>
      <time_frame>at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)</time_frame>
      <description>Minimum SpO2 value during endotracheal intubation</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>EIT measurement</measure>
      <time_frame>at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)</time_frame>
      <description>Change of T2-T1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EIT measurement</measure>
      <time_frame>at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)</time_frame>
      <description>Change of △EILI</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EIT measurement</measure>
      <time_frame>at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)</time_frame>
      <description>Change of △EELI</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EIT measurement</measure>
      <time_frame>at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)</time_frame>
      <description>Change of Overdistension</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EIT measurement</measure>
      <time_frame>at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)</time_frame>
      <description>Change of Collapse</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EIT measurement</measure>
      <time_frame>at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)</time_frame>
      <description>Change of Global Inhomogeneity Index</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Acute Hypoxemic Respiratory Failure</condition>
    <arm_group>
      <arm_group_label>NIV</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Non-invasive ventilation application for preoxygenation</description>
    </arm_group>
    <arm_group>
      <arm_group_label>HFNC</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>High flow oxygen therapy application for preoxygenation</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>HFNC</intervention_name>
      <description>High-flow oxygen therapy before intubation for preoxygenation</description>
      <arm_group_label>HFNC</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patients aged 18 or older&#xD;
  &#xD;
            -  Acute respiratory failure is defined as follows: Tachypnea over 30 breaths/minute /&#xD;
               Symptoms or signs of respiratory failure / PaO2/FiO2 less than 300&#xD;
  &#xD;
            -  When there is an indication for endotracheal intubation for mechanical ventilation&#xD;
  &#xD;
            -  When sufficient information and a consent form for the study are obtained from the&#xD;
               patient or the patient's guardian&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Coma with Glasgow score &lt; 8&#xD;
  &#xD;
            -  Endotracheal intubation during CPR&#xD;
  &#xD;
            -  Contraindications for NIV: poor patient cooperation, recurrent vomiting, GI bleeding,&#xD;
               severe craniofacial injury, upper airway obstruction, etc.&#xD;
  &#xD;
            -  Contraindications for RSI: complete upper airway obstruction, severe trauma obscuring&#xD;
               cervical structures, etc.&#xD;
  &#xD;
            -  Implanted electronic medical devices (defibrillator, pacemaker or spinal cord&#xD;
               stimulator)&#xD;
  &#xD;
            -  Skin damage or inadequate electrode contact due to wound dressing at the electrode&#xD;
               site&#xD;
  &#xD;
            -  BMI &gt; 50&#xD;
  &#xD;
            -  Polydipsia&#xD;
  &#xD;
            -  Unmeasurable SpO2&#xD;
  &#xD;
            -  Pregnancy or lactation&#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_contact>
      <last_name>Ryoung Eun Ko, MD, PhD</last_name>
      <phone>+82-2-3410-6399</phone>
      <email>koryoungeun@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Eun Jeong Choi</last_name>
      <phone>+82-2-3410-6399</phone>
      <email>graceejchoi@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Samsung Medical Center</name>
        <address>
          <city>Seoul</city>
          <state>Gangnam</state>
          <zip>06351</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <contact>
        <last_name>Hye Rim Chung</last_name>
        <phone>+820234106399</phone>
        <email>hyerim37.jeong@samsung.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 3, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 18, 2023</last_update_submitted>
    <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
      <investigator_full_name>Ryoung-Eun Ko</investigator_full_name>
      <investigator_title>Clinical assistant professor</investigator_title>
    </responsible_party>
    <keyword>electrical impedence tomography</keyword>
    <keyword>preoxygenation</keyword>
    <keyword>intubation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Respiratory Insufficiency</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05962073
  org study id: PreoxyEIT
  nct id: NCT05962073
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Hypoxemia during endotracheal intubation is one of this procedure's most frequent and severe
        complications, which can lead to cardiac arrest and other adverse outcomes. Although various
        studies have been conducted to ensure the safety of endotracheal intubation, most of them
        have focused on the physiological changes during the procedure in surgical settings, where
        general anesthesia is administered to healthy subjects. However, the physiological
        characteristics of critically ill patients who require endotracheal intubation in the
        intensive care unit (ICU) may differ from those of healthy subjects. When comparing the
        oxygen saturation-dissociation curve of healthy subjects and critically ill patients, the
        latter show a steeper decline in oxygen saturation (SpO2) below 90% when hypoxemia occurs.
        Clinically, it is difficult to maintain or recover oxygen saturation when it drops.
        Therefore, preoxygenation is also essential for critically ill patients with a relatively
        small lung reservoir, as it can help maintain higher and longer oxygen saturation during
        endotracheal intubation. For this reason, apneic oxygenation was proposed in the 1950s as a
        method of oxygen delivery during general anesthesia for surgery, and clinical randomized
        controlled trials (RCTs) applying it to critically ill patients in the ICU have been
        conducted since 20 years ago. In an observational study by Macamn et al., the adjusted odds
        ratio (OR) of a bag valve mask was 1, while that of a high-flow nasal cannula (HFNC) was 5.75
        and that of non-invasive ventilation (NIV) was 0.10 when different preoxygenation methods
        were used. n FLORARI 2, a large-scale clinical RCT comparing NIV and HFNC with or without
        apneic oxygenation, NIV was significantly more effective than HFNC in reducing severe
        hypoxemia. Based on these previous studies, the investigators can infer that supplying oxygen
        during laryngoscopy is not very effective in preventing hypoxemia in critically ill patients.
        However, there is no guideline on which device to choose for preoxygenation in the ICU, and
        NIV or HFNC are selected according to the operator's preference. This is because few studies
        have examined the physiological effects of these devices on patients. Therefore, in this
        study, the investigators aim to compare the clinical outcomes and adverse events of NIV and
        HFNC as preoxygenation methods for endotracheal intubation in critically ill patients with
        acute respiratory failure and to evaluate their physiological effects using electrical
        impedance tomography.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Hypoxemic respiratory failure who required endotracheal intubation
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Lowest SpO2
  time frame: at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
  description: Minimum SpO2 value during endotracheal intubation
  measure: EIT measurement
  time frame: at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
  description: Change of T2-T1
  measure: EIT measurement
  time frame: at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
  description: Change of △EILI
  measure: EIT measurement
  time frame: at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
  description: Change of △EELI
  measure: EIT measurement
  time frame: at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
  description: Change of Overdistension
  measure: EIT measurement
  time frame: at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
  description: Change of Collapse
  measure: EIT measurement
  time frame: at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
  description: Change of Global Inhomogeneity Index
  arm group label: NIV
  arm group type: No Intervention
  description: Non-invasive ventilation application for preoxygenation
  arm group label: HFNC
  arm group type: Active Comparator
  description: High flow oxygen therapy application for preoxygenation
  intervention type: Device
  intervention name: HFNC
  description: High-flow oxygen therapy before intubation for preoxygenation
  arm group label: HFNC
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ryoung Eun Ko, MD, PhD
  phone: +82-2-3410-6399
  email: koryoungeun@gmail.com
  last name: Eun Jeong Choi
  phone: +82-2-3410-6399
  email: graceejchoi@gmail.com
  facility: 
  contact: 
  country: Korea, Republic of
  responsible party type: Principal Investigator
  investigator affiliation: Samsung Medical Center
  investigator full name: Ryoung-Eun Ko
  investigator title: Clinical assistant professor
  mesh term: Respiratory Insufficiency
  sharing ipd: Undecided