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/NCT06033560</url>
    </required_header>
    <id_info>
      <org_study_id>RP-D0C3E4</org_study_id>
      <nct_id>NCT06033560</nct_id>
    </id_info>
    <brief_title>The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure</brief_title>
    <acronym>NORMO2</acronym>
    <official_title>The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in SARS-COV-2-related Hypoxemic Respiratory Failure</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Amsterdam UMC, location VUmc</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Amsterdam UMC, location VUmc</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>
        Coronavirus disease (COVID-19) can result in severe hypoxemic respiratory failure that&#xD;
        ultimately may require invasive mechanical ventilation in the Intensive Care Unit (ICU).&#xD;
        Although lifesaving, invasive mechanical ventilation is associated with high mortality,&#xD;
        severe discomfort for patient, long-term sequelae, stress to loved-ones and high costs for&#xD;
        society. During the ongoing pandemic high number of invasively ventilated COVID-19 patients&#xD;
        overwhelmed ICU capacity.&#xD;
  &#xD;
        Non-invasive respiratory support, such as high flow nasal oxygen (HFNO) or non-invasive&#xD;
        ventilation (NIV) have the potential to reduce the risk for invasive mechanical ventilation&#xD;
        and in selected cases ICU admission. However, data from different studies are conflicting and&#xD;
        studies performed in COVID-19 patients are of limited quality. Furthermore, identification of&#xD;
        early predictors of HFNO/NIV treatment failure may prevent unnecessary delay of initiation of&#xD;
        invasive ventilation, which may be associated with adverse clinical outcome. The development&#xD;
        and validation of a prediction model, that incorporates readily available clinically data may&#xD;
        prove pivotal to fine-tune non-invasive respiratory support.&#xD;
  &#xD;
        The overall aim of the NORMO2 project is to investigate the role and risks of HFNO and NIV to&#xD;
        improve outcome in hospitalized hypoxemic COVID-19 patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">September 6, 2022</start_date>
    <completion_date type="Anticipated">November 2023</completion_date>
    <primary_completion_date type="Anticipated">October 2023</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>Proportion of patients requiring invasive mechanical ventilation</measure>
      <time_frame>30 days</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mortality at day 30</measure>
      <time_frame>30 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ICU-free days</measure>
      <time_frame>30 days</time_frame>
    </secondary_outcome>
    <number_of_groups>6</number_of_groups>
    <enrollment type="Anticipated">6000</enrollment>
    <condition>COVID-19</condition>
    <condition>Hypoxemic Respiratory Failure</condition>
    <arm_group>
      <arm_group_label>Full analysis</arm_group_label>
      <description>All eligible patients.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>P/F ratio subgroups</arm_group_label>
      <description>Patients with a P/F ratio split in groups of &lt;=100; 100-150; 150-200</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Respiratory rate subgroups</arm_group_label>
      <description>Patients with a respiratory rate split in groups of &lt;=25; &gt;25 breaths/min</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Body mass index (BMI) subgroups</arm_group_label>
      <description>Patients with BMI split in groups of &lt;=25; 25-30; 30-35; &gt;35 kg/m^2</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Immunocompromised subgroups</arm_group_label>
      <description>Immunocompromised patients due to medication or an underlined condition.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Intensive care unit (ICU) subgroup</arm_group_label>
      <description>Only patients eligible within 24 hours of ICU admission.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>High flow nasal oxygen (HFNO, more than 15 L/min)</intervention_name>
      <description>Non-invasive respiratory support strategy</description>
      <arm_group_label>Body mass index (BMI) subgroups</arm_group_label>
      <arm_group_label>Full analysis</arm_group_label>
      <arm_group_label>Immunocompromised subgroups</arm_group_label>
      <arm_group_label>Intensive care unit (ICU) subgroup</arm_group_label>
      <arm_group_label>P/F ratio subgroups</arm_group_label>
      <arm_group_label>Respiratory rate subgroups</arm_group_label>
      <other_name>Non-invasive ventilation (NIV- Continuous positive airway pressure or bilevel positive airway pressure)</other_name>
      <other_name>Conventional oxygen (COT, between 10 - 15 L/min)</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          80 hospital sites across the United States&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Sars-Cov-2 infection&#xD;
  &#xD;
            -  hospital admission (emergency department, inpatient or ICU)&#xD;
  &#xD;
            -  hypoxemic respiratory failure, defined as P/F ratio below or including 200&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  hypercapnia (PCO2 &gt; 45 mmHG in combination with acidemia (pH &lt; 7.35))&#xD;
  &#xD;
            -  pregnancy&#xD;
  &#xD;
            -  do not resuscitate order&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Erasmus MC</name>
        <address>
          <city>Rotterdam</city>
          <state>Zuid-Holland</state>
          <zip>3015GD</zip>
          <country>Netherlands</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Erasmus Medical Center</investigator_affiliation>
      <investigator_full_name>Prof.dr. L.M.A. Heunks</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <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>No</sharing_ipd>
      <ipd_description>Data is accessible through the National COVID Cohort Collaborative website all relevant code for this project will be made available upon completion.</ipd_description>
    </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/NCT06033560
  org study id: RP-D0C3E4
  nct id: NCT06033560
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Coronavirus disease (COVID-19) can result in severe hypoxemic respiratory failure that
        ultimately may require invasive mechanical ventilation in the Intensive Care Unit (ICU).
        Although lifesaving, invasive mechanical ventilation is associated with high mortality,
        severe discomfort for patient, long-term sequelae, stress to loved-ones and high costs for
        society. During the ongoing pandemic high number of invasively ventilated COVID-19 patients
        overwhelmed ICU capacity.
  
        Non-invasive respiratory support, such as high flow nasal oxygen (HFNO) or non-invasive
        ventilation (NIV) have the potential to reduce the risk for invasive mechanical ventilation
        and in selected cases ICU admission. However, data from different studies are conflicting and
        studies performed in COVID-19 patients are of limited quality. Furthermore, identification of
        early predictors of HFNO/NIV treatment failure may prevent unnecessary delay of initiation of
        invasive ventilation, which may be associated with adverse clinical outcome. The development
        and validation of a prediction model, that incorporates readily available clinically data may
        prove pivotal to fine-tune non-invasive respiratory support.
  
        The overall aim of the NORMO2 project is to investigate the role and risks of HFNO and NIV to
        improve outcome in hospitalized hypoxemic COVID-19 patients.
  observational model: Cohort
  time perspective: Retrospective
  measure: Proportion of patients requiring invasive mechanical ventilation
  time frame: 30 days
  measure: Mortality at day 30
  time frame: 30 days
  measure: ICU-free days
  time frame: 30 days
  arm group label: Full analysis
  description: All eligible patients.
  arm group label: P/F ratio subgroups
  description: Patients with a P/F ratio split in groups of <=100; 100-150; 150-200
  arm group label: Respiratory rate subgroups
  description: Patients with a respiratory rate split in groups of <=25; >25 breaths/min
  arm group label: Body mass index (BMI) subgroups
  description: Patients with BMI split in groups of <=25; 25-30; 30-35; >35 kg/m^2
  arm group label: Immunocompromised subgroups
  description: Immunocompromised patients due to medication or an underlined condition.
  arm group label: Intensive care unit (ICU) subgroup
  description: Only patients eligible within 24 hours of ICU admission.
  intervention type: Device
  intervention name: High flow nasal oxygen (HFNO, more than 15 L/min)
  description: Non-invasive respiratory support strategy
  arm group label: Body mass index (BMI) subgroups
  arm group label: Full analysis
  arm group label: Immunocompromised subgroups
  arm group label: Intensive care unit (ICU) subgroup
  arm group label: P/F ratio subgroups
  arm group label: Respiratory rate subgroups
  other name: Non-invasive ventilation (NIV- Continuous positive airway pressure or bilevel positive airway pressure)
  other name: Conventional oxygen (COT, between 10 - 15 L/min)
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Netherlands
  responsible party type: Principal Investigator
  investigator affiliation: Erasmus Medical Center
  investigator full name: Prof.dr. L.M.A. Heunks
  investigator title: Professor
  mesh term: Respiratory Insufficiency
  sharing ipd: No
  ipd description: Data is accessible through the National COVID Cohort Collaborative website all relevant code for this project will be made available upon completion.