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/NCT05964244</url>
    </required_header>
    <id_info>
      <org_study_id>FisherPaykel</org_study_id>
      <nct_id>NCT05964244</nct_id>
    </id_info>
    <brief_title>Impact of Noninvasive With Expiratory Washout on Respiratory Rate of Patients With Acute Hypercapnic Respiratory Failure</brief_title>
    <official_title>Evaluate the Impact of Noninvasive (NIV) With Expiratory Washout on Respiratory Rate of Patients With Acute Hypercapnic Respiratory Failure. A Prospective, Randomized Cross Over Pilot Investigation.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fisher and Paykel Healthcare</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fisher and Paykel Healthcare</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study will determine if NIV using the Vela investigational mask with expiratory washout&#xD;
        of the upper airway more effectively reduces respiratory rate in acute patients with&#xD;
        hypercapnic respiratory failure. Patients admitted to hospital with acute respiratory failure&#xD;
        (ARF) will be assessed for hypercapnic ARF by normal hospital protocols. Patients requiring&#xD;
        noninvasive ventilation (NIV) will be set up on NIV as prescribed per standard of care.&#xD;
        Enrollment onto the investigation will occur after the patient has been allowed to stabilize&#xD;
        on NIV . Patients that meet the inclusion/exclusion criteria will be approached for consent.&#xD;
        Investigation participants will receive two masks in random order;&#xD;
  &#xD;
          1. NIV for one hour with the investigational mask (Vela)&#xD;
  &#xD;
          2. NIV for one hour with the standard mask (Nivairo).&#xD;
  &#xD;
        Participants will have their physiological respiratory parameters recorded.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a simple study. Patients who are already on noninvasive ventilation (NIV) for acute&#xD;
        respiratory failure will be approached for the study within the first 24 hours on NIV&#xD;
        therapy.&#xD;
  &#xD;
        The study will be conducted as described above. After the study patients will be able to&#xD;
        choose which mask they continue their NIV on. They will continue NIV as part of their normal&#xD;
        hospital care.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 2023</start_date>
    <completion_date type="Anticipated">May 2024</completion_date>
    <primary_completion_date type="Anticipated">May 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>Crossover Assignment</intervention_model>
      <intervention_model_description>Crossover study where each participant receives NIV on the Vela investigational mask and the Nivairo standard mask for one hour each in random order.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>NIV masks can not be masked during the treatments. Only the analysis will be masked.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in respiratory rate</measure>
      <time_frame>1 hour</time_frame>
      <description>The change in patient's respiratory rate over the 1 hour of the study arm</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Noninvasive Ventilation</condition>
    <arm_group>
      <arm_group_label>Noninvasive ventilation (CPAP or bilevel) with the Vela investigational mask for 1 hour</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Pressure settings for noninvasive ventilation to be set as required to provide optimal respiratory support for each patient. Not to be changed during the 2 hours of the study.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Noninvasive ventilation (CPAP or bilevel) with the standard mask (Nivairo) for 1 hour</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Pressure settings for noninvasive ventilation to be set as required to provide optimal respiratory support for each patient. Not to be changed during the 2 hours of the study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Vela Investigational Mask</intervention_name>
      <description>Wear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy.</description>
      <arm_group_label>Noninvasive ventilation (CPAP or bilevel) with the Vela investigational mask for 1 hour</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Nivairo Standard Mask</intervention_name>
      <description>Wear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy.</description>
      <arm_group_label>Noninvasive ventilation (CPAP or bilevel) with the standard mask (Nivairo) for 1 hour</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Have type II acute respiratory failure (ARF) and have been prescribed NIV&#xD;
  &#xD;
            -  Arterial blood gas (ABG) Partial pressure of arterial carbon dioxide greater or equal&#xD;
               to 6.0 kilopascals (45 millimeters of mercury)&#xD;
  &#xD;
            -  Arterial blood gas acidity greater or equal to 7.35 prior to bilevel commencement&#xD;
  &#xD;
            -  On NIV for 24 hours or less&#xD;
  &#xD;
            -  Negative Covid-19 test&#xD;
  &#xD;
            -  Are 18 years or older&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Contraindicated for NIV&#xD;
  &#xD;
            -  On NIV in Emergency Department/ ward for more than 24 hours, within the last 48 hours&#xD;
  &#xD;
            -  NIV is likely to fail and/or intubation be required, at the doctor's discretion&#xD;
  &#xD;
            -  CPAP or bilevel pressure of 25 centimeters of water or more is required&#xD;
  &#xD;
            -  Unable to tolerate NIV for the duration of the investigation&#xD;
  &#xD;
            -  Do not fit the investigational mask or the standard mask&#xD;
  &#xD;
            -  Pregnancy (tested under standard care)&#xD;
  &#xD;
            -  Agitated&#xD;
  &#xD;
            -  Unable to understand the consent process&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 11, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </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>No IPD will be shared with other researchers.</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/NCT05964244
  org study id: FisherPaykel
  nct id: NCT05964244
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  This study will determine if NIV using the Vela investigational mask with expiratory washout
        of the upper airway more effectively reduces respiratory rate in acute patients with
        hypercapnic respiratory failure. Patients admitted to hospital with acute respiratory failure
        (ARF) will be assessed for hypercapnic ARF by normal hospital protocols. Patients requiring
        noninvasive ventilation (NIV) will be set up on NIV as prescribed per standard of care.
        Enrollment onto the investigation will occur after the patient has been allowed to stabilize
        on NIV . Patients that meet the inclusion/exclusion criteria will be approached for consent.
        Investigation participants will receive two masks in random order;
  
          1. NIV for one hour with the investigational mask (Vela)
  
          2. NIV for one hour with the standard mask (Nivairo).
  
        Participants will have their physiological respiratory parameters recorded.
  This is a simple study. Patients who are already on noninvasive ventilation (NIV) for acute
        respiratory failure will be approached for the study within the first 24 hours on NIV
        therapy.
  
        The study will be conducted as described above. After the study patients will be able to
        choose which mask they continue their NIV on. They will continue NIV as part of their normal
        hospital care.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: Crossover study where each participant receives NIV on the Vela investigational mask and the Nivairo standard mask for one hour each in random order.
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: NIV masks can not be masked during the treatments. Only the analysis will be masked.
  measure: Change in respiratory rate
  time frame: 1 hour
  description: The change in patient's respiratory rate over the 1 hour of the study arm
  arm group label: Noninvasive ventilation (CPAP or bilevel) with the Vela investigational mask for 1 hour
  arm group type: Experimental
  description: Pressure settings for noninvasive ventilation to be set as required to provide optimal respiratory support for each patient. Not to be changed during the 2 hours of the study.
  arm group label: Noninvasive ventilation (CPAP or bilevel) with the standard mask (Nivairo) for 1 hour
  arm group type: Active Comparator
  description: Pressure settings for noninvasive ventilation to be set as required to provide optimal respiratory support for each patient. Not to be changed during the 2 hours of the study.
  intervention type: Device
  intervention name: Vela Investigational Mask
  description: Wear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy.
  arm group label: Noninvasive ventilation (CPAP or bilevel) with the Vela investigational mask for 1 hour
  intervention type: Device
  intervention name: Nivairo Standard Mask
  description: Wear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy.
  arm group label: Noninvasive ventilation (CPAP or bilevel) with the standard mask (Nivairo) for 1 hour
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Respiratory Insufficiency
  sharing ipd: No
  ipd description: No IPD will be shared with other researchers.