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/NCT06007495</url>
    </required_header>
    <id_info>
      <org_study_id>CIP_336</org_study_id>
      <nct_id>NCT06007495</nct_id>
    </id_info>
    <brief_title>Pilot Physiological Evaluation of an Investigational Mask With Expiratory Washout.</brief_title>
    <official_title>Pilot Physiological Evaluation of an Investigational Mask With Expiratory Washout.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fisher and Paykel Healthcare</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Institut universitaire de cardiologie et de pneumologie de Québec, University Laval</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Centre hospitalier de l'Université de Montréal (CHUM)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </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>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this pilot randomized cross-over study is to compare the effect of a full-face&#xD;
        mask with expiratory washout to a conventional full face mask on non-invasive ventilation&#xD;
        (NIV) in patients with acute hypercapnic, and acute hypoxemic, respiratory failure. The main&#xD;
        questions it aims to answer are:&#xD;
  &#xD;
          -  Does a mask with expiratory washout improve minute ventilation in patients using&#xD;
             non-invasive ventilation compared with a conventional single-limb NIV mask&#xD;
  &#xD;
          -  How does a mask with expiratory washout affect respiratory variables compared with a&#xD;
             dual-limb NIV mask.&#xD;
  &#xD;
        Participants already prescribed NIV will undergo 3 arms of the investigation in a randomized&#xD;
        order:&#xD;
  &#xD;
          -  Single-limb NIV with investigation mask (with expiratory washout)&#xD;
  &#xD;
          -  Single-limb NIV with conventional mask&#xD;
  &#xD;
          -  Dual-limb NIV with conventional mask&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The investigational mask has been designed to deliver non-invasive ventilation (NIV) therapy&#xD;
        with expiratory washout.&#xD;
  &#xD;
        Expiratory washout is a technique designed to flush the upper airway of carbon dioxide at the&#xD;
        end of expiration. During conventional NIV the gas at end of exhalation contributes to the&#xD;
        functional dead space and &quot;wasted&quot; ventilation. The primary purpose of expiratory washout is&#xD;
        to flush the upper airway with fresh gas during exhalation so the next supported breath which&#xD;
        drives gas back into the alveolar regions has reduced carbon dioxide.&#xD;
  &#xD;
        Patients that are admitted to hospital with acute (hypercapnic or hypoxemic) respiratory&#xD;
        failure, as assessed by normal hospital protocols, and starting or prescribed to start NIV&#xD;
        therapy will be considered for the investigation. Once stabilized on NIV by the physician in&#xD;
        charge of their care, eligible patients will be assessed against the inclusion/exclusion&#xD;
        criteria and enrolled into the study if applicable.&#xD;
  &#xD;
        Participants that are enrolled into the study will be put onto oxygen therapy via nasal&#xD;
        cannula for 15 minutes, during which time baseline measurements of physiological parameters&#xD;
        (such as respiratory rate, tidal volume, minute ventilation and blood gases) and dyspnea&#xD;
        scores will be recorded.&#xD;
  &#xD;
        Following baseline measurements, 32 participants will be randomized into one of the 3&#xD;
        investigational arms and receive NIV with heated humidification according to the&#xD;
        randomization protocol for 30 minutes each arm (90 minutes total). The same measurements will&#xD;
        be recorded at the end of each 30-minute investigational arm. Participants will cross over to&#xD;
        the other 2 conditions consecutively in a random order, each for 30 minutes.&#xD;
  &#xD;
        The ventilator settings (press support ventilation (PSV), positive end expiratory pressure&#xD;
        (PEEP)) will be the following: PSV for tidal volume comprised between 6 and 8 millilitres per&#xD;
        kilogram (ml/kg) predicted body weight (PBW), a titration period will be planned at the&#xD;
        beginning of the first study period to target a tidal volume of 7 +/-1 ml/kg PBW and the PSV&#xD;
        level will be kept constant thereafter. PEEP will be set according to the physician in charge&#xD;
        (between 5 and 10 centimetres of water (cmH2O)) if NIV was used before inclusion or will be&#xD;
        set by the investigators between 5 and 10 cmH2O. The fraction of inspired oxygen will be&#xD;
        titrated manually to target peripheral saturation of oxygen of 88-92% in patients with&#xD;
        hypercapnia and 90-94% in patients without hypercapnia.&#xD;
  &#xD;
        Once the investigation is complete, and participants have successfully finished all 3 arms of&#xD;
        NIV therapy, the standard NIV protocols as per local hospital will resume, and participants&#xD;
        will return to the care of their usual physician.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">February 2025</completion_date>
    <primary_completion_date type="Anticipated">February 2025</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>Randomized Cross-Over study</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Minute Ventilation</measure>
      <time_frame>Recorded at baseline and the end of each 30-minute period of non-invasive ventilation over 1 hour and 30 minutes of data measurement</time_frame>
      <description>Variations of the minute ventilation in the three different arms (Investigational mask, single-limb conventional, dual-limb conventional)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Tidal Volume</measure>
      <time_frame>Recorded at baseline and the end of each 30-minute period of non-invasive ventilation over 1 hour and 30 minutes of data measurement</time_frame>
      <description>Changes in tidal volume over the three different arms</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Respiratory Rate</measure>
      <time_frame>Recorded at baseline and the end of each 30-minute period of non-invasive ventilation over 1 hour and 30 minutes of data measurement</time_frame>
      <description>Changes in respiratory rate over the three different arms</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood gases</measure>
      <time_frame>Recorded at baseline and the end of each 30-minute period of non-invasive ventilation over 1 hour and 30 minutes of data measurement</time_frame>
      <description>Changes in blood gas values over the three different arms</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dyspnoea Score</measure>
      <time_frame>Recorded at baseline and the end of each 30-minute period of non-invasive ventilation over 1 hour and 30 minutes of data measurement</time_frame>
      <description>Changes in dyspnea score over the three different arms. Dyspnea measured with the modified Borg dyspnea score, which utilizes a scale of 0 to 10 where 0 represents no dyspnea and 10 represents maximal dyspnea.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mask Comfort Score</measure>
      <time_frame>Recorded at baseline and the end of each 30-minute period of non-invasive ventilation over 1 hour and 30 minutes of data measurement</time_frame>
      <description>Changes in mask comfort score over the three different arms. Mask comfort will be measured with a subjective likert scale of comfort where 1 represents maximal comfort, and 5 represents least comfort.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">32</enrollment>
    <condition>Acute Hypercapnic Respiratory Failure</condition>
    <condition>Acute Hypoxemic Respiratory Failure</condition>
    <arm_group>
      <arm_group_label>Single-limb non-invasive ventilation with expiratory washout</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In a random order, 30 minute period of non-invasive ventilation using the investigational mask, a vented full-face mask with expiratory washout</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Single-limb non-invasive ventilation</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>In a random order, 30 minute period of non-invasive ventilation with a conventional vented full-face mask (RT077 or equivalent)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dual-limb non-invasive ventilation</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>In a random order, 30 minute period of non-invasive ventilation with a conventional vented full-face mask (RT076 or equivalent)</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Investigational full-face mask with expiratory washout</intervention_name>
      <description>With cross-over in randomized order, mask worn for 30 minutes with prescribed single-limb non-invasive ventilation</description>
      <arm_group_label>Single-limb non-invasive ventilation with expiratory washout</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Conventional full-face mask - single-limb</intervention_name>
      <description>With cross-over in randomized order, conventional mask such as RT077, worn for 30 minutes with prescribed single-limb non-invasive ventilation</description>
      <arm_group_label>Single-limb non-invasive ventilation</arm_group_label>
      <other_name>RT077</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Conventional full-face mask - dual-limb</intervention_name>
      <description>With cross-over in randomized order, conventional mask such as RT076, worn for 30 minutes with prescribed dual-limb non-invasive ventilation</description>
      <arm_group_label>Dual-limb non-invasive ventilation</arm_group_label>
      <other_name>RT076</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  No indication of intubation upon evaluation by physician in the next 2 hours&#xD;
  &#xD;
            -  Fits the investigational mask&#xD;
  &#xD;
          Specific for hypercapnic patients 1 of the following criteria&#xD;
  &#xD;
            -  Patients hospitalized with acute respiratory failure (ARF) stabilized and tolerating&#xD;
               NIV or;&#xD;
  &#xD;
            -  Patient admitted to hospital with ARF with one criteria for NIV among the following:&#xD;
  &#xD;
                 -  Acute hypercapnic respiratory failure with hypercapnia and acidosis (Partial&#xD;
                    pressure of arterial carbon dioxide (PaCO2) &gt; 45 millimeters of mercury (mmHg)&#xD;
                    and pH &lt; 7.38) or&#xD;
  &#xD;
                 -  Post-extubation period within 48 hours, in patients with high risk of&#xD;
                    re-intubation&#xD;
  &#xD;
          Specific for hypoxemic patients&#xD;
  &#xD;
          1 of the following criteria&#xD;
  &#xD;
            -  Hypoxemic respiratory failure without hypercapnia requiring nasal high flow or;&#xD;
  &#xD;
            -  Hypoxemic respiratory failure without hypercapnia requiring NIV or;&#xD;
  &#xD;
            -  Conventional oxygen therapy (COT) &gt; 6 liters per minute (L/min) with peripheral oxygen&#xD;
               saturation (SpO2) &lt; 92%&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Refusal to participate in the study&#xD;
  &#xD;
            -  Inability to provide informed consent&#xD;
  &#xD;
            -  Infectious isolation&#xD;
  &#xD;
            -  Facial deformity, burns or morphology that prevents adequate mask placement&#xD;
  &#xD;
            -  Claustrophobia&#xD;
  &#xD;
            -  Nausea&#xD;
  &#xD;
            -  Presence of nasogastric tube&#xD;
  &#xD;
            -  Pneumothorax&#xD;
  &#xD;
            -  Confusion or loss of consciousness&#xD;
  &#xD;
            -  Severe upper gastro-intestinal bleeding&#xD;
  &#xD;
            -  Any other condition, which at the investigators discretion, is believed may present a&#xD;
               safety risk or impact the feasibility of the study or study results&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Non-invasive Ventilation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Respiratory Insufficiency</mesh_term>
    </condition_browse>
    <!-- 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/NCT06007495
  org study id: CIP_336
  nct id: NCT06007495
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this pilot randomized cross-over study is to compare the effect of a full-face
        mask with expiratory washout to a conventional full face mask on non-invasive ventilation
        (NIV) in patients with acute hypercapnic, and acute hypoxemic, respiratory failure. The main
        questions it aims to answer are:
  
          -  Does a mask with expiratory washout improve minute ventilation in patients using
             non-invasive ventilation compared with a conventional single-limb NIV mask
  
          -  How does a mask with expiratory washout affect respiratory variables compared with a
             dual-limb NIV mask.
  
        Participants already prescribed NIV will undergo 3 arms of the investigation in a randomized
        order:
  
          -  Single-limb NIV with investigation mask (with expiratory washout)
  
          -  Single-limb NIV with conventional mask
  
          -  Dual-limb NIV with conventional mask
  The investigational mask has been designed to deliver non-invasive ventilation (NIV) therapy
        with expiratory washout.
  
        Expiratory washout is a technique designed to flush the upper airway of carbon dioxide at the
        end of expiration. During conventional NIV the gas at end of exhalation contributes to the
        functional dead space and "wasted" ventilation. The primary purpose of expiratory washout is
        to flush the upper airway with fresh gas during exhalation so the next supported breath which
        drives gas back into the alveolar regions has reduced carbon dioxide.
  
        Patients that are admitted to hospital with acute (hypercapnic or hypoxemic) respiratory
        failure, as assessed by normal hospital protocols, and starting or prescribed to start NIV
        therapy will be considered for the investigation. Once stabilized on NIV by the physician in
        charge of their care, eligible patients will be assessed against the inclusion/exclusion
        criteria and enrolled into the study if applicable.
  
        Participants that are enrolled into the study will be put onto oxygen therapy via nasal
        cannula for 15 minutes, during which time baseline measurements of physiological parameters
        (such as respiratory rate, tidal volume, minute ventilation and blood gases) and dyspnea
        scores will be recorded.
  
        Following baseline measurements, 32 participants will be randomized into one of the 3
        investigational arms and receive NIV with heated humidification according to the
        randomization protocol for 30 minutes each arm (90 minutes total). The same measurements will
        be recorded at the end of each 30-minute investigational arm. Participants will cross over to
        the other 2 conditions consecutively in a random order, each for 30 minutes.
  
        The ventilator settings (press support ventilation (PSV), positive end expiratory pressure
        (PEEP)) will be the following: PSV for tidal volume comprised between 6 and 8 millilitres per
        kilogram (ml/kg) predicted body weight (PBW), a titration period will be planned at the
        beginning of the first study period to target a tidal volume of 7 +/-1 ml/kg PBW and the PSV
        level will be kept constant thereafter. PEEP will be set according to the physician in charge
        (between 5 and 10 centimetres of water (cmH2O)) if NIV was used before inclusion or will be
        set by the investigators between 5 and 10 cmH2O. The fraction of inspired oxygen will be
        titrated manually to target peripheral saturation of oxygen of 88-92% in patients with
        hypercapnia and 90-94% in patients without hypercapnia.
  
        Once the investigation is complete, and participants have successfully finished all 3 arms of
        NIV therapy, the standard NIV protocols as per local hospital will resume, and participants
        will return to the care of their usual physician.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: Randomized Cross-Over study
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Minute Ventilation
  time frame: Recorded at baseline and the end of each 30-minute period of non-invasive ventilation over 1 hour and 30 minutes of data measurement
  description: Variations of the minute ventilation in the three different arms (Investigational mask, single-limb conventional, dual-limb conventional)
  measure: Tidal Volume
  time frame: Recorded at baseline and the end of each 30-minute period of non-invasive ventilation over 1 hour and 30 minutes of data measurement
  description: Changes in tidal volume over the three different arms
  measure: Respiratory Rate
  time frame: Recorded at baseline and the end of each 30-minute period of non-invasive ventilation over 1 hour and 30 minutes of data measurement
  description: Changes in respiratory rate over the three different arms
  measure: Blood gases
  time frame: Recorded at baseline and the end of each 30-minute period of non-invasive ventilation over 1 hour and 30 minutes of data measurement
  description: Changes in blood gas values over the three different arms
  measure: Dyspnoea Score
  time frame: Recorded at baseline and the end of each 30-minute period of non-invasive ventilation over 1 hour and 30 minutes of data measurement
  description: Changes in dyspnea score over the three different arms. Dyspnea measured with the modified Borg dyspnea score, which utilizes a scale of 0 to 10 where 0 represents no dyspnea and 10 represents maximal dyspnea.
  measure: Mask Comfort Score
  time frame: Recorded at baseline and the end of each 30-minute period of non-invasive ventilation over 1 hour and 30 minutes of data measurement
  description: Changes in mask comfort score over the three different arms. Mask comfort will be measured with a subjective likert scale of comfort where 1 represents maximal comfort, and 5 represents least comfort.
  arm group label: Single-limb non-invasive ventilation with expiratory washout
  arm group type: Experimental
  description: In a random order, 30 minute period of non-invasive ventilation using the investigational mask, a vented full-face mask with expiratory washout
  arm group label: Single-limb non-invasive ventilation
  arm group type: Active Comparator
  description: In a random order, 30 minute period of non-invasive ventilation with a conventional vented full-face mask (RT077 or equivalent)
  arm group label: Dual-limb non-invasive ventilation
  arm group type: Active Comparator
  description: In a random order, 30 minute period of non-invasive ventilation with a conventional vented full-face mask (RT076 or equivalent)
  intervention type: Device
  intervention name: Investigational full-face mask with expiratory washout
  description: With cross-over in randomized order, mask worn for 30 minutes with prescribed single-limb non-invasive ventilation
  arm group label: Single-limb non-invasive ventilation with expiratory washout
  intervention type: Device
  intervention name: Conventional full-face mask - single-limb
  description: With cross-over in randomized order, conventional mask such as RT077, worn for 30 minutes with prescribed single-limb non-invasive ventilation
  arm group label: Single-limb non-invasive ventilation
  other name: RT077
  intervention type: Device
  intervention name: Conventional full-face mask - dual-limb
  description: With cross-over in randomized order, conventional mask such as RT076, worn for 30 minutes with prescribed dual-limb non-invasive ventilation
  arm group label: Dual-limb non-invasive ventilation
  other name: RT076
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Respiratory Insufficiency