<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/NCT03756415</url>
  </required_header>
  <id_info>
    <org_study_id>Stefano Nava1</org_study_id>
    <nct_id>NCT03756415</nct_id>
  </id_info>
  <brief_title>CO2 Clearance During Noninvasive Ventilation (NIV)</brief_title>
  <official_title>Evaluation of a New System to Clear CO2 During Noninvasive Ventilation (NIV)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS Azienda Ospedaliero-Universitaria di Bologna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS Azienda Ospedaliero-Universitaria di Bologna</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>
      In this randomized cross over study the investigators will evaluate the effects on gas&#xD;
      exchange and patients' tolerance of a new CO2 non rebreathing devices incorporated in the&#xD;
      mask vs the traditional mask COPD patients undergoing NIV for an episode of Acute Hypercapnia&#xD;
      Respiratory Failure, will be randomized after at least 12 hour of ventilation to 1 h.trial&#xD;
      with the usual full face mask or the same mask with the addition of a new CO2 clearance&#xD;
      device&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this randomized cross over study the investigators will evaluate the effects on gas&#xD;
      exchange and patients' tolerance of a new CO2 non rebreathing devices incorporated in the&#xD;
      mask vs the traditional mask COPD patients undergoing NIV for an episode of Acute Hypercapnia&#xD;
      Respiratory Failure, will be randomized after at least 12 hour of ventilation to 1 h.trial&#xD;
      with the usual full face mask (FM) or the same mask with the addition of a new CO2 clearance&#xD;
      device (FM+d) In the interval between NIV sessions, arterial blood gases will be monitored&#xD;
      and if PaCO2 will return to a baseline value with a tolerance of 10%, the patients will&#xD;
      undergo another 1 h trial using the other mask.&#xD;
&#xD;
      The subjects will be studied in the sitting position and asked to relax throughout the period&#xD;
      of the study.&#xD;
&#xD;
      The patients will be ventilated using pressure support ventilation (PSV) The order of use of&#xD;
      the two interfaces will be determined for each patient by a previously generated randomized&#xD;
      sequence.&#xD;
&#xD;
      FIO2 will be adjusted to obtain oxygen saturation around 92% at baseline and never modified&#xD;
      throughout the study.&#xD;
&#xD;
      End-expiratory pressure will always fixed at 2 cm H2O, and trigger sensitivity will set at&#xD;
      -0.5 cm H2O.&#xD;
&#xD;
      Inspiratory assistance during either PSV will be titrated to achieve a tidal volume between&#xD;
      6-8 mL/kg while avoiding occurrence of discomfort or visually assessed &quot;wasted efforts&quot;.&#xD;
&#xD;
      The ventilatory settings will determined at the beginning of the first trial, and maintained&#xD;
      unmodified throughout all the 3 runs.&#xD;
&#xD;
      Patient tolerance to NIMV, defined as the level of comfort using the different mask, will be&#xD;
      assessed by means of a scale used and validated in previous studies that is defined as&#xD;
      follows: 1, bad; 2, poor; 3, sufficient; 4, good; 5, very good. The patients were asked by&#xD;
      the respiratory therapist to answer the following question: &quot;How do the patient feel your&#xD;
      breathing is using this mask?&quot; The patient will give the score to the therapist at the end of&#xD;
      each run, just before ABG measurements.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2019</start_date>
  <completion_date type="Anticipated">June 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2019</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>changes in arterial blood gases (ABGs)</measure>
    <time_frame>immediate</time_frame>
    <description>Recording of carbon dioxide arterial tensione and oxygen arterial tension using an arterial puncture performed in the radial artery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>patient's tolerance to the mask</measure>
    <time_frame>immediate</time_frame>
    <description>the tolerance will be recorded using an ad hoc scale</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Acute Hypercapnic Respiratory Failure</condition>
  <arm_group>
    <arm_group_label>mask plus CO2 removal device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>a &quot;traditional&quot; mask with inserted a new CO2 removal device that is called DiMax Zero Total face mask &quot;R&quot;,</description>
  </arm_group>
  <arm_group>
    <arm_group_label>traditional face mask</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Traditional mask without a CO2 clearance device inserted</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DiMax Zero Total face mask &quot;R&quot;,</intervention_name>
    <description>a non-CO2 rebreathing device included directly in the full face mask</description>
    <arm_group_label>mask plus CO2 removal device</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>traditional face mask</intervention_name>
    <description>a traditional mask without a non-CO2 rebreathing device included directly in the full face mask</description>
    <arm_group_label>traditional face mask</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COPD diagnosis&#xD;
&#xD;
          -  sign inform consent&#xD;
&#xD;
          -  able to tolerate the application of NIV&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  inability to tolerate the mask&#xD;
&#xD;
          -  contraindication to NIV&#xD;
&#xD;
          -  cancer, neurological diseases, and need of another life support besides the ventilator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>stefano nava</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Ospedaliera Sant'Orsola</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>stefano nava</last_name>
    <phone>3333751828</phone>
    <email>stefanava@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>vittoria comellini</last_name>
    <email>vittoria.comellini@aosp.bo.it</email>
  </overall_contact_backup>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>November 26, 2018</last_update_submitted>
  <last_update_submitted_qc>November 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS Azienda Ospedaliero-Universitaria di Bologna</investigator_affiliation>
    <investigator_full_name>dr. Stefano Nava</investigator_full_name>
    <investigator_title>Chief of Pulmonary and Critical Care</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>not allow to release individual data</ipd_description>
  </patient_data>
  <!-- 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/NCT03756415
org study id: Stefano Nava1
nct id: NCT03756415
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this randomized cross over study the investigators will evaluate the effects on gas
      exchange and patients' tolerance of a new CO2 non rebreathing devices incorporated in the
      mask vs the traditional mask COPD patients undergoing NIV for an episode of Acute Hypercapnia
      Respiratory Failure, will be randomized after at least 12 hour of ventilation to 1 h.trial
      with the usual full face mask or the same mask with the addition of a new CO2 clearance
      device
In this randomized cross over study the investigators will evaluate the effects on gas
      exchange and patients' tolerance of a new CO2 non rebreathing devices incorporated in the
      mask vs the traditional mask COPD patients undergoing NIV for an episode of Acute Hypercapnia
      Respiratory Failure, will be randomized after at least 12 hour of ventilation to 1 h.trial
      with the usual full face mask (FM) or the same mask with the addition of a new CO2 clearance
      device (FM+d) In the interval between NIV sessions, arterial blood gases will be monitored
      and if PaCO2 will return to a baseline value with a tolerance of 10%, the patients will
      undergo another 1 h trial using the other mask.

      The subjects will be studied in the sitting position and asked to relax throughout the period
      of the study.

      The patients will be ventilated using pressure support ventilation (PSV) The order of use of
      the two interfaces will be determined for each patient by a previously generated randomized
      sequence.

      FIO2 will be adjusted to obtain oxygen saturation around 92% at baseline and never modified
      throughout the study.

      End-expiratory pressure will always fixed at 2 cm H2O, and trigger sensitivity will set at
      -0.5 cm H2O.

      Inspiratory assistance during either PSV will be titrated to achieve a tidal volume between
      6-8 mL/kg while avoiding occurrence of discomfort or visually assessed "wasted efforts".

      The ventilatory settings will determined at the beginning of the first trial, and maintained
      unmodified throughout all the 3 runs.

      Patient tolerance to NIMV, defined as the level of comfort using the different mask, will be
      assessed by means of a scale used and validated in previous studies that is defined as
      follows: 1, bad; 2, poor; 3, sufficient; 4, good; 5, very good. The patients were asked by
      the respiratory therapist to answer the following question: "How do the patient feel your
      breathing is using this mask?" The patient will give the score to the therapist at the end of
      each run, just before ABG measurements.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: changes in arterial blood gases (ABGs)
time frame: immediate
description: Recording of carbon dioxide arterial tensione and oxygen arterial tension using an arterial puncture performed in the radial artery
measure: patient's tolerance to the mask
time frame: immediate
description: the tolerance will be recorded using an ad hoc scale
arm group label: mask plus CO2 removal device
arm group type: Experimental
description: a "traditional" mask with inserted a new CO2 removal device that is called DiMax Zero Total face mask "R",
arm group label: traditional face mask
arm group type: Active Comparator
description: Traditional mask without a CO2 clearance device inserted
intervention type: Device
intervention name: DiMax Zero Total face mask "R",
description: a non-CO2 rebreathing device included directly in the full face mask
arm group label: mask plus CO2 removal device
intervention type: Device
intervention name: traditional face mask
description: a traditional mask without a non-CO2 rebreathing device included directly in the full face mask
arm group label: traditional face mask
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: stefano nava
role: Principal Investigator
affiliation: Azienda Ospedaliera Sant'Orsola
last name: stefano nava
phone: 3333751828
email: stefanava@gmail.com
last name: vittoria comellini
email: vittoria.comellini@aosp.bo.it
responsible party type: Principal Investigator
investigator affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
investigator full name: dr. Stefano Nava
investigator title: Chief of Pulmonary and Critical Care
mesh term: Respiratory Insufficiency
sharing ipd: No
ipd description: not allow to release individual data