<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/NCT03759457</url>
  </required_header>
  <id_info>
    <org_study_id>Iperpneumo</org_study_id>
    <nct_id>NCT03759457</nct_id>
  </id_info>
  <brief_title>High Flow Nasal Cannula and Hypercapnia</brief_title>
  <official_title>High Flow Nasal Cannula (HFNC) in COPD Patients With Persistent Hypercapnia After an Acute Exacerbation</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>Yes</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 the present investigation, in 50 COPD with persistent hypercapnia after an acute&#xD;
      exacerbation, the investigators want to assess the acceptability of HFNC and its&#xD;
      effectiveness in further reducing the level of PaCO2, and to eventually verify the&#xD;
      hypothesis, based on previous physiological studies, that the response to HFNC is dependent&#xD;
      on the level of baseline hypercapnia and eventually on the presence of overlap syndrome. This&#xD;
      latter parameters to eventually calculate the sample size and the target population to&#xD;
      perform future definitive randomized long term trials vs NIV.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fifthy COPD patients inpatients recovering from an acute exacerbation of their disease and&#xD;
      persisting hypercapnia, despite having reached a stabilization in pH (i.e. pH&gt;7,35 and&#xD;
      PaCO2&gt;45 mmHg on 3 consecutive measurements) will be enrolled in the study after having&#xD;
      signed a written informed consent OSA/COPD overlap syndrome was not considered and exclusion&#xD;
      criteria and is defined as the presence of 15 or more obstructive respiratory events per hour&#xD;
      of sleep, when a previous full night polysomnography (PSG) was available or from a positive&#xD;
      Epworth questionnaire and a Body Mass Index&gt;25 Cardiac decompensation, restrictive thoracic&#xD;
      disorders, renal insufficiency, cancer, and neurological disease were considered exclusion&#xD;
      criteria.&#xD;
&#xD;
      On day the patients will undergo a preliminary trial with HFNC to set the optimal flow, using&#xD;
      the AIRVO2 (Fisher &amp; Paykel Healthcare, Auckland, New Zealand). To this aim the patients will&#xD;
      be asked to breathe keeping their mouth closed, as much as they could, at different levels of&#xD;
      flow, starting from 20 L/min up to 40 if tolerated for a minimum of 15 minutes for each&#xD;
      trial. At the end of this test the maximum level tolerated will be chosen as the flow to be&#xD;
      set for the experimental procedure. Temperature will be set according to the patient's&#xD;
      tolerance starting from 34C, up to 37C, while FiO2 will be kept constant to maintain an SaO2&#xD;
      between 92 and 94%.&#xD;
&#xD;
      From 9 am of day 2 to 9 am of day 5 (72 hours period), the patients will undergo HFNC for at&#xD;
      least 8 hours/day and during the nightime. The nurse on shift will be in charge of&#xD;
      supervising the adherence to this schedule and to report any violation of the protocol on a&#xD;
      dedicated sheet. Every morning at 10 am (1 hour after HFNC suspension) Arterial Blood Gases&#xD;
      (ABGs), effective hours of HFT and tolerance to the treatment as reported by the patient,&#xD;
      using a dedicated scale where: )1. Very bad 2. Bad 3. Moderate 4. Good 5.very good) will be&#xD;
      recorded&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 29, 2018</start_date>
  <completion_date type="Anticipated">January 29, 2019</completion_date>
  <primary_completion_date type="Anticipated">January 29, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group 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>immediately after intervention</time_frame>
    <description>Arterial Blood Gases, namely arterial oxygen (PaO2) and carbon dioxyde (PaCO2) tension will be analyzed from a sample taken from the arterial artery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>tolerance to the treatment</measure>
    <time_frame>immediately after intervention</time_frame>
    <description>this will be assessed using a standardized 4 points scale where tolerance to the treatment as reported by the patient, where categorized as: )1. Very bad 2. Bad 3. Moderate 4. Good 5.very good</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>High Flow Nasal Cannula</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High Flow Nasal Cannula is a relatively new technique able to deliver both oxygen and high flow in order to improve oxygenation and waking out CO2 from the upper airways</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>High Flow Nasal Cannula (AIRVO2)</intervention_name>
    <description>High-flow nasal cannula (HFNC) delivers oxygen flows of up to 60 L/min. The gas source (air/oxygen blender, ventilator, or turbine flow-generator) is connected via an active heated humidifier to a nasal cannula and allows FiO2 adjustment independently from the flow</description>
    <arm_group_label>High Flow Nasal Cannula</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  inpatients recovering from an acute exacerbation of their disease&#xD;
&#xD;
          -  persisting hypercapnia, despite having reached a stabilization in pH (i.e. pH&gt;7,35 and&#xD;
             PaCO2&gt;45 mmHg on 3 consecutive measurements)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiac decompensation,&#xD;
&#xD;
          -  restrictive thoracic disorders,&#xD;
&#xD;
          -  renal insufficiency,&#xD;
&#xD;
          -  cancer,&#xD;
&#xD;
          -  neurological disease&#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>IRCCS Azienda Ospedaliero-Universitaria di Bologna</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>lara pisani, md</last_name>
    <phone>390516363253</phone>
    <email>lara.pisani@aosp.bo.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sant'Orsola Hospital</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stefano Nava, md</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>November 29, 2018</last_update_submitted>
  <last_update_submitted_qc>November 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 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 the Respiratory nad Critical Care Unit</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypercapnia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>cannot release data prior to the termination of the study</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/NCT03759457
org study id: Iperpneumo
nct id: NCT03759457
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In the present investigation, in 50 COPD with persistent hypercapnia after an acute
      exacerbation, the investigators want to assess the acceptability of HFNC and its
      effectiveness in further reducing the level of PaCO2, and to eventually verify the
      hypothesis, based on previous physiological studies, that the response to HFNC is dependent
      on the level of baseline hypercapnia and eventually on the presence of overlap syndrome. This
      latter parameters to eventually calculate the sample size and the target population to
      perform future definitive randomized long term trials vs NIV.
Fifthy COPD patients inpatients recovering from an acute exacerbation of their disease and
      persisting hypercapnia, despite having reached a stabilization in pH (i.e. pH>7,35 and
      PaCO2>45 mmHg on 3 consecutive measurements) will be enrolled in the study after having
      signed a written informed consent OSA/COPD overlap syndrome was not considered and exclusion
      criteria and is defined as the presence of 15 or more obstructive respiratory events per hour
      of sleep, when a previous full night polysomnography (PSG) was available or from a positive
      Epworth questionnaire and a Body Mass Index>25 Cardiac decompensation, restrictive thoracic
      disorders, renal insufficiency, cancer, and neurological disease were considered exclusion
      criteria.

      On day the patients will undergo a preliminary trial with HFNC to set the optimal flow, using
      the AIRVO2 (Fisher & Paykel Healthcare, Auckland, New Zealand). To this aim the patients will
      be asked to breathe keeping their mouth closed, as much as they could, at different levels of
      flow, starting from 20 L/min up to 40 if tolerated for a minimum of 15 minutes for each
      trial. At the end of this test the maximum level tolerated will be chosen as the flow to be
      set for the experimental procedure. Temperature will be set according to the patient's
      tolerance starting from 34C, up to 37C, while FiO2 will be kept constant to maintain an SaO2
      between 92 and 94%.

      From 9 am of day 2 to 9 am of day 5 (72 hours period), the patients will undergo HFNC for at
      least 8 hours/day and during the nightime. The nurse on shift will be in charge of
      supervising the adherence to this schedule and to report any violation of the protocol on a
      dedicated sheet. Every morning at 10 am (1 hour after HFNC suspension) Arterial Blood Gases
      (ABGs), effective hours of HFT and tolerance to the treatment as reported by the patient,
      using a dedicated scale where: )1. Very bad 2. Bad 3. Moderate 4. Good 5.very good) will be
      recorded
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: changes in Arterial Blood Gases (ABGs)
time frame: immediately after intervention
description: Arterial Blood Gases, namely arterial oxygen (PaO2) and carbon dioxyde (PaCO2) tension will be analyzed from a sample taken from the arterial artery
measure: tolerance to the treatment
time frame: immediately after intervention
description: this will be assessed using a standardized 4 points scale where tolerance to the treatment as reported by the patient, where categorized as: )1. Very bad 2. Bad 3. Moderate 4. Good 5.very good
arm group label: High Flow Nasal Cannula
arm group type: Experimental
description: High Flow Nasal Cannula is a relatively new technique able to deliver both oxygen and high flow in order to improve oxygenation and waking out CO2 from the upper airways
intervention type: Device
intervention name: High Flow Nasal Cannula (AIRVO2)
description: High-flow nasal cannula (HFNC) delivers oxygen flows of up to 60 L/min. The gas source (air/oxygen blender, ventilator, or turbine flow-generator) is connected via an active heated humidifier to a nasal cannula and allows FiO2 adjustment independently from the flow
arm group label: High Flow Nasal Cannula
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: stefano nava
role: Principal Investigator
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
last name: lara pisani, md
phone: 390516363253
email: lara.pisani@aosp.bo.it
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
investigator full name: dr. Stefano Nava
investigator title: Chief of the Respiratory nad Critical Care Unit
mesh term: Hypercapnia
sharing ipd: No
ipd description: cannot release data prior to the termination of the study