<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/NCT03772626</url>
  </required_header>
  <id_info>
    <org_study_id>Heated Humidity after COPDE</org_study_id>
    <nct_id>NCT03772626</nct_id>
  </id_info>
  <brief_title>Heated High Humidity After COPD Exacerbation</brief_title>
  <official_title>The Feasibility and Efficacy of Heated Humidified Nasal Cannula (AIRVOTM) in Hospital and at Home - An Open-Label, Non-Randomized Pilot Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fisher and Paykel Healthcare</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>McMaster University</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>
      Chronic obstructive pulmonary disease (COPD) is a chronic lung disease usually caused by&#xD;
      exposure to tobacco smoke which leads to chronic symptoms of shortness of breath, cough, and&#xD;
      phlegm. COPD is one of the leading causes of disability and death in Canada. Individuals with&#xD;
      COPD often have periodic worsening of their disease, called exacerbations, consisting of&#xD;
      increased shortness of breath and often an increase in cough and phlegm. These exacerbations&#xD;
      often lead to hospital admission and are associated with worsening symptoms and lung function&#xD;
      over time. After an exacerbation individuals with COPD usually take several weeks to return&#xD;
      to their previous state of health and many people with an exacerbation who are discharged&#xD;
      from hospital return to the ER within 60. Heated humidified air has been shown to improve the&#xD;
      clearance of mucous in the lungs for people with chronic lung disease. By providing patients&#xD;
      at St. Joseph's Hospital who are discharged after a COPD exacerbation with a device for&#xD;
      delivering heated high humidity air to use overnight it is hoped that these individuals will&#xD;
      be able to more easily keep their lungs and airways free of mucous. This in turn may lead to&#xD;
      improvement in their symptoms of shortness of breath, cough, and phlegm production as well as&#xD;
      decreasing obstruction of the airways to reduce the risk of having to return to the emergency&#xD;
      room or hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      COPD is a respiratory condition that is often associated with cigarette smoking, and defined&#xD;
      by incompletely reversible airflow obstruction and complicated by exacerbations. Mucous&#xD;
      hypersecretion with impaired mucociliary transport are frequently present, and are associated&#xD;
      with infective AECOPD, and death related to pulmonary infection. COPD is both common,&#xD;
      affecting 1 in 6 Canadians, and burdensome, being the 4th leading cause of death, in the&#xD;
      Canadian population.&#xD;
&#xD;
      In Canada, the most common primary diagnosis associated with admission to hospital is acute&#xD;
      exacerbation of COPD (AECOPD). For moderate to severe COPD, the average patient will have&#xD;
      more than 2 AECOPD per year. A single episode conveys a poor prognosis, being associated with&#xD;
      death, further AECOPD events, and reduced health-related quality of life. Despite multiple&#xD;
      guideline-based management strategies, 1 in 3 patients with AECOPD will have another episode&#xD;
      within 8 weeks.&#xD;
&#xD;
      Although the technology for heated humidified high-flow nasal cannula (HFNC) has been&#xD;
      available for two decades, it has only recently become widely available for adults. The rapid&#xD;
      humidification of gas allows this system to achieve flow rates of up to 60 liters per minute.&#xD;
      These two factors, in combination, allow for a higher achieved fraction of inspired oxygen,&#xD;
      and benefit the expectoration of secretions and ventilatory efficiency. Randomised clinical&#xD;
      trials of ICU patients have demonstrated that HFNC is non-inferior to non-invasive&#xD;
      ventilation both in the setting of acute hypoxemic respiratory failure and as an adjunct&#xD;
      therapy post-extubation.&#xD;
&#xD;
      HFNC is a promising treatment for patients with COPD as it can counteract potentially harmful&#xD;
      mucous abnormalities by reducing mucous viscosity and restoring mucociliary transport.&#xD;
      Randomised studies have also demonstrated that HFNC administered at home results in an&#xD;
      increased the time to first exacerbation, fewer AECOPD, improved quality-of-life, and reduced&#xD;
      PaCO2. However, the efficacy of HFNC during hospital admission, when mucous abnormalities and&#xD;
      poor expectoration could be most pronounced, has not yet been studied. Furthermore, the&#xD;
      feasibility and efficacy of this device as a patient transitions from the hospital to the&#xD;
      community after an AECOPD remains to be elucidated.&#xD;
&#xD;
      The objectives of this study are to test the efficacy of a heated humidified high-flow nasal&#xD;
      cannula used during and after a hospital admission for AECOPD to reduce the risk of return to&#xD;
      ER or readmission, and the feasibility of implementing such a device starting in hospital&#xD;
      with transition to the home environment.&#xD;
&#xD;
      This is an open-label, non-randomized pilot study of in-hospital and home HFNC in patients&#xD;
      with COPD. Patients who consent to participate will have an a heated humidified high-flow&#xD;
      nasal cannula device configured by a respiratory therapist and available at their bedside in&#xD;
      hospital. Fraction of inspired oxygen will be adjusted as needed to obtain a pulse oximetry&#xD;
      reading between 88-92%. If hypoxemia is not present (peripheral oxygen saturation (SpO2)&#xD;
      ≥88%) on room air, then the device will be used without supplemental oxygen. Temperature and&#xD;
      flow rate will be titrated for patient comfort with a target temperature of 37 degrees&#xD;
      Celsius and flow rate of ≥20 liters per minute if tolerated. Participants will be instructed&#xD;
      to use the device overnight and as much as they like during the day targeting at least 6&#xD;
      hours of use per 24 hour period.&#xD;
&#xD;
      At discharge, subjects will be provided with a heated humidified high-flow nasal cannula home&#xD;
      device. Targeted use and oxygen titration will remain unchanged from inpatient use. A&#xD;
      respiratory therapist from will perform a home visit within 24 hours of hospital discharge to&#xD;
      educate the patient on home use and ensure proper set up of the device, and an additional&#xD;
      visit 2 weeks post-discharge. Patients will have access to a 24 hour emergency telephone&#xD;
      number if they have any concerns. The duration of the trial will be 60 days post-discharge&#xD;
      after which the device will be returned.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 25, 2019</start_date>
  <completion_date type="Anticipated">December 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2022</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>
    <intervention_model_description>Single group non-randomized open label study of efficacy and feasibility. Comparison will be to historical controls.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ER use or hospitalization for COPD</measure>
    <time_frame>Length of study participation (60 days after hospital discharge)</time_frame>
    <description>ER visits or hospital admissions for COPD during the 60 day treatment period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>Collected throughout inpatient enrollment period until last enrolled patient discharged (Expected total of 70 days)</time_frame>
    <description>Total length of stay in hospital during index admission for COPD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of home-care resources</measure>
    <time_frame>Length of study participation (60 days after hospital discharge)</time_frame>
    <description>Total number of unplanned home visits during study period</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Average daily use of heated humidified high-flow nasal cannula</measure>
    <time_frame>Length of study participation (60 days after hospital discharge)</time_frame>
    <description>number of hours of machine use divided by days enrolled in study</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of eligible patients who consent to the trial</measure>
    <time_frame>Collected throughout inpatient enrollment period (total of 60 days)</time_frame>
    <description>Proportion of eligible patients who consent will be calculated</description>
  </other_outcome>
  <other_outcome>
    <measure>Drop out rate</measure>
    <time_frame>Length of study participation (60 days after hospital discharge)</time_frame>
    <description>Proportion of patients who enroll in the trial who successfully complete the trial</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient satisfaction with heated humidified high-flow nasal cannula</measure>
    <time_frame>Collected at end of study participartion (60 days after hospital discharge)</time_frame>
    <description>brief survey created for the study to measure patient satisfaction with the device. 5 questions, each individual item will be rated on a 5 part Likert scale from 1 = strongly agree to 5 = strongly disagree with a 1 indicating the highest satisfaction and a 5 indicating the lowest satisfaction. Results for each question will be reported separately.</description>
  </other_outcome>
  <other_outcome>
    <measure>Nursing satisfaction with heated humidified high-flow nasal cannula in hospital</measure>
    <time_frame>Collected throughout inpatient enrollment period (total of 60 days)</time_frame>
    <description>Anonymous satisfaction survey given to nurses on medical units, brief survey created for the study to measure nursing satisfaction with the device. 5 questions, each individual item will be rated on a 5 part Likert scale from 1 = strongly agree to 5 = strongly disagree with a 1 indicating the highest satisfaction and a 5 indicating the lowest satisfaction. Results for each question will be reported separately.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>COPD Exacerbation</condition>
  <arm_group>
    <arm_group_label>Heated humidified high-flow</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Heated Humidified High-flow Nasal Cannula</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Heated Humidified High-flow Nasal Cannula</intervention_name>
    <description>Patients will receive heated high humidity air through the AIRVO(TM) device starting in hospital and continuing for 60 days after hospital discharge. Oxygen will be titrated to target SpO2 between 88-92%, patients not requiring oxygen will receive heated high humidity air without oxygen. Temperature and flow rate will titrated to patient comfort with a target temperature 37 degree Celsius and flow rate of ≥20 l/minute. Patients will be encouraged to use the device overnight and when needed during the day with a target duration of at least 6 hours per night</description>
    <arm_group_label>Heated humidified high-flow</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Admitted to Hospital with a primary diagnosis of exacerbation of COPD&#xD;
&#xD;
          -  Greater then or equal to 20 pack year history of smoking&#xD;
&#xD;
          -  Participating in Integrated Comprehensive Care (ICC) home care program&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Requirement for acute non-invasive ventilation in hospital&#xD;
&#xD;
          -  Use of nocturnal non-invasive ventilation prior to hospitalization&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joshua Wald, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McMaster University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Joseph's Healthcare Hamilton</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8N 4A6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>O'Donnell DE, Aaron S, Bourbeau J, Hernandez P, Marciniuk DD, Balter M, Ford G, Gervais A, Goldstein R, Hodder R, Kaplan A, Keenan S, Lacasse Y, Maltais F, Road J, Rocker G, Sin D, Sinuff T, Voduc N. Canadian Thoracic Society recommendations for management of chronic obstructive pulmonary disease - 2007 update. Can Respir J. 2007 Sep;14 Suppl B(Suppl B):5B-32B. doi: 10.1155/2007/830570.</citation>
    <PMID>17885691</PMID>
  </reference>
  <reference>
    <citation>Rogers DF. The role of airway secretions in COPD: pathophysiology, epidemiology and pharmacotherapeutic options. COPD. 2005 Sep;2(3):341-53. doi: 10.1080/15412550500218098.</citation>
    <PMID>17146999</PMID>
  </reference>
  <reference>
    <citation>Prescott E, Lange P, Vestbo J. Chronic mucus hypersecretion in COPD and death from pulmonary infection. Eur Respir J. 1995 Aug;8(8):1333-8. doi: 10.1183/09031936.95.08081333.</citation>
    <PMID>7489800</PMID>
  </reference>
  <reference>
    <citation>Gershon AS, Thiruchelvam D, Chapman KR, Aaron SD, Stanbrook MB, Bourbeau J, Tan W, To T; Canadian Respiratory Research Network. Health Services Burden of Undiagnosed and Overdiagnosed COPD. Chest. 2018 Jun;153(6):1336-1346. doi: 10.1016/j.chest.2018.01.038. Epub 2018 Feb 6.</citation>
    <PMID>29425675</PMID>
  </reference>
  <reference>
    <citation>O'Donnell DE, Hernandez P, Kaplan A, Aaron S, Bourbeau J, Marciniuk D, Balter M, Ford G, Gervais A, Lacasse Y, Maltais F, Road J, Rocker G, Sin D, Sinuff T, Voduc N. Canadian Thoracic Society recommendations for management of chronic obstructive pulmonary disease - 2008 update - highlights for primary care. Can Respir J. 2008 Jan-Feb;15 Suppl A(Suppl A):1A-8A. doi: 10.1155/2008/641965.</citation>
    <PMID>18292855</PMID>
  </reference>
  <reference>
    <citation>Keene JD, Jacobson S, Kechris K, Kinney GL, Foreman MG, Doerschuk CM, Make BJ, Curtis JL, Rennard SI, Barr RG, Bleecker ER, Kanner RE, Kleerup EC, Hansel NN, Woodruff PG, Han MK, Paine R 3rd, Martinez FJ, Bowler RP, O'Neal WK; COPDGene and SPIROMICS Investigators double dagger. Biomarkers Predictive of Exacerbations in the SPIROMICS and COPDGene Cohorts. Am J Respir Crit Care Med. 2017 Feb 15;195(4):473-481. doi: 10.1164/rccm.201607-1330OC.</citation>
    <PMID>27579823</PMID>
  </reference>
  <reference>
    <citation>Connors AF Jr, Dawson NV, Thomas C, Harrell FE Jr, Desbiens N, Fulkerson WJ, Kussin P, Bellamy P, Goldman L, Knaus WA. Outcomes following acute exacerbation of severe chronic obstructive lung disease. The SUPPORT investigators (Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments). Am J Respir Crit Care Med. 1996 Oct;154(4 Pt 1):959-67. doi: 10.1164/ajrccm.154.4.8887592. Erratum In: Am J Respir Crit Care Med 1997 Jan;155(1):386.</citation>
    <PMID>8887592</PMID>
  </reference>
  <reference>
    <citation>Groenewegen KH, Schols AM, Wouters EF. Mortality and mortality-related factors after hospitalization for acute exacerbation of COPD. Chest. 2003 Aug;124(2):459-67. doi: 10.1378/chest.124.2.459.</citation>
    <PMID>12907529</PMID>
  </reference>
  <reference>
    <citation>Pradan L, Ferreira I, Postolache P. The quality of medical care during an acute exacerbations of chronic obstructive pulmonary disease. Rev Med Chir Soc Med Nat Iasi. 2013 Oct-Dec;117(4):870-4.</citation>
    <PMID>24502063</PMID>
  </reference>
  <reference>
    <citation>Donaldson GC, Wedzicha JA. COPD exacerbations .1: Epidemiology. Thorax. 2006 Feb;61(2):164-8. doi: 10.1136/thx.2005.041806.</citation>
    <PMID>16443707</PMID>
  </reference>
  <reference>
    <citation>Spoletini G, Alotaibi M, Blasi F, Hill NS. Heated Humidified High-Flow Nasal Oxygen in Adults: Mechanisms of Action and Clinical Implications. Chest. 2015 Jul;148(1):253-261. doi: 10.1378/chest.14-2871.</citation>
    <PMID>25742321</PMID>
  </reference>
  <reference>
    <citation>Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.</citation>
    <PMID>25981908</PMID>
  </reference>
  <reference>
    <citation>Hernandez G, Vaquero C, Colinas L, Cuena R, Gonzalez P, Canabal A, Sanchez S, Rodriguez ML, Villasclaras A, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in High-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Oct 18;316(15):1565-1574. doi: 10.1001/jama.2016.14194. Erratum In: JAMA. 2016 Nov 15;316(19):2047-2048. JAMA. 2017 Feb 28;317(8):858.</citation>
    <PMID>27706464</PMID>
  </reference>
  <reference>
    <citation>Rea H, McAuley S, Jayaram L, Garrett J, Hockey H, Storey L, O'Donnell G, Haru L, Payton M, O'Donnell K. The clinical utility of long-term humidification therapy in chronic airway disease. Respir Med. 2010 Apr;104(4):525-33. doi: 10.1016/j.rmed.2009.12.016. Epub 2010 Feb 9.</citation>
    <PMID>20144858</PMID>
  </reference>
  <reference>
    <citation>Storgaard LH, Hockey HU, Laursen BS, Weinreich UM. Long-term effects of oxygen-enriched high-flow nasal cannula treatment in COPD patients with chronic hypoxemic respiratory failure. Int J Chron Obstruct Pulmon Dis. 2018 Apr 16;13:1195-1205. doi: 10.2147/COPD.S159666. eCollection 2018.</citation>
    <PMID>29713153</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>April 6, 2022</last_update_submitted>
  <last_update_submitted_qc>April 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McMaster University</investigator_affiliation>
    <investigator_full_name>Joshua Wald</investigator_full_name>
    <investigator_title>Assistant Professor Department of Medicine</investigator_title>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>Heated humidified high-flow nasal cannula</keyword>
  <keyword>Exacerbation of COPD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03772626
org study id: Heated Humidity after COPDE
nct id: NCT03772626
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Chronic obstructive pulmonary disease (COPD) is a chronic lung disease usually caused by
      exposure to tobacco smoke which leads to chronic symptoms of shortness of breath, cough, and
      phlegm. COPD is one of the leading causes of disability and death in Canada. Individuals with
      COPD often have periodic worsening of their disease, called exacerbations, consisting of
      increased shortness of breath and often an increase in cough and phlegm. These exacerbations
      often lead to hospital admission and are associated with worsening symptoms and lung function
      over time. After an exacerbation individuals with COPD usually take several weeks to return
      to their previous state of health and many people with an exacerbation who are discharged
      from hospital return to the ER within 60. Heated humidified air has been shown to improve the
      clearance of mucous in the lungs for people with chronic lung disease. By providing patients
      at St. Joseph's Hospital who are discharged after a COPD exacerbation with a device for
      delivering heated high humidity air to use overnight it is hoped that these individuals will
      be able to more easily keep their lungs and airways free of mucous. This in turn may lead to
      improvement in their symptoms of shortness of breath, cough, and phlegm production as well as
      decreasing obstruction of the airways to reduce the risk of having to return to the emergency
      room or hospital.
COPD is a respiratory condition that is often associated with cigarette smoking, and defined
      by incompletely reversible airflow obstruction and complicated by exacerbations. Mucous
      hypersecretion with impaired mucociliary transport are frequently present, and are associated
      with infective AECOPD, and death related to pulmonary infection. COPD is both common,
      affecting 1 in 6 Canadians, and burdensome, being the 4th leading cause of death, in the
      Canadian population.

      In Canada, the most common primary diagnosis associated with admission to hospital is acute
      exacerbation of COPD (AECOPD). For moderate to severe COPD, the average patient will have
      more than 2 AECOPD per year. A single episode conveys a poor prognosis, being associated with
      death, further AECOPD events, and reduced health-related quality of life. Despite multiple
      guideline-based management strategies, 1 in 3 patients with AECOPD will have another episode
      within 8 weeks.

      Although the technology for heated humidified high-flow nasal cannula (HFNC) has been
      available for two decades, it has only recently become widely available for adults. The rapid
      humidification of gas allows this system to achieve flow rates of up to 60 liters per minute.
      These two factors, in combination, allow for a higher achieved fraction of inspired oxygen,
      and benefit the expectoration of secretions and ventilatory efficiency. Randomised clinical
      trials of ICU patients have demonstrated that HFNC is non-inferior to non-invasive
      ventilation both in the setting of acute hypoxemic respiratory failure and as an adjunct
      therapy post-extubation.

      HFNC is a promising treatment for patients with COPD as it can counteract potentially harmful
      mucous abnormalities by reducing mucous viscosity and restoring mucociliary transport.
      Randomised studies have also demonstrated that HFNC administered at home results in an
      increased the time to first exacerbation, fewer AECOPD, improved quality-of-life, and reduced
      PaCO2. However, the efficacy of HFNC during hospital admission, when mucous abnormalities and
      poor expectoration could be most pronounced, has not yet been studied. Furthermore, the
      feasibility and efficacy of this device as a patient transitions from the hospital to the
      community after an AECOPD remains to be elucidated.

      The objectives of this study are to test the efficacy of a heated humidified high-flow nasal
      cannula used during and after a hospital admission for AECOPD to reduce the risk of return to
      ER or readmission, and the feasibility of implementing such a device starting in hospital
      with transition to the home environment.

      This is an open-label, non-randomized pilot study of in-hospital and home HFNC in patients
      with COPD. Patients who consent to participate will have an a heated humidified high-flow
      nasal cannula device configured by a respiratory therapist and available at their bedside in
      hospital. Fraction of inspired oxygen will be adjusted as needed to obtain a pulse oximetry
      reading between 88-92%. If hypoxemia is not present (peripheral oxygen saturation (SpO2)
      ≥88%) on room air, then the device will be used without supplemental oxygen. Temperature and
      flow rate will be titrated for patient comfort with a target temperature of 37 degrees
      Celsius and flow rate of ≥20 liters per minute if tolerated. Participants will be instructed
      to use the device overnight and as much as they like during the day targeting at least 6
      hours of use per 24 hour period.

      At discharge, subjects will be provided with a heated humidified high-flow nasal cannula home
      device. Targeted use and oxygen titration will remain unchanged from inpatient use. A
      respiratory therapist from will perform a home visit within 24 hours of hospital discharge to
      educate the patient on home use and ensure proper set up of the device, and an additional
      visit 2 weeks post-discharge. Patients will have access to a 24 hour emergency telephone
      number if they have any concerns. The duration of the trial will be 60 days post-discharge
      after which the device will be returned.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single group non-randomized open label study of efficacy and feasibility. Comparison will be to historical controls.
primary purpose: Treatment
masking: None (Open Label)
measure: ER use or hospitalization for COPD
time frame: Length of study participation (60 days after hospital discharge)
description: ER visits or hospital admissions for COPD during the 60 day treatment period
measure: Hospital length of stay
time frame: Collected throughout inpatient enrollment period until last enrolled patient discharged (Expected total of 70 days)
description: Total length of stay in hospital during index admission for COPD
measure: Use of home-care resources
time frame: Length of study participation (60 days after hospital discharge)
description: Total number of unplanned home visits during study period
measure: Average daily use of heated humidified high-flow nasal cannula
time frame: Length of study participation (60 days after hospital discharge)
description: number of hours of machine use divided by days enrolled in study
measure: Number of eligible patients who consent to the trial
time frame: Collected throughout inpatient enrollment period (total of 60 days)
description: Proportion of eligible patients who consent will be calculated
measure: Drop out rate
time frame: Length of study participation (60 days after hospital discharge)
description: Proportion of patients who enroll in the trial who successfully complete the trial
measure: Patient satisfaction with heated humidified high-flow nasal cannula
time frame: Collected at end of study participartion (60 days after hospital discharge)
description: brief survey created for the study to measure patient satisfaction with the device. 5 questions, each individual item will be rated on a 5 part Likert scale from 1 = strongly agree to 5 = strongly disagree with a 1 indicating the highest satisfaction and a 5 indicating the lowest satisfaction. Results for each question will be reported separately.
measure: Nursing satisfaction with heated humidified high-flow nasal cannula in hospital
time frame: Collected throughout inpatient enrollment period (total of 60 days)
description: Anonymous satisfaction survey given to nurses on medical units, brief survey created for the study to measure nursing satisfaction with the device. 5 questions, each individual item will be rated on a 5 part Likert scale from 1 = strongly agree to 5 = strongly disagree with a 1 indicating the highest satisfaction and a 5 indicating the lowest satisfaction. Results for each question will be reported separately.
arm group label: Heated humidified high-flow
arm group type: Experimental
description: Heated Humidified High-flow Nasal Cannula
intervention type: Device
intervention name: Heated Humidified High-flow Nasal Cannula
description: Patients will receive heated high humidity air through the AIRVO(TM) device starting in hospital and continuing for 60 days after hospital discharge. Oxygen will be titrated to target SpO2 between 88-92%, patients not requiring oxygen will receive heated high humidity air without oxygen. Temperature and flow rate will titrated to patient comfort with a target temperature 37 degree Celsius and flow rate of ≥20 l/minute. Patients will be encouraged to use the device overnight and when needed during the day with a target duration of at least 6 hours per night
arm group label: Heated humidified high-flow
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Joshua Wald, MD
role: Principal Investigator
affiliation: McMaster University
facility: 
country: Canada
citation: O'Donnell DE, Aaron S, Bourbeau J, Hernandez P, Marciniuk DD, Balter M, Ford G, Gervais A, Goldstein R, Hodder R, Kaplan A, Keenan S, Lacasse Y, Maltais F, Road J, Rocker G, Sin D, Sinuff T, Voduc N. Canadian Thoracic Society recommendations for management of chronic obstructive pulmonary disease - 2007 update. Can Respir J. 2007 Sep;14 Suppl B(Suppl B):5B-32B. doi: 10.1155/2007/830570.
PMID: 17885691
citation: Rogers DF. The role of airway secretions in COPD: pathophysiology, epidemiology and pharmacotherapeutic options. COPD. 2005 Sep;2(3):341-53. doi: 10.1080/15412550500218098.
PMID: 17146999
citation: Prescott E, Lange P, Vestbo J. Chronic mucus hypersecretion in COPD and death from pulmonary infection. Eur Respir J. 1995 Aug;8(8):1333-8. doi: 10.1183/09031936.95.08081333.
PMID: 7489800
citation: Gershon AS, Thiruchelvam D, Chapman KR, Aaron SD, Stanbrook MB, Bourbeau J, Tan W, To T; Canadian Respiratory Research Network. Health Services Burden of Undiagnosed and Overdiagnosed COPD. Chest. 2018 Jun;153(6):1336-1346. doi: 10.1016/j.chest.2018.01.038. Epub 2018 Feb 6.
PMID: 29425675
citation: O'Donnell DE, Hernandez P, Kaplan A, Aaron S, Bourbeau J, Marciniuk D, Balter M, Ford G, Gervais A, Lacasse Y, Maltais F, Road J, Rocker G, Sin D, Sinuff T, Voduc N. Canadian Thoracic Society recommendations for management of chronic obstructive pulmonary disease - 2008 update - highlights for primary care. Can Respir J. 2008 Jan-Feb;15 Suppl A(Suppl A):1A-8A. doi: 10.1155/2008/641965.
PMID: 18292855
citation: Keene JD, Jacobson S, Kechris K, Kinney GL, Foreman MG, Doerschuk CM, Make BJ, Curtis JL, Rennard SI, Barr RG, Bleecker ER, Kanner RE, Kleerup EC, Hansel NN, Woodruff PG, Han MK, Paine R 3rd, Martinez FJ, Bowler RP, O'Neal WK; COPDGene and SPIROMICS Investigators double dagger. Biomarkers Predictive of Exacerbations in the SPIROMICS and COPDGene Cohorts. Am J Respir Crit Care Med. 2017 Feb 15;195(4):473-481. doi: 10.1164/rccm.201607-1330OC.
PMID: 27579823
citation: Connors AF Jr, Dawson NV, Thomas C, Harrell FE Jr, Desbiens N, Fulkerson WJ, Kussin P, Bellamy P, Goldman L, Knaus WA. Outcomes following acute exacerbation of severe chronic obstructive lung disease. The SUPPORT investigators (Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments). Am J Respir Crit Care Med. 1996 Oct;154(4 Pt 1):959-67. doi: 10.1164/ajrccm.154.4.8887592. Erratum In: Am J Respir Crit Care Med 1997 Jan;155(1):386.
PMID: 8887592
citation: Groenewegen KH, Schols AM, Wouters EF. Mortality and mortality-related factors after hospitalization for acute exacerbation of COPD. Chest. 2003 Aug;124(2):459-67. doi: 10.1378/chest.124.2.459.
PMID: 12907529
citation: Pradan L, Ferreira I, Postolache P. The quality of medical care during an acute exacerbations of chronic obstructive pulmonary disease. Rev Med Chir Soc Med Nat Iasi. 2013 Oct-Dec;117(4):870-4.
PMID: 24502063
citation: Donaldson GC, Wedzicha JA. COPD exacerbations .1: Epidemiology. Thorax. 2006 Feb;61(2):164-8. doi: 10.1136/thx.2005.041806.
PMID: 16443707
citation: Spoletini G, Alotaibi M, Blasi F, Hill NS. Heated Humidified High-Flow Nasal Oxygen in Adults: Mechanisms of Action and Clinical Implications. Chest. 2015 Jul;148(1):253-261. doi: 10.1378/chest.14-2871.
PMID: 25742321
citation: Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.
PMID: 25981908
citation: Hernandez G, Vaquero C, Colinas L, Cuena R, Gonzalez P, Canabal A, Sanchez S, Rodriguez ML, Villasclaras A, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in High-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Oct 18;316(15):1565-1574. doi: 10.1001/jama.2016.14194. Erratum In: JAMA. 2016 Nov 15;316(19):2047-2048. JAMA. 2017 Feb 28;317(8):858.
PMID: 27706464
citation: Rea H, McAuley S, Jayaram L, Garrett J, Hockey H, Storey L, O'Donnell G, Haru L, Payton M, O'Donnell K. The clinical utility of long-term humidification therapy in chronic airway disease. Respir Med. 2010 Apr;104(4):525-33. doi: 10.1016/j.rmed.2009.12.016. Epub 2010 Feb 9.
PMID: 20144858
citation: Storgaard LH, Hockey HU, Laursen BS, Weinreich UM. Long-term effects of oxygen-enriched high-flow nasal cannula treatment in COPD patients with chronic hypoxemic respiratory failure. Int J Chron Obstruct Pulmon Dis. 2018 Apr 16;13:1195-1205. doi: 10.2147/COPD.S159666. eCollection 2018.
PMID: 29713153
responsible party type: Principal Investigator
investigator affiliation: McMaster University
investigator full name: Joshua Wald
investigator title: Assistant Professor Department of Medicine
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No