<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/NCT03811158</url>
  </required_header>
  <id_info>
    <org_study_id>PL-201705001-M</org_study_id>
    <nct_id>NCT03811158</nct_id>
  </id_info>
  <brief_title>The Edi Level and Cardiopulmonary Function Between HHHFNC and Unheated Humidified High-Flow Oxygen Mask in COPD</brief_title>
  <official_title>The Diaphragm Activity Level and Cardiopulmonary Function Between Heated Humidified High-Flow Nasal Cannula and Unheated Humidified High-Flow Oxygen Mask in Acute Exacerbation of COPD Patients as Post-Extubation Respiratory Support</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fu Jen Catholic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fu Jen Catholic 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with COPD exacerbation usually need respiratory support after extubation. Recently,&#xD;
      HHHFNC has been used in both adult and neonates with post-extubation respiratory support.&#xD;
      Studies indicate that HHHFNC has seminar efficacy compared to non-invasive positive pressure&#xD;
      ventilation and superior than conventional oxygen therapy. There are no clinical data of&#xD;
      diaphragm electrical activity and cardiopulmonary function for using HHHFNC and UHFOM as&#xD;
      post-extubation respiratory support.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives： The aim of this study is to compare the Edi level and cardiopulmonary parameters&#xD;
      between heated humidified high-flow nasal cannula (HHHFNC) versus unheated high-flow oxygen&#xD;
      mask (UHFOM) in acute exacerbation of chronic obstructive pulmonary disease (COPD) patients&#xD;
      with post-extubation respiratory support. This is the first clinical trial to investigate and&#xD;
      analysis the variations of cardiopulmonary parameters and Edi level between HHHFNC and UHFOM&#xD;
      in adult patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Difficult to recruit participants&#xD;
  </why_stopped>
  <start_date type="Actual">May 21, 2018</start_date>
  <completion_date type="Actual">July 31, 2022</completion_date>
  <primary_completion_date type="Actual">June 30, 2022</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>Patents with COPD exacerbation who were intubated for respiratory failure will all enrolled to this study. Participants will be studied on 2 consecutive days and random assigned with crossover. The primary outcome measure is the diaphragm electrical activity. The secondary outcome measures include the cardiopulmonary function, length of hospital stay, and re-intubation rate.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>All data will be decoded before biostatics analysis</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Diaphragm electrical activity</measure>
    <time_frame>2 days</time_frame>
    <description>In voltage</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PtcO2 &amp; PtcCO2</measure>
    <time_frame>2 days</time_frame>
    <description>In mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-intubation rate</measure>
    <time_frame>2 days</time_frame>
    <description>In %</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac index</measure>
    <time_frame>2 days</time_frame>
    <description>In L/min/m2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital stay</measure>
    <time_frame>through study completion, an average 3 months</time_frame>
    <description>In days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU stay</measure>
    <time_frame>through study completion, an average 1 months</time_frame>
    <description>In days</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Chronic Obstructive Lung Disease</condition>
  <condition>Respiratory Insufficiency</condition>
  <arm_group>
    <arm_group_label>HHHFNC group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>On HHHFNC FiO2 will setting as same as SBT before extubation Flow rate: 50L/min</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UHFOM group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>On Aerosol mask FiO2 will setting as same as SBT before extubation Flow rate: 15L/min</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HHHFNC</intervention_name>
    <description>Prospective, randomized crossover control trial, single ICU. Patents with COPD exacerbation who were intubated for respiratory failure will all enrolled to this study. Participants will be studied on 2 consecutive days and random assigned with crossover.</description>
    <arm_group_label>HHHFNC group</arm_group_label>
    <other_name>Study group</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>UHFOM</intervention_name>
    <description>Prospective, randomized crossover control trial, single ICU. Patents with COPD exacerbation who were intubated for respiratory failure will all enrolled to this study. Participants will be studied on 2 consecutive days and random assigned with crossover.</description>
    <arm_group_label>UHFOM group</arm_group_label>
    <other_name>Control group</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. AE of COPD received intubation and ready to be weaning&#xD;
&#xD;
          2. P/F ratio &gt; 200 during SBT before extubation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unable to insert NG tube&#xD;
&#xD;
          2. Refuse to re-intubated when respiratory failure after extubation&#xD;
&#xD;
          3. Planned NIV use after extubation&#xD;
&#xD;
          4. Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ke-Yun Chao, M.Sc</last_name>
    <role>Principal Investigator</role>
    <affiliation>ck_qq@hotmail.com</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fu Jen Catholic University Hospital, Fu Jen Catholic University</name>
      <address>
        <city>New Taipei City</city>
        <zip>24352</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <results_reference>
    <citation>Brotfain E, Zlotnik A, Schwartz A, Frenkel A, Koyfman L, Gruenbaum SE, Klein M. Comparison of the effectiveness of high flow nasal oxygen cannula vs. standard non-rebreather oxygen face mask in post-extubation intensive care unit patients. Isr Med Assoc J. 2014 Nov;16(11):718-22.</citation>
    <PMID>25558703</PMID>
  </results_reference>
  <results_reference>
    <citation>Stephan F, Barrucand B, Petit P, Rezaiguia-Delclaux S, Medard A, Delannoy B, Cosserant B, Flicoteaux G, Imbert A, Pilorge C, Berard L; BiPOP Study Group. High-Flow Nasal Oxygen vs Noninvasive Positive Airway Pressure in Hypoxemic Patients After Cardiothoracic Surgery: A Randomized Clinical Trial. JAMA. 2015 Jun 16;313(23):2331-9. doi: 10.1001/jama.2015.5213.</citation>
    <PMID>25980660</PMID>
  </results_reference>
  <results_reference>
    <citation>Futier E, Paugam-Burtz C, Godet T, Khoy-Ear L, Rozencwajg S, Delay JM, Verzilli D, Dupuis J, Chanques G, Bazin JE, Constantin JM, Pereira B, Jaber S; OPERA study investigators. Effect of early postextubation high-flow nasal cannula vs conventional oxygen therapy on hypoxaemia in patients after major abdominal surgery: a French multicentre randomised controlled trial (OPERA). Intensive Care Med. 2016 Dec;42(12):1888-1898. doi: 10.1007/s00134-016-4594-y. Epub 2016 Oct 22.</citation>
    <PMID>27771739</PMID>
  </results_reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>October 25, 2022</last_update_submitted>
  <last_update_submitted_qc>October 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fu Jen Catholic University</investigator_affiliation>
    <investigator_full_name>Ke-Yun, Chao</investigator_full_name>
    <investigator_title>Group leader of Respiratory Therapists</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <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/NCT03811158
org study id: PL-201705001-M
nct id: NCT03811158
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients with COPD exacerbation usually need respiratory support after extubation. Recently,
      HHHFNC has been used in both adult and neonates with post-extubation respiratory support.
      Studies indicate that HHHFNC has seminar efficacy compared to non-invasive positive pressure
      ventilation and superior than conventional oxygen therapy. There are no clinical data of
      diaphragm electrical activity and cardiopulmonary function for using HHHFNC and UHFOM as
      post-extubation respiratory support.
Objectives： The aim of this study is to compare the Edi level and cardiopulmonary parameters
      between heated humidified high-flow nasal cannula (HHHFNC) versus unheated high-flow oxygen
      mask (UHFOM) in acute exacerbation of chronic obstructive pulmonary disease (COPD) patients
      with post-extubation respiratory support. This is the first clinical trial to investigate and
      analysis the variations of cardiopulmonary parameters and Edi level between HHHFNC and UHFOM
      in adult patients.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Patents with COPD exacerbation who were intubated for respiratory failure will all enrolled to this study. Participants will be studied on 2 consecutive days and random assigned with crossover. The primary outcome measure is the diaphragm electrical activity. The secondary outcome measures include the cardiopulmonary function, length of hospital stay, and re-intubation rate.
primary purpose: Treatment
masking: Single (Investigator)
masking description: All data will be decoded before biostatics analysis
measure: Diaphragm electrical activity
time frame: 2 days
description: In voltage
measure: PtcO2 & PtcCO2
time frame: 2 days
description: In mmHg
measure: Re-intubation rate
time frame: 2 days
description: In %
measure: Cardiac index
time frame: 2 days
description: In L/min/m2
measure: Hospital stay
time frame: through study completion, an average 3 months
description: In days
measure: ICU stay
time frame: through study completion, an average 1 months
description: In days
arm group label: HHHFNC group
arm group type: Experimental
description: On HHHFNC FiO2 will setting as same as SBT before extubation Flow rate: 50L/min
arm group label: UHFOM group
arm group type: Sham Comparator
description: On Aerosol mask FiO2 will setting as same as SBT before extubation Flow rate: 15L/min
intervention type: Device
intervention name: HHHFNC
description: Prospective, randomized crossover control trial, single ICU. Patents with COPD exacerbation who were intubated for respiratory failure will all enrolled to this study. Participants will be studied on 2 consecutive days and random assigned with crossover.
arm group label: HHHFNC group
other name: Study group
intervention type: Device
intervention name: UHFOM
description: Prospective, randomized crossover control trial, single ICU. Patents with COPD exacerbation who were intubated for respiratory failure will all enrolled to this study. Participants will be studied on 2 consecutive days and random assigned with crossover.
arm group label: UHFOM group
other name: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ke-Yun Chao, M.Sc
role: Principal Investigator
affiliation: ck_qq@hotmail.com
facility: 
country: Taiwan
citation: Brotfain E, Zlotnik A, Schwartz A, Frenkel A, Koyfman L, Gruenbaum SE, Klein M. Comparison of the effectiveness of high flow nasal oxygen cannula vs. standard non-rebreather oxygen face mask in post-extubation intensive care unit patients. Isr Med Assoc J. 2014 Nov;16(11):718-22.
PMID: 25558703
citation: Stephan F, Barrucand B, Petit P, Rezaiguia-Delclaux S, Medard A, Delannoy B, Cosserant B, Flicoteaux G, Imbert A, Pilorge C, Berard L; BiPOP Study Group. High-Flow Nasal Oxygen vs Noninvasive Positive Airway Pressure in Hypoxemic Patients After Cardiothoracic Surgery: A Randomized Clinical Trial. JAMA. 2015 Jun 16;313(23):2331-9. doi: 10.1001/jama.2015.5213.
PMID: 25980660
citation: Futier E, Paugam-Burtz C, Godet T, Khoy-Ear L, Rozencwajg S, Delay JM, Verzilli D, Dupuis J, Chanques G, Bazin JE, Constantin JM, Pereira B, Jaber S; OPERA study investigators. Effect of early postextubation high-flow nasal cannula vs conventional oxygen therapy on hypoxaemia in patients after major abdominal surgery: a French multicentre randomised controlled trial (OPERA). Intensive Care Med. 2016 Dec;42(12):1888-1898. doi: 10.1007/s00134-016-4594-y. Epub 2016 Oct 22.
PMID: 27771739
responsible party type: Principal Investigator
investigator affiliation: Fu Jen Catholic University
investigator full name: Ke-Yun, Chao
investigator title: Group leader of Respiratory Therapists
mesh term: Lung Diseases
mesh term: Respiratory Insufficiency
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No