<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/NCT03003559</url>
  </required_header>
  <id_info>
    <org_study_id>2016YFC1304304-1</org_study_id>
    <nct_id>NCT03003559</nct_id>
  </id_info>
  <brief_title>HFNC vs Nasal Cannula in Mild Chronic Obstructive Pulmonary Disease Exacerbation</brief_title>
  <official_title>Comparison of High Flow Nasal Cannula vs Nasal Cannula in Mild Chronic Obstructive Pulmonary Disease Exacerbation(AECOPD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China-Japan Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China-Japan Friendship Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      For AECOPD patients, only 8% patients ventilated by noninvasive and invasive positive&#xD;
      pressure ventilation. Nasal cannula is the most common pattern of oxygen therapy in mild&#xD;
      AECOPD. As a low flow oxygen therapy, nasal cannula has many disadvantages.Therefore, we&#xD;
      design a randomized controlled trial(RCT)to explore whether HFNC would be better than nasal&#xD;
      cannula to prevent the aggravation of respiratory failure and endotracheal intubation in mild&#xD;
      AECOPD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For AECOPD patients, most of patients don't need respiratory support, only 8% patients&#xD;
      ventilated by noninvasive and invasive positive pressure ventilation. Nasal cannula is the&#xD;
      most common pattern of oxygen therapy in mild AECOPD. As a low flow oxygen therapy, nasal&#xD;
      cannula has many disadvantages: discomfort, low humidity and unstable fraction of inspired&#xD;
      oxygen(FiO2) in inspiratory gas. Therefore, we design a RCT to explore whether HFNC would be&#xD;
      better than nasal cannula to prevent the aggravation of respiratory failure and endotracheal&#xD;
      intubation in mild AECOPD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>endotracheal intubation demand rate</measure>
    <time_frame>90days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>actual endotracheal intubation rate</measure>
    <time_frame>90days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">328</enrollment>
  <condition>COPD Exacerbation</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(OptiflowTM); Flow 25-60 L/min is set according to patients' comfort; FiO2 is adjusted to maintain peripheral capillary oxygen saturation(SpO2) 90-95%; temperature is set at 37.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nasal cannula</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Nasal cannula;set oxygen flow to keep SpO2 90-95%</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>High flow nasal cannula</intervention_name>
    <description>High flow nasal cannula (HFNC) is a new emerging noninvasive respiratory support technology, which mainly includes high flow (15-60 L/min) device, heating humidification device and nasal cannula for high flow. A large number of physiological studies confirmed that HFNC has the following critical physiological effects: promoting airway humidification, improving tolerance of treatment, reducing the physiological dead space on the upper respiratory tract, producing a certain level of positive end expiratory pressure (2-7 cmH2O), decreasing the work of breathing and so on.</description>
    <arm_group_label>High flow nasal cannula</arm_group_label>
    <other_name>High flow oxygen</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  AECOPD; pH≥7.35, PaCO2&gt;45 mmHg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Need to be intubated immediately; refuse to engage in the study; severe organ&#xD;
             dysfunction&#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>Qingyuan Zhan, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>China-Japan Friendship Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jingen Xia, Master</last_name>
    <phone>13466396561</phone>
    <phone_ext>+86</phone_ext>
    <email>xiajingen_00632@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>China-Japan Friendship hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100028</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chen Wang, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>January 13, 2020</last_update_submitted>
  <last_update_submitted_qc>January 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>China-Japan Friendship Hospital</investigator_affiliation>
    <investigator_full_name>Qingyuan Zhan</investigator_full_name>
    <investigator_title>head of Pulmonary and Critical care medicine ward 4</investigator_title>
  </responsible_party>
  <keyword>COPD Exacerbation</keyword>
  <keyword>High Flow Oxygen</keyword>
  <keyword>Nasal Cannula</keyword>
  <keyword>mild</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Disease Progression</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/NCT03003559
org study id: 2016YFC1304304-1
nct id: NCT03003559
lead sponsor: 
has dmc: No
For AECOPD patients, only 8% patients ventilated by noninvasive and invasive positive
      pressure ventilation. Nasal cannula is the most common pattern of oxygen therapy in mild
      AECOPD. As a low flow oxygen therapy, nasal cannula has many disadvantages.Therefore, we
      design a randomized controlled trial(RCT)to explore whether HFNC would be better than nasal
      cannula to prevent the aggravation of respiratory failure and endotracheal intubation in mild
      AECOPD.
For AECOPD patients, most of patients don't need respiratory support, only 8% patients
      ventilated by noninvasive and invasive positive pressure ventilation. Nasal cannula is the
      most common pattern of oxygen therapy in mild AECOPD. As a low flow oxygen therapy, nasal
      cannula has many disadvantages: discomfort, low humidity and unstable fraction of inspired
      oxygen(FiO2) in inspiratory gas. Therefore, we design a RCT to explore whether HFNC would be
      better than nasal cannula to prevent the aggravation of respiratory failure and endotracheal
      intubation in mild AECOPD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: endotracheal intubation demand rate
time frame: 90days
measure: actual endotracheal intubation rate
time frame: 90days
arm group label: High flow nasal cannula
arm group type: Experimental
description: High flow nasal cannula(OptiflowTM); Flow 25-60 L/min is set according to patients' comfort; FiO2 is adjusted to maintain peripheral capillary oxygen saturation(SpO2) 90-95%; temperature is set at 37.
arm group label: Nasal cannula
arm group type: No Intervention
description: Nasal cannula;set oxygen flow to keep SpO2 90-95%
intervention type: Device
intervention name: High flow nasal cannula
description: High flow nasal cannula (HFNC) is a new emerging noninvasive respiratory support technology, which mainly includes high flow (15-60 L/min) device, heating humidification device and nasal cannula for high flow. A large number of physiological studies confirmed that HFNC has the following critical physiological effects: promoting airway humidification, improving tolerance of treatment, reducing the physiological dead space on the upper respiratory tract, producing a certain level of positive end expiratory pressure (2-7 cmH2O), decreasing the work of breathing and so on.
arm group label: High flow nasal cannula
other name: High flow oxygen
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Qingyuan Zhan, M.D.
role: Principal Investigator
affiliation: China-Japan Friendship Hospital
last name: Jingen Xia, Master
phone: 13466396561
phone ext: +86
email: xiajingen_00632@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: China-Japan Friendship Hospital
investigator full name: Qingyuan Zhan
investigator title: head of Pulmonary and Critical care medicine ward 4
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Disease Progression
sharing ipd: No