<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/NCT03014869</url>
  </required_header>
  <id_info>
    <org_study_id>2016YFC1304304-2</org_study_id>
    <nct_id>NCT03014869</nct_id>
  </id_info>
  <brief_title>High Flow Nasal Cannula vs NPPV in Moderate Chronic Obstructive Pulmonary Disease Exacerbation</brief_title>
  <official_title>Comparison of High Flow Nasal Cannula and Noninvasive Positive Ventilation(NPPV) in Moderate 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 moderate AECOPD(pH&lt;7.35), several guidelines have strongly recommended NPPV as standard&#xD;
      therapy, which can reduce the rate of intubation and mortality. A few previous studies have&#xD;
      shown that HFNC can efficiently improve alveoli ventilation and breathing pattern in some&#xD;
      severe AECOPD patients. Therefore, we hypothesize that HFNC is not inferior to NPPV for&#xD;
      preventing endotracheal intubation in moderate AECOPD patients. To assess this hypothesis, we&#xD;
      performed a multicenter, randomized, noninferiority trial of HFNV vs NPPV in moderate AECOPD&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recently, many clinical studies have showed that HFNC can be successfully used in patients&#xD;
      with hypoxemic respiratory failure to improve the comfort, to attenuate respiratory failure&#xD;
      and to decrease the rate of tracheal intubation and mortality. Although theoretically HFNC is&#xD;
      a potential and ideal treatment for AECOPD patients, the related clinical researches are very&#xD;
      few. It still needs to further evaluate the safety and efficacy of HFNC in patients with&#xD;
      AECOPD. For moderate AECOPD(pH&lt;7.35), several guidelines have strongly recommended NPPV as&#xD;
      standard therapy, which can reduce the rate of intubation and mortality. A few previous&#xD;
      studies have shown that HFNC can efficiently improve alveoli ventilation and breathing&#xD;
      pattern in some severe AECOPD patients. Therefore, we hypothesize that HFNC is not inferior&#xD;
      to NPPV for preventing endotracheal intubation in moderate AECOPD patients. To assess this&#xD;
      hypothesis, we performed a multicenter, randomized, noninferiority trial of HFNV vs NPPV in&#xD;
      moderate AECOPD patients.&#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">351</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 degree centigrade.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Noninvasive positive ventilation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Parameters are set according to NPPV protocols</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; 7.35&gt;pH≥7.25，PaCO2&gt;50 mmHg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contraindications for NPPV, such as thick sputum, cough weakness, hemodynamic&#xD;
             instability, etc.; need to be intubated immediately; refuse to engage in the study;&#xD;
             severe organ 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>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</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>Noninvasive Positive Ventilation</keyword>
  <keyword>moderate</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/NCT03014869
org study id: 2016YFC1304304-2
nct id: NCT03014869
lead sponsor: 
has dmc: No
For moderate AECOPD(pH<7.35), several guidelines have strongly recommended NPPV as standard
      therapy, which can reduce the rate of intubation and mortality. A few previous studies have
      shown that HFNC can efficiently improve alveoli ventilation and breathing pattern in some
      severe AECOPD patients. Therefore, we hypothesize that HFNC is not inferior to NPPV for
      preventing endotracheal intubation in moderate AECOPD patients. To assess this hypothesis, we
      performed a multicenter, randomized, noninferiority trial of HFNV vs NPPV in moderate AECOPD
      patients.
Recently, many clinical studies have showed that HFNC can be successfully used in patients
      with hypoxemic respiratory failure to improve the comfort, to attenuate respiratory failure
      and to decrease the rate of tracheal intubation and mortality. Although theoretically HFNC is
      a potential and ideal treatment for AECOPD patients, the related clinical researches are very
      few. It still needs to further evaluate the safety and efficacy of HFNC in patients with
      AECOPD. For moderate AECOPD(pH<7.35), several guidelines have strongly recommended NPPV as
      standard therapy, which can reduce the rate of intubation and mortality. A few previous
      studies have shown that HFNC can efficiently improve alveoli ventilation and breathing
      pattern in some severe AECOPD patients. Therefore, we hypothesize that HFNC is not inferior
      to NPPV for preventing endotracheal intubation in moderate AECOPD patients. To assess this
      hypothesis, we performed a multicenter, randomized, noninferiority trial of HFNV vs NPPV in
      moderate AECOPD patients.
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 degree centigrade.
arm group label: Noninvasive positive ventilation
arm group type: No Intervention
description: Parameters are set according to NPPV protocols
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