<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/NCT02972021</url>
  </required_header>
  <id_info>
    <org_study_id>shsk20160722</org_study_id>
    <nct_id>NCT02972021</nct_id>
  </id_info>
  <brief_title>High Flow Nasal Cannulae Oxygen Therapy in Respiratory Insufficiency Patients</brief_title>
  <official_title>High Flow Nasal Cannulae Oxygen Therapy in Respiratory Insufficiency Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai 10th People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai 10th People's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic respiratory insufficiency in patients with advanced disease to the late treatment&#xD;
      depends mainly on mechanical ventilation and other high intensity respiratory support&#xD;
      therapy. Strengthen the stability of chronic respiratory insufficiency intervention can&#xD;
      reduce the frequency and extent of acute disease, saving medical resources.High-flow nasal&#xD;
      cannula (HFNC), as a new non-invasive oxygen therapy system, has gradually become a weapon of&#xD;
      respiratory support therapy. There is little research on the role of HFNC in oxygen therapy&#xD;
      for chronic respiratory insufficiency.&#xD;
&#xD;
      Our previous studies have found the potential value of HFNC in chronic respiratory&#xD;
      insufficiency. The aim of this project is to promote the use of HFNC in the t reatment of&#xD;
      chronic respiratory insufficiency in HFRS in Shanghai first, second and third grade hospitals&#xD;
      in an effort to confirm that HFNC can improve the prognosis of patients with chronic&#xD;
      respiratory insufficiency compared with nasal oxygen therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. To confirm HFNC used in patients with chronic respiratory insufficiency oxygen therapy&#xD;
           than the general nasal catheter oxygen and the difference between what better.&#xD;
&#xD;
        2. We set up a point of research in the tertiary hospitals, secondary hospitals and primary&#xD;
           hospitals to explore the different levels of HFNC in the application of the efficacy of&#xD;
           the hospital there are differences and what is better. To further clarify the promotion&#xD;
           of HFNC to secondary hospitals and primary hospitals have no meaning.&#xD;
&#xD;
        3. Patients with chronic respiratory insufficiency who required long-term oxygen therapy&#xD;
           were randomized to a randomized, controlled, multicentre clinical trial of HFNC with&#xD;
           nasal oxygen therapy. Analysis and comparison of HFNC and general nasal catheter oxygen&#xD;
           in the treatment of chronic respiratory insufficiency there is no difference, HFNC in&#xD;
           different grades of hospital use is consistent.&#xD;
&#xD;
        4. Research methods:&#xD;
&#xD;
      4.1 Subjects: Chronic respiratory insufficiency required long-term oxygen therapy to Shanghai&#xD;
      Tenth People's Hospital and multi-center hospital patients.&#xD;
&#xD;
      4.2 Study sample size: 100 samples were collected from each of the three test centers. Of&#xD;
      which 150 cases of nasal oxygen therapy, HFNC 150 cases.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <primary_completion_date type="Anticipated">December 2018</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>Improve dyspnea score</measure>
    <time_frame>up to 12 months after oxygen therapy</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>up to 12 months after oxygen therapy</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Patients With Respiratory Insufficiency</condition>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Pure oxygen by nasal cannula group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HFNC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>oxygen by High-flow nasal cannula</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>High-flow nasal cannula</intervention_name>
    <arm_group_label>HFNC</arm_group_label>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Patients with chronic respiratory insufficiency who require long-term oxygen therapy.&#xD;
&#xD;
        Age 18-85 years old. Agree to participate in this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Patients with advanced respiratory support (invasive mechanical ventilation, noninvasive&#xD;
        mechanical ventilation) indications Cardiovascular disease caused by respiratory&#xD;
        insufficiency Immune dysfunction caused by respiratory insufficiency Tumor-induced&#xD;
        respiratory insufficiency People with disturbance of consciousness&#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_contact>
    <last_name>HU PENG, MD</last_name>
    <phone>+821666304586</phone>
    <email>denkepeng@189.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>YUANZHUO CHEN, MD</last_name>
    <phone>+821666304586</phone>
    <email>chenyuanzhuo021@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Shanghai Tenth Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200072</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>HU PENG, MD</last_name>
      <email>chenyuanzhuo021@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>November 21, 2016</last_update_submitted>
  <last_update_submitted_qc>November 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai 10th People's Hospital</investigator_affiliation>
    <investigator_full_name>Chen Yuanzhuo</investigator_full_name>
    <investigator_title>department of emergency</investigator_title>
  </responsible_party>
  <keyword>respiratory insufficiency</keyword>
  <keyword>High-flow nasal cannula</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
  </condition_browse>
  <!-- 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/NCT02972021
org study id: shsk20160722
nct id: NCT02972021
lead sponsor: 
has dmc: Yes
Chronic respiratory insufficiency in patients with advanced disease to the late treatment
      depends mainly on mechanical ventilation and other high intensity respiratory support
      therapy. Strengthen the stability of chronic respiratory insufficiency intervention can
      reduce the frequency and extent of acute disease, saving medical resources.High-flow nasal
      cannula (HFNC), as a new non-invasive oxygen therapy system, has gradually become a weapon of
      respiratory support therapy. There is little research on the role of HFNC in oxygen therapy
      for chronic respiratory insufficiency.

      Our previous studies have found the potential value of HFNC in chronic respiratory
      insufficiency. The aim of this project is to promote the use of HFNC in the t reatment of
      chronic respiratory insufficiency in HFRS in Shanghai first, second and third grade hospitals
      in an effort to confirm that HFNC can improve the prognosis of patients with chronic
      respiratory insufficiency compared with nasal oxygen therapy.
1. To confirm HFNC used in patients with chronic respiratory insufficiency oxygen therapy
           than the general nasal catheter oxygen and the difference between what better.

        2. We set up a point of research in the tertiary hospitals, secondary hospitals and primary
           hospitals to explore the different levels of HFNC in the application of the efficacy of
           the hospital there are differences and what is better. To further clarify the promotion
           of HFNC to secondary hospitals and primary hospitals have no meaning.

        3. Patients with chronic respiratory insufficiency who required long-term oxygen therapy
           were randomized to a randomized, controlled, multicentre clinical trial of HFNC with
           nasal oxygen therapy. Analysis and comparison of HFNC and general nasal catheter oxygen
           in the treatment of chronic respiratory insufficiency there is no difference, HFNC in
           different grades of hospital use is consistent.

        4. Research methods:

      4.1 Subjects: Chronic respiratory insufficiency required long-term oxygen therapy to Shanghai
      Tenth People's Hospital and multi-center hospital patients.

      4.2 Study sample size: 100 samples were collected from each of the three test centers. Of
      which 150 cases of nasal oxygen therapy, HFNC 150 cases.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Improve dyspnea score
time frame: up to 12 months after oxygen therapy
measure: Length of hospital stay
time frame: up to 12 months after oxygen therapy
arm group label: control
arm group type: Other
description: Pure oxygen by nasal cannula group
arm group label: HFNC
arm group type: Experimental
description: oxygen by High-flow nasal cannula
intervention type: Device
intervention name: High-flow nasal cannula
arm group label: HFNC
arm group label: control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: HU PENG, MD
phone: +821666304586
email: denkepeng@189.cn
last name: YUANZHUO CHEN, MD
phone: +821666304586
email: chenyuanzhuo021@hotmail.com
facility: 
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai 10th People's Hospital
investigator full name: Chen Yuanzhuo
investigator title: department of emergency
mesh term: Respiratory Insufficiency