<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/NCT03229460</url>
  </required_header>
  <id_info>
    <org_study_id>XH-17-008</org_study_id>
    <nct_id>NCT03229460</nct_id>
  </id_info>
  <brief_title>High Flow Nasal Oxygen Therapy in Perioperative Period of the Adult With Hypercapnic and Hypoxemic Respiratory Faliure</brief_title>
  <official_title>High Flow Nasal Oxygen Therapy in Perioperative Period of the Adult With Hypercapnic and Hypoxemic Respiratory Faliure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the impact of hign-flow nasal therapy on the adult&#xD;
      with hypercapnia and hpoxemia respiratory faliure in comparison with standard oxygen therapy&#xD;
      ang noninvasive ventilation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Humidified high flow nasal oxygen therapy decreases dilution of the inhaled oxygen and, by&#xD;
      matching patient's peak flow, allows accurate delivery of the set FiO2 throughout the whole&#xD;
      inspiratory phase.The purpose of this study is to determine the impact of hign-flow nasal&#xD;
      therapy on adult hypercapnic respiratory failure by comparing with nasal continuous positive&#xD;
      airway pressure&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">August 2019</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</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>the number of patients in each group who require endotracheal intubation with mechanical ventilation</measure>
    <time_frame>28days</time_frame>
    <description>To compare the number of patients in each group who require endotracheal intubation with mechanical ventilation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>mechanical ventilation-free to day 28</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Acute Respiratory Failure With Hypercapnia</condition>
  <arm_group>
    <arm_group_label>standard low flow therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In the standard low flow therapy is applied continuously through a nonrebreather face mask at a flow rate of 10 liters per minute or more. The rate was adjusted to maintain an oxygen saturation level of 92% or more.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>high flow nasal oxygen therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the high-flow-oxygen group is passed through a heated humidifier and applied continuously through large-bore binasal prongs, with a gas flow rate of 30-60 liters per minute . The fraction of oxygen in the gas flowing in the system was subsequently adjusted to maintain an Spo2 of 92% or more.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Noninvasive ventilation</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>In the noninvasive-ventilation group is delivered to the patient through a face mask that was connected to an ICU ventilator,with pressure support applied in a noninvasive ventilation mode. The Fio2 or PEEP level (or both) were then adjusted to maintain an Spo2 of 92% or more.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>standard low flow therapy</intervention_name>
    <description>In the standard low flow therapy oxygen group, oxygen at a flow rate of 10 liters per minute or more.</description>
    <arm_group_label>standard low flow therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>high flow nasal oxygen therapy</intervention_name>
    <description>The patient will receive high flow nasal of humidified oxygen, set between 30 to 60 l/min. The inspired fraction of oxygen (FiO2) will be adjusted in order to obtain a SpO2 &gt;92%.</description>
    <arm_group_label>high flow nasal oxygen therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>association of high flow nasal oxygen therapy and non invasive positive pressure ventilation</intervention_name>
    <description>The patient will receive successively in a day NPPV and O2-HFN. The NPPV will be applied with an airway humidification achieved by using a heated humidifier and a facial mask adapted to the morphology of the patient. The settings will be adjusted as follow : an inspiratory pressure between 6 to 14 cmH2O, in order to obtain a tidal volume between 7 to 10 ml/kg of predicted weight, a positive expiratory pressure between 0 to 10 cmH2O in order to obtain a SpO2 &gt;92% with the minimal FiO2.</description>
    <arm_group_label>Noninvasive ventilation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hypoxemic and no hypercapnic acute respiratory failure :&#xD;
&#xD;
          -  severe dyspnea at rest with a respiratory rate &gt;25 breaths/min&#xD;
&#xD;
          -  PaO2/FiO2 &lt;300&#xD;
&#xD;
          -  PaCO2 &lt;45 mmHg,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt;18 years&#xD;
&#xD;
          -  NPPV contraindications&#xD;
&#xD;
          -  past history of respiratory chronic disease (COPD, cystic fibrosis…)&#xD;
&#xD;
          -  cardiac pulmonary edema&#xD;
&#xD;
          -  Pre-defined intubation&#xD;
&#xD;
          -  other than respiratory organ failure : systolic pressure &lt;90 mmHg,current treatment&#xD;
             with epinephrine or norepinephrine, decreased level of consciousness ( Glasgow score ≤&#xD;
             12)&#xD;
&#xD;
          -  profound aplasia (white cells count &lt;1000/mm 3)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>bin he</last_name>
    <phone>021-25077828</phone>
    <email>hebinicu@139.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>dongjuan tang</last_name>
    <email>317582862@qq.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ethics Committee of Xinhua Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200092</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guangyu Chen, PhD</last_name>
      <phone>+86-02125076143</phone>
      <email>xinhuacru@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>July 23, 2017</study_first_submitted>
  <study_first_submitted_qc>July 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>December 3, 2018</last_update_submitted>
  <last_update_submitted_qc>December 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</investigator_affiliation>
    <investigator_full_name>Bin He</investigator_full_name>
    <investigator_title>M.D./Ph.D.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Hypercapnia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03229460
org study id: XH-17-008
nct id: NCT03229460
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The purpose of this study is to determine the impact of hign-flow nasal therapy on the adult
      with hypercapnia and hpoxemia respiratory faliure in comparison with standard oxygen therapy
      ang noninvasive ventilation.
Humidified high flow nasal oxygen therapy decreases dilution of the inhaled oxygen and, by
      matching patient's peak flow, allows accurate delivery of the set FiO2 throughout the whole
      inspiratory phase.The purpose of this study is to determine the impact of hign-flow nasal
      therapy on adult hypercapnic respiratory failure by comparing with nasal continuous positive
      airway pressure
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: the number of patients in each group who require endotracheal intubation with mechanical ventilation
time frame: 28days
description: To compare the number of patients in each group who require endotracheal intubation with mechanical ventilation
measure: mechanical ventilation-free to day 28
time frame: 28 days
arm group label: standard low flow therapy
arm group type: Active Comparator
description: In the standard low flow therapy is applied continuously through a nonrebreather face mask at a flow rate of 10 liters per minute or more. The rate was adjusted to maintain an oxygen saturation level of 92% or more.
arm group label: high flow nasal oxygen therapy
arm group type: Experimental
description: In the high-flow-oxygen group is passed through a heated humidifier and applied continuously through large-bore binasal prongs, with a gas flow rate of 30-60 liters per minute . The fraction of oxygen in the gas flowing in the system was subsequently adjusted to maintain an Spo2 of 92% or more.
arm group label: Noninvasive ventilation
arm group type: Placebo Comparator
description: In the noninvasive-ventilation group is delivered to the patient through a face mask that was connected to an ICU ventilator,with pressure support applied in a noninvasive ventilation mode. The Fio2 or PEEP level (or both) were then adjusted to maintain an Spo2 of 92% or more.
intervention type: Other
intervention name: standard low flow therapy
description: In the standard low flow therapy oxygen group, oxygen at a flow rate of 10 liters per minute or more.
arm group label: standard low flow therapy
intervention type: Device
intervention name: high flow nasal oxygen therapy
description: The patient will receive high flow nasal of humidified oxygen, set between 30 to 60 l/min. The inspired fraction of oxygen (FiO2) will be adjusted in order to obtain a SpO2 >92%.
arm group label: high flow nasal oxygen therapy
intervention type: Device
intervention name: association of high flow nasal oxygen therapy and non invasive positive pressure ventilation
description: The patient will receive successively in a day NPPV and O2-HFN. The NPPV will be applied with an airway humidification achieved by using a heated humidifier and a facial mask adapted to the morphology of the patient. The settings will be adjusted as follow : an inspiratory pressure between 6 to 14 cmH2O, in order to obtain a tidal volume between 7 to 10 ml/kg of predicted weight, a positive expiratory pressure between 0 to 10 cmH2O in order to obtain a SpO2 >92% with the minimal FiO2.
arm group label: Noninvasive ventilation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: bin he
phone: 021-25077828
email: hebinicu@139.com
last name: dongjuan tang
email: 317582862@qq.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
investigator full name: Bin He
investigator title: M.D./Ph.D.
mesh term: Respiratory Insufficiency
mesh term: Hypercapnia
sharing ipd: Undecided