<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/NCT03244761</url>
  </required_header>
  <id_info>
    <org_study_id>KY-2017-CC-13</org_study_id>
    <nct_id>NCT03244761</nct_id>
  </id_info>
  <brief_title>Physiological Effects of High-Flow Tracheal Oxygen Via An Modified Interface</brief_title>
  <official_title>Physiological Effects of High-Flow Tracheal Oxygen Via An Modified Interface in Tracheostomized Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Capital Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Capital Medical University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Tracheostomy is often performed in patients after or anticipated prolonged mechanical&#xD;
      ventilation, who are usually required oxygen therapy after discontinuation of mechanical&#xD;
      ventilation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Tracheostomy is often performed in patients after or anticipated prolonged mechanical&#xD;
      ventilation, who are usually required oxygen therapy after discontinuation of mechanical&#xD;
      ventilation.The high-flow tracheal (HFT) oxygen therapy in tracheostomized patients has been&#xD;
      shown that can improve oxygenation,but can not induce positive end-expiratory pressure and&#xD;
      elevation of end-expiratory lung volume. A modified HFT system by increasing expiratory&#xD;
      resistance might induce PEEP and consequently elevate EELV.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">February 5, 2018</completion_date>
  <primary_completion_date type="Actual">September 15, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The mean end expiratory pressure.</measure>
    <time_frame>the last 1 minutes of steady breathing during the standard or modified HFT.</time_frame>
    <description>The patients was delivering the high flow oxygen via the standard and modified HFT interface for 20 minutes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in global and regional EELV</measure>
    <time_frame>the last 1 minutes of steady breathing during the standard or modified HFT.</time_frame>
    <description>The Electrical impedance tomography (EIT) was applied in monitoring the change of EELV at the bedside.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Tracheostomy</condition>
  <arm_group>
    <arm_group_label>The standard HFT</arm_group_label>
    <description>The high-flow oxygen was delivered via tracheostomy using a standard HFT.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>The modified HFT</arm_group_label>
    <description>The high-flow oxygen was delivered via tracheostomy using a modified HFT.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>The modified HFT</intervention_name>
    <description>The HFT was modified by increasing the expiratory resistance.</description>
    <arm_group_label>The modified HFT</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The tracheostomized patient&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The tracheostomized patient requiring the convenient oxygen therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 18 years;&#xD;
&#xD;
          -  history of esophageal, gastric or lung surgery;&#xD;
&#xD;
          -  The contraindication of using EIT (pacemaker, defibrillator, and implantable pumps).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Jian-Xin Zhou, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Tiantan Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jian-Xin Zhou</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100050</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>February 9, 2018</last_update_submitted>
  <last_update_submitted_qc>February 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Capital Medical University</investigator_affiliation>
    <investigator_full_name>Jian-Xin Zhou</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>high flow tracheal oxygen</keyword>
  <keyword>modified interface</keyword>
  <!-- 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/NCT03244761
org study id: KY-2017-CC-13
nct id: NCT03244761
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Tracheostomy is often performed in patients after or anticipated prolonged mechanical
      ventilation, who are usually required oxygen therapy after discontinuation of mechanical
      ventilation.
Tracheostomy is often performed in patients after or anticipated prolonged mechanical
      ventilation, who are usually required oxygen therapy after discontinuation of mechanical
      ventilation.The high-flow tracheal (HFT) oxygen therapy in tracheostomized patients has been
      shown that can improve oxygenation,but can not induce positive end-expiratory pressure and
      elevation of end-expiratory lung volume. A modified HFT system by increasing expiratory
      resistance might induce PEEP and consequently elevate EELV.
observational model: Case-Crossover
time perspective: Prospective
measure: The mean end expiratory pressure.
time frame: the last 1 minutes of steady breathing during the standard or modified HFT.
description: The patients was delivering the high flow oxygen via the standard and modified HFT interface for 20 minutes.
measure: Changes in global and regional EELV
time frame: the last 1 minutes of steady breathing during the standard or modified HFT.
description: The Electrical impedance tomography (EIT) was applied in monitoring the change of EELV at the bedside.
arm group label: The standard HFT
description: The high-flow oxygen was delivered via tracheostomy using a standard HFT.
arm group label: The modified HFT
description: The high-flow oxygen was delivered via tracheostomy using a modified HFT.
intervention type: Procedure
intervention name: The modified HFT
description: The HFT was modified by increasing the expiratory resistance.
arm group label: The modified HFT
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
last name: Jian-Xin Zhou, MD
role: Principal Investigator
affiliation: Beijing Tiantan Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Capital Medical University
investigator full name: Jian-Xin Zhou
investigator title: Professor