<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/NCT04500392</url>
  </required_header>
  <id_info>
    <org_study_id>HFNOIO</org_study_id>
    <nct_id>NCT04500392</nct_id>
  </id_info>
  <brief_title>High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Sedated Gastrointestinal Endoscopes in Obesity</brief_title>
  <official_title>High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Sedated Gastrointestinal Endoscopes in Obesity: a Randomized Multicenter Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RenJi Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shanghai Tongji Hospital, Tongji University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Oriental Hospital, Tongji University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>RenJi Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypoxia is the most common adverse event during gastrointestinal endoscopes sedated with&#xD;
      propofol and sufentanil, especially in obese people. In the present study, high-flow nasal&#xD;
      cannula oxygenation will be utilized in order to reduce the incidence of hypoxia among&#xD;
      obesity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 6, 2021</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</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>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence of hypoxia</measure>
    <time_frame>Patients will be followed for the duration of hospital stay, an expected average of 2 hours]</time_frame>
    <description>(75% ≤ SpO2 &lt; 90% for &lt;60 s)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The incidence of subclinical respiratory depression</measure>
    <time_frame>Patients will be followed for the duration of hospital stay, an expected average of 2 hours</time_frame>
    <description>(90% ≤ SpO2 &lt; 95%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of severe hypoxia</measure>
    <time_frame>Patients will be followed for the duration of hospital stay, an expected average of 2 hours</time_frame>
    <description>(SpO2 &lt; 75% for any duration or 75% &lt; SpO2 &lt; 90% for &gt;/=60 s)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other adverse events include other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force and HFNC supportive oxygen therapy-related adverse events.</measure>
    <time_frame>Patients will be followed for the duration of hospital stay, an expected average of 2 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Hypoxia</condition>
  <condition>Gastric Cancer</condition>
  <condition>Esophagus Cancer</condition>
  <condition>Polyp of Colon</condition>
  <condition>Colon Cancer</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Oxygen(up to 6L/min) supplied with a regular nasal catheter</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High-flow nasal cannula group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oxygen(up to 60L/min) supplied with high-flow nasal cannula</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>High-flow nasal cannula oxygenation</intervention_name>
    <description>Oxygen is supplied with a high-flow nasal cannula oxygenation device#the flow is up to 60L/min</description>
    <arm_group_label>High-flow nasal cannula group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Regular nasal cannula</intervention_name>
    <description>Oxygen is supplied with a regular nasal cannula #the flow is up to 6L/min</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients undergoing gastrointestinal endoscopes&#xD;
&#xD;
          -  age≥18 years old and ≤70 years old&#xD;
&#xD;
          -  patients or family members signed informed consent form&#xD;
&#xD;
          -  ASA classification I-II&#xD;
&#xD;
          -  BMI≥ 28kg/m²&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Coagulation disorders or a tendency of nose bleeding;&#xD;
&#xD;
          -  An episode/exacerbation of congestive heart failure (CHF) that requires a change in&#xD;
             medication, diet or hospitalization from any cause in the last 6 months;&#xD;
&#xD;
          -  Severe aortic stenosis or mitral stenosis;&#xD;
&#xD;
          -  Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft (CABG),&#xD;
             valve replacement surgery) in the last 6 months;&#xD;
&#xD;
          -  Acute myocardial infarction in the last 6 months;&#xD;
&#xD;
          -  Acute arrhythmia (including any tachycardia - or bradycardia) with the fluid of&#xD;
             hemodynamics instability;&#xD;
&#xD;
          -  Diagnosed chronic obstructive pulmonary disease or current other acute or chronic lung&#xD;
             disease requiring supplemental chronic or intermittent oxygen therapy);&#xD;
&#xD;
          -  Increased intracranial pressure;&#xD;
&#xD;
          -  ASA classification Ⅲ-Ⅳ ;&#xD;
&#xD;
          -  Mouth, nose, or throat infection;&#xD;
&#xD;
          -  Liver and kidney disease&#xD;
&#xD;
          -  Fever, defined as core body temperature &gt; 37.5℃;&#xD;
&#xD;
          -  Pregnancy, breastfeeding or positive pregnancy test;&#xD;
&#xD;
          -  Emergency procedure;&#xD;
&#xD;
          -  Patients or family members refused to participate&#xD;
&#xD;
          -  Mental disorders and people without civil capacity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Diansan Su, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Renji Hospital, Shanghai Jiaotong University, Shanghai, China</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Diansan Su, Dr.</last_name>
    <phone>+862168383702</phone>
    <email>diansansu@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shanghai Tongji Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai, China</state>
        <zip>200065</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaoqing Zhang, M.S.</last_name>
      <email>xq_820175@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanghai Oriental Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai, China</state>
        <zip>200120</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiangrui Wang, Dr.</last_name>
      <email>wangxr2010@yahoo.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Renji hospital, School of Medicine, Shanghai Jiaotong University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai, China</state>
        <zip>200127</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhang Yuanyuan, B.S.</last_name>
      <phone>+862168383702</phone>
      <email>2630643807@qq.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 2, 2020</study_first_submitted>
  <study_first_submitted_qc>August 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>September 14, 2021</last_update_submitted>
  <last_update_submitted_qc>September 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>RenJi Hospital</investigator_affiliation>
    <investigator_full_name>diansan su</investigator_full_name>
    <investigator_title>Vice Chair of the Department of Anesthesiology</investigator_title>
  </responsible_party>
  <keyword>Hypoxia</keyword>
  <keyword>Gastrointestinal endoscopes</keyword>
  <keyword>High-flow nasal cannula Oxygenation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophageal Neoplasms</mesh_term>
    <mesh_term>Hypoxia</mesh_term>
    <mesh_term>Colonic Polyps</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/NCT04500392
org study id: HFNOIO
nct id: NCT04500392
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Hypoxia is the most common adverse event during gastrointestinal endoscopes sedated with
      propofol and sufentanil, especially in obese people. In the present study, high-flow nasal
      cannula oxygenation will be utilized in order to reduce the incidence of hypoxia among
      obesity.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: The incidence of hypoxia
time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours]
description: (75% ≤ SpO2 < 90% for <60 s)
measure: The incidence of subclinical respiratory depression
time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
description: (90% ≤ SpO2 < 95%)
measure: The incidence of severe hypoxia
time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
description: (SpO2 < 75% for any duration or 75% < SpO2 < 90% for >/=60 s)
measure: Other adverse events include other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force and HFNC supportive oxygen therapy-related adverse events.
time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
arm group label: Control group
arm group type: Active Comparator
description: Oxygen(up to 6L/min) supplied with a regular nasal catheter
arm group label: High-flow nasal cannula group
arm group type: Experimental
description: Oxygen(up to 60L/min) supplied with high-flow nasal cannula
intervention type: Device
intervention name: High-flow nasal cannula oxygenation
description: Oxygen is supplied with a high-flow nasal cannula oxygenation device#the flow is up to 60L/min
arm group label: High-flow nasal cannula group
intervention type: Device
intervention name: Regular nasal cannula
description: Oxygen is supplied with a regular nasal cannula #the flow is up to 6L/min
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Diansan Su, Dr.
role: Principal Investigator
affiliation: Renji Hospital, Shanghai Jiaotong University, Shanghai, China
last name: Diansan Su, Dr.
phone: +862168383702
email: diansansu@yahoo.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: RenJi Hospital
investigator full name: diansan su
investigator title: Vice Chair of the Department of Anesthesiology
mesh term: Esophageal Neoplasms
mesh term: Hypoxia
mesh term: Colonic Polyps