<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/NCT03019354</url>
  </required_header>
  <id_info>
    <org_study_id>201611036RIN</org_study_id>
    <nct_id>NCT03019354</nct_id>
  </id_info>
  <brief_title>The Effect of Using High-flow Nasal Oxygen-delivery System in Patients Under Intravenous General Anesthesia</brief_title>
  <official_title>The Effect of Using High-flow Nasal Oxygen-delivery System in Patients Under Intravenous General Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In general anesthesia, gas exchange was altered by shunt and uneven ventilation perfusion&#xD;
      ratios. Lung atelectasis was a cause of impaired oxygenation. High-flow nasal cannula oxygen&#xD;
      therapy delivers adequately heated and humidified medical gas at up to 60 L/min of flow. It&#xD;
      has physiological effects: reduction of anatomical dead space, positive end expiratory&#xD;
      pressure (PEEP) effect, constant fraction of inspired oxygen, and good humidification. The&#xD;
      hypothesis of this study is using high-flow nasal oxygen in intravenous general anesthesia&#xD;
      could improve lung function and prevent lung atelectasis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After general anesthesia, almost 90% patients have lung atelectasis. The lung atelectasis&#xD;
      persisted even after the surgery, and caused post operative complication, for example: fever,&#xD;
      pleural effusion, hypoxemia, pneumonia, and respiratory failure. So, how to improve lung&#xD;
      function after the surgery is a important issue. High-flow nasal cannula oxygen therapy&#xD;
      delivers adequately heated and humidified medical gas at up to 60 L/min of flow. It provides&#xD;
      respiratory support: 1. Reduction of dead Space by clearance of expired air in the upper&#xD;
      airways. 2. Delivering positive airway pressure. 3. delivering optimal humidity, which helps&#xD;
      maintain function of the mucociliary transport system, clearing secretions and reducing the&#xD;
      risk of infections. Many reports suggest that high-flow nasal cannula decreases breathing&#xD;
      frequency and work of breathing and reduces intubation rate in critical ill patients.&#xD;
      Although high-flow nasal cannula was used widely in intensive care unit (ICU) , there are no&#xD;
      enough evidence in patients under general anesthesia. The hypothesis of this study is that&#xD;
      using high-flow nasal oxygen in intravenous general anesthesia could improve lung function&#xD;
      and prevent lung atelectasis. Liver tumor radiofrequency ablation was performed sometimes in&#xD;
      patients under general anesthesia. Intravenous general anesthesia is one of the anesthesia&#xD;
      choice. Oxygen mask is the traditional oxygen delivery system. Apnea, hypoxemia, and CO2&#xD;
      retention are common situation in intravenous general anesthesia. So high-flow nasal oxygen&#xD;
      is an ideal oxygen delivery system in intravenous general anesthesia. This randomized control&#xD;
      study will enroll patients receiving CT guided liver tumor radiofrequency ablation under&#xD;
      general anesthesia. One group will receive high-flow nasal oxygen, the other group will&#xD;
      receive traditional oxygen mask. The primary outcome is lung atelectasis area in CT scan. The&#xD;
      secondary outcome is respiratory function (for example: arterial blood gas, lung injury&#xD;
      biomarkers, saturation, postoperative pulmonary complication)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">January 2019</completion_date>
  <primary_completion_date type="Anticipated">January 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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Chest CT image atelectatic area</measure>
    <time_frame>At the end of surgery</time_frame>
    <description>lung atelectasis (-100 to +100 Hounsfield Unit) was calculated and as percent of the total area of the lung at the basal scan.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>postoperative pulmonary complications</measure>
    <time_frame>within the first 7 days after surgery</time_frame>
    <description>postoperative pulmonary complications including pneumonia, pleural effusion, and acute lung injury.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>lung injury</measure>
    <time_frame>At the end of surgery</time_frame>
    <description>lung injury biomarkers including Clara cell protein, Plasma neutrophil elastase.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Respiratory gas exchange function</measure>
    <time_frame>At the end of surgery</time_frame>
    <description>blood gas analysis including PaO2, PaCO2</description>
  </other_outcome>
  <other_outcome>
    <measure>need for supplemental oxygen therapy</measure>
    <time_frame>within the first 7 days after surgery</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Pulmonary Atelectases</condition>
  <condition>Lung Injury</condition>
  <condition>General Anesthesia</condition>
  <arm_group>
    <arm_group_label>high-flow nasal oxygen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>high-flow nasal oxygen was used during intravenous general anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oxygen mask</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>oxygen mask was used during intravenous general anesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>high-flow nasal oxygen</intervention_name>
    <description>Using high-flow nasal oxygen 10 L/min before anesthesia induction, then using high-flow nasal oxygen 30-50 L/min during intravenous general anesthesia.</description>
    <arm_group_label>high-flow nasal oxygen</arm_group_label>
    <other_name>High-flow nasal cannula</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Oxygen mask</intervention_name>
    <description>Using oxygen mask with oxygen flow 10 L/min before and during intravenous general anesthesia.</description>
    <arm_group_label>Oxygen mask</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with hepatic tumor undergoing CT guided radiofrequency ablation&#xD;
&#xD;
          -  Age &gt; 20 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiac dysfunction, such as heart failure &gt; NYHA class II, coronary arterial disease&#xD;
&#xD;
          -  Impaired renal function, cGFR&lt; 60 ml/min/1.73 m2&#xD;
&#xD;
          -  Pulmonary disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chun-Yu Wu, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chung-Chih Shih, MD</last_name>
    <phone>+886 911674300</phone>
    <email>s6319138@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Chung-Chih Shih, MD</last_name>
    <phone>+886 972653379</phone>
    <email>s6319138@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>10048</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chung CHih SHih, MD</last_name>
      <phone>+886 972653379</phone>
      <email>s6319138@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>May 28, 2018</last_update_submitted>
  <last_update_submitted_qc>May 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>high flow oxygen</keyword>
  <keyword>pulmonary atelectasis</keyword>
  <keyword>intravenous general anesthesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Injury</mesh_term>
    <mesh_term>Pulmonary Atelectasis</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/NCT03019354
org study id: 201611036RIN
nct id: NCT03019354
lead sponsor: 
has dmc: No
In general anesthesia, gas exchange was altered by shunt and uneven ventilation perfusion
      ratios. Lung atelectasis was a cause of impaired oxygenation. High-flow nasal cannula oxygen
      therapy delivers adequately heated and humidified medical gas at up to 60 L/min of flow. It
      has physiological effects: reduction of anatomical dead space, positive end expiratory
      pressure (PEEP) effect, constant fraction of inspired oxygen, and good humidification. The
      hypothesis of this study is using high-flow nasal oxygen in intravenous general anesthesia
      could improve lung function and prevent lung atelectasis.
After general anesthesia, almost 90% patients have lung atelectasis. The lung atelectasis
      persisted even after the surgery, and caused post operative complication, for example: fever,
      pleural effusion, hypoxemia, pneumonia, and respiratory failure. So, how to improve lung
      function after the surgery is a important issue. High-flow nasal cannula oxygen therapy
      delivers adequately heated and humidified medical gas at up to 60 L/min of flow. It provides
      respiratory support: 1. Reduction of dead Space by clearance of expired air in the upper
      airways. 2. Delivering positive airway pressure. 3. delivering optimal humidity, which helps
      maintain function of the mucociliary transport system, clearing secretions and reducing the
      risk of infections. Many reports suggest that high-flow nasal cannula decreases breathing
      frequency and work of breathing and reduces intubation rate in critical ill patients.
      Although high-flow nasal cannula was used widely in intensive care unit (ICU) , there are no
      enough evidence in patients under general anesthesia. The hypothesis of this study is that
      using high-flow nasal oxygen in intravenous general anesthesia could improve lung function
      and prevent lung atelectasis. Liver tumor radiofrequency ablation was performed sometimes in
      patients under general anesthesia. Intravenous general anesthesia is one of the anesthesia
      choice. Oxygen mask is the traditional oxygen delivery system. Apnea, hypoxemia, and CO2
      retention are common situation in intravenous general anesthesia. So high-flow nasal oxygen
      is an ideal oxygen delivery system in intravenous general anesthesia. This randomized control
      study will enroll patients receiving CT guided liver tumor radiofrequency ablation under
      general anesthesia. One group will receive high-flow nasal oxygen, the other group will
      receive traditional oxygen mask. The primary outcome is lung atelectasis area in CT scan. The
      secondary outcome is respiratory function (for example: arterial blood gas, lung injury
      biomarkers, saturation, postoperative pulmonary complication)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Chest CT image atelectatic area
time frame: At the end of surgery
description: lung atelectasis (-100 to +100 Hounsfield Unit) was calculated and as percent of the total area of the lung at the basal scan.
measure: postoperative pulmonary complications
time frame: within the first 7 days after surgery
description: postoperative pulmonary complications including pneumonia, pleural effusion, and acute lung injury.
measure: lung injury
time frame: At the end of surgery
description: lung injury biomarkers including Clara cell protein, Plasma neutrophil elastase.
measure: Respiratory gas exchange function
time frame: At the end of surgery
description: blood gas analysis including PaO2, PaCO2
measure: need for supplemental oxygen therapy
time frame: within the first 7 days after surgery
arm group label: high-flow nasal oxygen
arm group type: Experimental
description: high-flow nasal oxygen was used during intravenous general anesthesia
arm group label: Oxygen mask
arm group type: Active Comparator
description: oxygen mask was used during intravenous general anesthesia
intervention type: Device
intervention name: high-flow nasal oxygen
description: Using high-flow nasal oxygen 10 L/min before anesthesia induction, then using high-flow nasal oxygen 30-50 L/min during intravenous general anesthesia.
arm group label: high-flow nasal oxygen
other name: High-flow nasal cannula
intervention type: Device
intervention name: Oxygen mask
description: Using oxygen mask with oxygen flow 10 L/min before and during intravenous general anesthesia.
arm group label: Oxygen mask
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Chun-Yu Wu, MD,PhD
role: Principal Investigator
affiliation: National Taiwan University Hospital
last name: Chung-Chih Shih, MD
phone: +886 911674300
email: s6319138@gmail.com
last name: Chung-Chih Shih, MD
phone: +886 972653379
email: s6319138@hotmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Lung Injury
mesh term: Pulmonary Atelectasis
sharing ipd: No