<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/NCT03275428</url>
  </required_header>
  <id_info>
    <org_study_id>2017-07-002B</org_study_id>
    <nct_id>NCT03275428</nct_id>
  </id_info>
  <brief_title>THRIVE and Non-intubated Thoracic Surgery</brief_title>
  <official_title>Efficacy and Safety of Transnasal Humidified Rapid-insufflation Ventilator Exchange (THRIVE) and Non-intubated Thoracic Surgery (NITS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Veterans General Hospital, Taiwan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Veterans General Hospital, Taiwan</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>
      Video assisted thoracic surgery utilizes small instruments to perform complicated thoracic&#xD;
      surgeries. This minimally invasive technique leaves small wounds thus facilitate recovery.&#xD;
      Traditionally, thoracic surgery required general anesthesia with double lumen endobronchial&#xD;
      tube to facilitate one-lung ventilation. However, as anesthesia techniques improve, video&#xD;
      assisted thoracic surgery can be achieved with minimal sedation and without intubation.&#xD;
      Thoracic surgeries involve excision of lung tissue thus impair post-operative lung function,&#xD;
      putting patients at high risk of cardiopulmonary complications. Non-intubate thoracic&#xD;
      surgeries can avoid this complication by avoiding general anesthesia and intubation.&#xD;
&#xD;
      Transnasal humidified rapid-insufflation ventilator exchange offers 30-50 L/min oxygen via&#xD;
      nasal cannula, thus provide safe and comfortable way of oxygen supplementation. It is useful&#xD;
      in intravenous sedated patients since they are prone to hypoxia from respiratory suppression&#xD;
      and upper airway obstruction.&#xD;
&#xD;
      This study is a matched case-control study to compare the efficacy and safety of Transnasal&#xD;
      humidified rapid-insufflation ventilator exchange in non-intubated thoracic surgery versus&#xD;
      double lumen endobronchial tube intubated general anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lung cancer has been a leading cause of death for years. There are more than 10,000 new cases&#xD;
      in Taiwan. Delayed discovery of the disease is a reason for high mortality rate. Most cases&#xD;
      are discovered after second stage. Early discovery of the disease rely on low dose CT scans.&#xD;
      Early stage lung cancer patients are candidates for minimally invasive surgeries.&#xD;
      Traditionally thoracomies and video-assisted thoracic surgeries require general anesthesia&#xD;
      with double lumen endobronchial tubes. The technique of double lumen intubation and one lung&#xD;
      ventilation causes respiratory complications and damage to the trachea, larynx and vocal&#xD;
      cords. With the development of single port thoracotomies, anesthesia can be minimized as&#xD;
      well. Patients receive an epidural, intercostal or paravertebral nerve block to decrease&#xD;
      pain. Minimal anesthetic agents may be given to decrease anxiety or to induce light sedation.&#xD;
      Patients does not need to be intubated and can maintain respiratory function and can recover&#xD;
      quickly.&#xD;
&#xD;
      Not only can video-assisted thoracic surgery be used in lung tumor treatment, it can also be&#xD;
      used to threat esophageal and mediastinal lesions, pneumothorax or as a diagnostic tool.&#xD;
      Video-assisted thoracic surgery was shown to decrease acute phase inflammatory reactions,&#xD;
      decrease immunosuppression and can be beneficial for tumor treatment.&#xD;
&#xD;
      The intravenous sedation medications used in non-intubate thoracic surgery decrease pain and&#xD;
      anxiety. However, many will develop respiratory depression and upper airway obstruction.&#xD;
      Also, spontaneous pneumothorax during surgery causes one lung ventilation. Traditional oxygen&#xD;
      supply cannot meet the demand of non-intubated thoracic surgery. Transnasal humidified&#xD;
      rapid-insufflation ventilator exchange offers 30-70 L/min oxygen via nasal cannula. Its&#xD;
      humidified oxygen can decrease discomfort from cold dry gas. It also provides positive&#xD;
      pressure to the airway thus decrease airway obstruction.&#xD;
&#xD;
      Our hypothesis is that non-intubated thoracic surgery with transnasal humidified&#xD;
      rapid-insufflation ventilator exchange can maintain optimal surgical condition such as&#xD;
      maintain arterial oxygen pressure, decrease acute phase reactions, tumor suppression and&#xD;
      accelerate recovery after surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 11, 2017</start_date>
  <completion_date type="Anticipated">September 10, 2018</completion_date>
  <primary_completion_date type="Anticipated">September 10, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Arterial oxygen pressure</measure>
    <time_frame>From induction of anesthesia to surgical procedure to end of recovery room observation, duration of six hours.</time_frame>
    <description>Capability of maintaining arterial oxygen pressure &gt; 100 mmHg from arterial blood gas analysis before anesthetic induction, during surgery and in recovery room.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Arterial carbon dioxide pressure</measure>
    <time_frame>From induction of anesthesia to surgical procedure to end of recovery room observation, duration of six hours.</time_frame>
    <description>Capability of maintaining arterial carbon dioxide pressure &lt; 50 mmHg from arterial blood gas analysis before anesthetic induction, during surgery and in recovery room.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of stay</measure>
    <time_frame>From admission to ward to discharge from ward, duration of 5 days to two weeks.</time_frame>
    <description>Duration of stay as in days of admission in the hospital</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acute phase reaction</measure>
    <time_frame>From induction of anesthesia to surgical procedure to fifth post-operative day, duration of six days.</time_frame>
    <description>Measure of C-reactive protein from blood sample analysis before anesthetic induction, after tumor resection during surgery, on post-operative day 1, 3 and 5.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interleukins</measure>
    <time_frame>From induction of anesthesia to surgical procedure to fifth post-operative day, duration of six days.</time_frame>
    <description>Measure of interleukins from blood sample analysis before anesthetic induction, after tumor resection during surgery, on post-operative day 1, 3 and 5.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TNF</measure>
    <time_frame>From induction of anesthesia to surgical procedure to fifth post-operative day, duration of six days.</time_frame>
    <description>Measure of interleukins from blood sample analysis before anesthetic induction, after tumor resection during surgery,</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immune cell count</measure>
    <time_frame>From induction of anesthesia to surgical procedure to fifth post-operative day, duration of six days.</time_frame>
    <description>Measure of Immune cell count from blood sample analysis before anesthetic induction, after tumor resection during surgery,</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Thoracic Surgery</condition>
  <condition>Oxygenation</condition>
  <arm_group>
    <arm_group_label>THRIVE group</arm_group_label>
    <description>Patients receiving non-intubated thoracic surgery for lung nodule resections using intravenous sedation and transnasal humidified rapid-insufflation ventilator exchange</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Double lumen group</arm_group_label>
    <description>Patients receiving non-intubated thoracic surgery for lung nodule resections using general anesthesia and double lumen endobronchial tube</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>transnasal humidified rapid-insufflation ventilator exchange</intervention_name>
    <description>high flow nasal cannula with humidified oxygen</description>
    <arm_group_label>THRIVE group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with lung nodules requiring surgical resection&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Lung nodules requiring surgical resection&#xD;
&#xD;
          -  Resectable by video-assisted thoracic surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA class IV or V&#xD;
&#xD;
          -  Room air oxygen saturation by pulse oximeter &lt; 90%&#xD;
&#xD;
          -  Emergent surgery&#xD;
&#xD;
          -  Use of inotropics or vasoconstrictors&#xD;
&#xD;
          -  History of nasal surgery or cranial surgery&#xD;
&#xD;
          -  Abnormal coagulation profile&#xD;
&#xD;
          -  History of spinal surgery or trauma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chien-Kun Ting, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taipei Veterans General Hospital, Taiwan</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chien-Kun Ting, MD, PhD</last_name>
    <phone>+886-938593137</phone>
    <email>ckting@vghtpe.gov.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Anesthesiology, Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>112</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <contact>
      <last_name>Chien-Kun Ting, MD, PhD</last_name>
      <phone>+886938593137</phone>
      <email>ckting@vghtpe.gov.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>September 6, 2017</last_update_submitted>
  <last_update_submitted_qc>September 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>THRIVE</keyword>
  <keyword>Non-intubated thoracic surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Dissection</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/NCT03275428
org study id: 2017-07-002B
nct id: NCT03275428
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Video assisted thoracic surgery utilizes small instruments to perform complicated thoracic
      surgeries. This minimally invasive technique leaves small wounds thus facilitate recovery.
      Traditionally, thoracic surgery required general anesthesia with double lumen endobronchial
      tube to facilitate one-lung ventilation. However, as anesthesia techniques improve, video
      assisted thoracic surgery can be achieved with minimal sedation and without intubation.
      Thoracic surgeries involve excision of lung tissue thus impair post-operative lung function,
      putting patients at high risk of cardiopulmonary complications. Non-intubate thoracic
      surgeries can avoid this complication by avoiding general anesthesia and intubation.

      Transnasal humidified rapid-insufflation ventilator exchange offers 30-50 L/min oxygen via
      nasal cannula, thus provide safe and comfortable way of oxygen supplementation. It is useful
      in intravenous sedated patients since they are prone to hypoxia from respiratory suppression
      and upper airway obstruction.

      This study is a matched case-control study to compare the efficacy and safety of Transnasal
      humidified rapid-insufflation ventilator exchange in non-intubated thoracic surgery versus
      double lumen endobronchial tube intubated general anesthesia.
Lung cancer has been a leading cause of death for years. There are more than 10,000 new cases
      in Taiwan. Delayed discovery of the disease is a reason for high mortality rate. Most cases
      are discovered after second stage. Early discovery of the disease rely on low dose CT scans.
      Early stage lung cancer patients are candidates for minimally invasive surgeries.
      Traditionally thoracomies and video-assisted thoracic surgeries require general anesthesia
      with double lumen endobronchial tubes. The technique of double lumen intubation and one lung
      ventilation causes respiratory complications and damage to the trachea, larynx and vocal
      cords. With the development of single port thoracotomies, anesthesia can be minimized as
      well. Patients receive an epidural, intercostal or paravertebral nerve block to decrease
      pain. Minimal anesthetic agents may be given to decrease anxiety or to induce light sedation.
      Patients does not need to be intubated and can maintain respiratory function and can recover
      quickly.

      Not only can video-assisted thoracic surgery be used in lung tumor treatment, it can also be
      used to threat esophageal and mediastinal lesions, pneumothorax or as a diagnostic tool.
      Video-assisted thoracic surgery was shown to decrease acute phase inflammatory reactions,
      decrease immunosuppression and can be beneficial for tumor treatment.

      The intravenous sedation medications used in non-intubate thoracic surgery decrease pain and
      anxiety. However, many will develop respiratory depression and upper airway obstruction.
      Also, spontaneous pneumothorax during surgery causes one lung ventilation. Traditional oxygen
      supply cannot meet the demand of non-intubated thoracic surgery. Transnasal humidified
      rapid-insufflation ventilator exchange offers 30-70 L/min oxygen via nasal cannula. Its
      humidified oxygen can decrease discomfort from cold dry gas. It also provides positive
      pressure to the airway thus decrease airway obstruction.

      Our hypothesis is that non-intubated thoracic surgery with transnasal humidified
      rapid-insufflation ventilator exchange can maintain optimal surgical condition such as
      maintain arterial oxygen pressure, decrease acute phase reactions, tumor suppression and
      accelerate recovery after surgery.
observational model: Case-Control
time perspective: Prospective
measure: Arterial oxygen pressure
time frame: From induction of anesthesia to surgical procedure to end of recovery room observation, duration of six hours.
description: Capability of maintaining arterial oxygen pressure > 100 mmHg from arterial blood gas analysis before anesthetic induction, during surgery and in recovery room.
measure: Arterial carbon dioxide pressure
time frame: From induction of anesthesia to surgical procedure to end of recovery room observation, duration of six hours.
description: Capability of maintaining arterial carbon dioxide pressure < 50 mmHg from arterial blood gas analysis before anesthetic induction, during surgery and in recovery room.
measure: Duration of stay
time frame: From admission to ward to discharge from ward, duration of 5 days to two weeks.
description: Duration of stay as in days of admission in the hospital
measure: Acute phase reaction
time frame: From induction of anesthesia to surgical procedure to fifth post-operative day, duration of six days.
description: Measure of C-reactive protein from blood sample analysis before anesthetic induction, after tumor resection during surgery, on post-operative day 1, 3 and 5.
measure: Interleukins
time frame: From induction of anesthesia to surgical procedure to fifth post-operative day, duration of six days.
description: Measure of interleukins from blood sample analysis before anesthetic induction, after tumor resection during surgery, on post-operative day 1, 3 and 5.
measure: TNF
time frame: From induction of anesthesia to surgical procedure to fifth post-operative day, duration of six days.
description: Measure of interleukins from blood sample analysis before anesthetic induction, after tumor resection during surgery,
measure: Immune cell count
time frame: From induction of anesthesia to surgical procedure to fifth post-operative day, duration of six days.
description: Measure of Immune cell count from blood sample analysis before anesthetic induction, after tumor resection during surgery,
arm group label: THRIVE group
description: Patients receiving non-intubated thoracic surgery for lung nodule resections using intravenous sedation and transnasal humidified rapid-insufflation ventilator exchange
arm group label: Double lumen group
description: Patients receiving non-intubated thoracic surgery for lung nodule resections using general anesthesia and double lumen endobronchial tube
intervention type: Device
intervention name: transnasal humidified rapid-insufflation ventilator exchange
description: high flow nasal cannula with humidified oxygen
arm group label: THRIVE group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Chien-Kun Ting, MD, PhD
role: Principal Investigator
affiliation: Taipei Veterans General Hospital, Taiwan
last name: Chien-Kun Ting, MD, PhD
phone: +886-938593137
email: ckting@vghtpe.gov.tw
facility: 
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Aortic Dissection