<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/NCT04434963</url>
  </required_header>
  <id_info>
    <org_study_id>RenjiH6502</org_study_id>
    <nct_id>NCT04434963</nct_id>
  </id_info>
  <brief_title>Safety and Feasibility of Reversible Induction Strategy</brief_title>
  <official_title>Safety and Feasibility of Reversible Induction Strategy Supported by HFNC Combined With Specific Anesthetic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RenJi Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
      This study would explore the safety and feasibility of a reversible induction strategy for&#xD;
      uncertain difficult airway. This reversible induction strategy would include high flow nasal&#xD;
      canular oxygenation support, short-term effect anesthetic including Propofol and Remifentanil&#xD;
      for sedation and analgesia and Sugammadex would be used for reverse the muscle relaxant.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2021</start_date>
  <completion_date type="Anticipated">December 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Successful rate of reversion</measure>
    <time_frame>From the beginning of induction to 15min later</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>TOFr 0.9 reversion time</measure>
    <time_frame>From the beginning of induction to 15min later</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BIS 80 reversion time</measure>
    <time_frame>From the beginning of induction to 15min later</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tidal volume 6-8ml tidal volume 6-8ml/kg reversion time</measure>
    <time_frame>From the beginning of induction to 15min later</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>consciousness reversion time</measure>
    <time_frame>From the beginning of induction to 15min later</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Patients With Uncertain Difficult Airway</condition>
  <condition>Colon Cancer</condition>
  <condition>Gastric Cancer</condition>
  <condition>Prostatic Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with an uncertain difficult airway, who will undergo a selective operation and&#xD;
        need trachea intubtion.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;18 years old,&lt;65 years old&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
          -  Undergoing selective operation （ time of operation is over two hours）&#xD;
&#xD;
          -  ASA classification I-II&#xD;
&#xD;
          -  Mallampati classification 3-4&#xD;
&#xD;
          -  suspicious difficult airway, but the anesthetists decide to try to rapid induction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with several dysfunctions of liver, kidney or heart)&#xD;
&#xD;
          -  Patients with a full stomach or have other risk factors of reflux aspiration&#xD;
&#xD;
          -  Any medicine was taken before surgery, which might enhance or mitigate the effects of&#xD;
             muscle relaxant&#xD;
&#xD;
          -  Infection of the mouth or nose&#xD;
&#xD;
          -  Allergy history of any medicine which would be used in this study&#xD;
&#xD;
          -  Pregnant and lactating women&#xD;
&#xD;
          -  Patients with neuromuscular disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>diansan su</last_name>
    <role>Study Director</role>
    <affiliation>Renji Hospital, Shanghai Jiaotong University, Shanghai, China</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>diansan su</last_name>
    <phone>+862168383702</phone>
    <email>diansansu@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xiaoying Chi, M.S.</last_name>
    <phone>+86 18201706040</phone>
    <email>chixiaoying@renji.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200127</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>diansan su</last_name>
      <phone>+862168383702</phone>
      <email>diansansu@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>September 11, 2021</last_update_submitted>
  <last_update_submitted_qc>September 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 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>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>THRIVE</keyword>
  <keyword>Uncertain difficult airway</keyword>
  <keyword>Reversible induction strategy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>IPD is unavailable to other researchers</ipd_description>
  </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/NCT04434963
org study id: RenjiH6502
nct id: NCT04434963
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study would explore the safety and feasibility of a reversible induction strategy for
      uncertain difficult airway. This reversible induction strategy would include high flow nasal
      canular oxygenation support, short-term effect anesthetic including Propofol and Remifentanil
      for sedation and analgesia and Sugammadex would be used for reverse the muscle relaxant.
observational model: Case-Only
time perspective: Prospective
measure: Successful rate of reversion
time frame: From the beginning of induction to 15min later
measure: TOFr 0.9 reversion time
time frame: From the beginning of induction to 15min later
measure: BIS 80 reversion time
time frame: From the beginning of induction to 15min later
measure: Tidal volume 6-8ml tidal volume 6-8ml/kg reversion time
time frame: From the beginning of induction to 15min later
measure: consciousness reversion time
time frame: From the beginning of induction to 15min later
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: diansan su
role: Study Director
affiliation: Renji Hospital, Shanghai Jiaotong University, Shanghai, China
last name: diansan su
phone: +862168383702
email: diansansu@yahoo.com
last name: Xiaoying Chi, M.S.
phone: +86 18201706040
email: chixiaoying@renji.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: RenJi Hospital
investigator full name: diansan su
investigator title: Principal Investigator
mesh term: Prostatic Neoplasms
sharing ipd: No
ipd description: IPD is unavailable to other researchers