<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/NCT04458220</url>
  </required_header>
  <id_info>
    <org_study_id>SH9H-2020-T233-1</org_study_id>
    <nct_id>NCT04458220</nct_id>
  </id_info>
  <brief_title>Research on Early Warning and Solution System of Difficult Airway in Perioperative Period Based on Artificial Intelligence</brief_title>
  <official_title>Research on Early Warning and Solution System of Difficult Airway in Perioperative Period Based on Artificial Intelligence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The study is performed in Shanghai Ninth People's Hospital Affiliated with Shanghai Jiao Tong&#xD;
      University School of Medicine . According to inclusion and exclusion criteria ,the&#xD;
      investigators are expected to enroll 16000 participants who performed endotracheal intubation&#xD;
      under general anesthesia. All enrolled participants must sign a written informed consent.In&#xD;
      the preset studio,The 3D face scanner and camera is used to obtain 3D or 2-dimensional&#xD;
      portrait images of patients in different positions and from different angles.The Hi-Fi&#xD;
      Recorder is used to obtain sound samples of patients in different word.Then,Statistical&#xD;
      experts use quantitative software to quantify the data.The investigators will put all the&#xD;
      data and images into a confidential database in order to build a large database of difficult&#xD;
      airways.&#xD;
&#xD;
      Anesthesiologist will give every patient an endotracheal intubation as planned. After that&#xD;
      the anesthesiologist will be asked to fill out the questionnaire immediately.This&#xD;
      questionnaire allows obtaining a ground truth for the intubation difficulty.All data will be&#xD;
      used for AI deep learning and intelligent analysis,Several of the most relevant landmarks&#xD;
      will be selected to build an early warning model.The overall study did not involve any&#xD;
      intervention in the process of anaesthesia and operation of the patients, only the&#xD;
      three-dimensional facial images of the patients were obtained, without any trauma or injury.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 30, 2020</start_date>
  <completion_date type="Anticipated">May 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">May 30, 2024</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnosed as a difficult airway</measure>
    <time_frame>Just after intubation</time_frame>
    <description>C-L≥Ⅲ grade</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difficult mask ventilation</measure>
    <time_frame>2 minutes after administration of Rocuronium</time_frame>
    <description>The difficult mask ventilation was defined as follows: (1) the inability of an unassisted anesthesiologist to maintain oxygen saturation, as measured by SpO2&lt;92% with 100% oxygen and positive-pressure mask ventilation; (2) significant gas flow leakage around the face mask; (3) the need to increase the gas flow to more than 15 L/min and use the oxygen flush valve more than twice (4) absence of visible chest movement; (5) the necessity to switch to a two-handed mask ventilation technique; (6) the need for operator substitution or addition.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">16000</enrollment>
  <condition>Difficult Airway</condition>
  <arm_group>
    <arm_group_label>difficult airway</arm_group_label>
    <description>C-L≥Ⅲ grade</description>
  </arm_group>
  <arm_group>
    <arm_group_label>none difficult airway</arm_group_label>
    <description>C-L&lt;Ⅲgrade</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>photo and voice obtained</intervention_name>
    <description>The 3D face scanner and camera is used to obtain 3D or 2-dimensional portrait images of patients in different positions and from different angles.The Hi-Fi Recorder is used to obtain sound samples of patients in different word.</description>
    <arm_group_label>difficult airway</arm_group_label>
    <arm_group_label>none difficult airway</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study is performed in Shanghai Ninth People's Hospital Affiliated with Shanghai Jiao&#xD;
        Tong University School of Medicine . According to inclusion and exclusion criteria ,We are&#xD;
        expected to enroll 16000 participants who performed endotracheal intubation under general&#xD;
        anesthesia.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients to be intubated under general anesthesia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with deaf-mutism or communication disorders.&#xD;
&#xD;
          -  Patients with language deficiency or non-native language.&#xD;
&#xD;
          -  Patients with mental or central nervous system disease.&#xD;
&#xD;
          -  Patients with stupefaction or disturbance of consciousness.&#xD;
&#xD;
          -  Patients with terrible injury.&#xD;
&#xD;
          -  Patients cannot follow instructions to perform standard actions.&#xD;
&#xD;
          -  Patients participated in other relevant clinical investigation in the past 3 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hong Jiang, Dr</last_name>
    <role>Study Chair</role>
    <affiliation>The Ninth People's Hospital of Shanghai Jiaotong University School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ren Zhou, Dr</last_name>
    <phone>86-15121007303</phone>
    <email>zhouren77@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ming Xia, Dr</last_name>
    <phone>86-15021306970</phone>
    <email>jianghongjiuyuan@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Ninth People's Hospital of Shanghai Jiaotong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ming xia, Dr</last_name>
      <phone>86-15021306970</phone>
      <email>jianghongjiuyuan@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 26, 2023</last_update_submitted>
  <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 12, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/20/NCT04458220/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04458220
org study id: SH9H-2020-T233-1
nct id: NCT04458220
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study is performed in Shanghai Ninth People's Hospital Affiliated with Shanghai Jiao Tong
      University School of Medicine . According to inclusion and exclusion criteria ,the
      investigators are expected to enroll 16000 participants who performed endotracheal intubation
      under general anesthesia. All enrolled participants must sign a written informed consent.In
      the preset studio,The 3D face scanner and camera is used to obtain 3D or 2-dimensional
      portrait images of patients in different positions and from different angles.The Hi-Fi
      Recorder is used to obtain sound samples of patients in different word.Then,Statistical
      experts use quantitative software to quantify the data.The investigators will put all the
      data and images into a confidential database in order to build a large database of difficult
      airways.

      Anesthesiologist will give every patient an endotracheal intubation as planned. After that
      the anesthesiologist will be asked to fill out the questionnaire immediately.This
      questionnaire allows obtaining a ground truth for the intubation difficulty.All data will be
      used for AI deep learning and intelligent analysis,Several of the most relevant landmarks
      will be selected to build an early warning model.The overall study did not involve any
      intervention in the process of anaesthesia and operation of the patients, only the
      three-dimensional facial images of the patients were obtained, without any trauma or injury.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Diagnosed as a difficult airway
time frame: Just after intubation
description: C-L≥Ⅲ grade
measure: Difficult mask ventilation
time frame: 2 minutes after administration of Rocuronium
description: The difficult mask ventilation was defined as follows: (1) the inability of an unassisted anesthesiologist to maintain oxygen saturation, as measured by SpO2<92% with 100% oxygen and positive-pressure mask ventilation; (2) significant gas flow leakage around the face mask; (3) the need to increase the gas flow to more than 15 L/min and use the oxygen flush valve more than twice (4) absence of visible chest movement; (5) the necessity to switch to a two-handed mask ventilation technique; (6) the need for operator substitution or addition.
arm group label: difficult airway
description: C-L≥Ⅲ grade
arm group label: none difficult airway
description: C-L<Ⅲgrade
intervention type: Other
intervention name: photo and voice obtained
description: The 3D face scanner and camera is used to obtain 3D or 2-dimensional portrait images of patients in different positions and from different angles.The Hi-Fi Recorder is used to obtain sound samples of patients in different word.
arm group label: difficult airway
arm group label: none difficult airway
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Hong Jiang, Dr
role: Study Chair
affiliation: The Ninth People's Hospital of Shanghai Jiaotong University School of Medicine
last name: Ren Zhou, Dr
phone: 86-15121007303
email: zhouren77@126.com
last name: Ming Xia, Dr
phone: 86-15021306970
email: jianghongjiuyuan@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
sharing ipd: No
provided document: 