xml: <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/NCT06016998</url>
    </required_header>
    <id_info>
      <org_study_id>FACIAL-123</org_study_id>
      <nct_id>NCT06016998</nct_id>
    </id_info>
    <brief_title>Prediction Model of Hypoxemia in Gastrointestinal Endoscopy Sedation</brief_title>
    <official_title>Prediction Model of Hypoxemia in Gastrointestinal Endoscopy Based on Facial Photography and Clinical Indicators</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sichuan Provincial People's Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sichuan Provincial People's Hospital</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 incidence of hypoxemia during gastrointestinal endoscopy sedation is high, but there is&#xD;
        still a lack of perfect prediction model of hypoxemia, which often leads to unpredictable&#xD;
        respiratory complications. In order to ensure the safety of gastrointestinal endoscopy&#xD;
        sedation and make emergency plans in advance, a better diagnostic model is urgently needed to&#xD;
        help assess the risk of hypoxemia in patients undergoing the process and make early&#xD;
        intervention measures. Facial photography is a simple and feasible measure that can show the&#xD;
        facial soft tissue and structure of bone. The purpose of this study is to explore whether&#xD;
        facial photography combined with other clinical indicators can build a prediction model of&#xD;
        hypoxemia during gastrointestinal endoscopy sedation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Gastrointestinal endoscopy is an effective method for diagnosing gastrointestinal diseases.&#xD;
        There is a increasing number of patients undergo gastrointestinal examinations year by year.&#xD;
        Drug sedation can improve patient comfort and increase the intraoperative detection rate of&#xD;
        digestive disease. At present, the most commonly used medication for gastrointestinal&#xD;
        endoscopy sedation is propofol, which has a fast onset and short duration of time, making it&#xD;
        very suitable for sedation during outpatient short surgeries. However, propofol can cause&#xD;
        intraoperative hypoxemia. The hypoxemia is mainly caused by the respiratory inhibition of&#xD;
        propofol and upper airway obstruction after anesthesia. Hypoxemia caused by respiratory&#xD;
        inhibition can be optimized by adjusting the dose regimen. Hypoxemia caused by upper airway&#xD;
        collapse is more urgent and more difficult to deal with, and usually requires suspension of&#xD;
        gastroscopy and uses mask to ventilation , even needs undergo tracheal intubation. If&#xD;
        patients suffer from hypoxemia for a long time, it can lead to myocardial ischemia,&#xD;
        arrhythmia, permanent nerve injury, and even death and other serious complications.&#xD;
        Conventional airway assessment methods have poor prediction ability for airway abnormalities,&#xD;
        and imaging refined measurement indicators have good prediction ability, but their&#xD;
        implementation is difficult and difficult to promote. At present, there is still a lack of&#xD;
        accurate and simple prediction model for hypoxemia. It is still difficult to make a complete&#xD;
        early warning for intraoperative respiratory complications, and intraoperative hypoxemia&#xD;
        still occurs frequently. Therefore, in order to ensure the safety of gastrointestinal&#xD;
        endoscopy sedation and make emergency plans in advance, a more complete diagnostic model is&#xD;
        urgently needed to help assess the risk of hypoxemia in patients undergoing painless&#xD;
        gastrointestinal endoscopy surgery and make early interventions.&#xD;
  &#xD;
        Based on the above, the investigators assume that facial photography can provide a&#xD;
        comprehensive measurement of risk factors for craniofacial bone and soft tissue (obesity). A&#xD;
        prediction model constructed by combining facial photography measurement indicators with&#xD;
        other relevant indicators can easily and efficiently predict airway abnormalities. Therefore,&#xD;
        this study mainly explores the prediction model of craniofacial phenotype based on facial&#xD;
        photos and combined clinical indicators for hypoxemia after gastrointestinal anesthesia.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Measurement of facial features</measure>
      <time_frame>1 day During the process of anesthesia assessment</time_frame>
      <description>Measuring 50 sets of facial features through 5 facial photos</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>BMI</measure>
      <time_frame>1 day During the process of anesthesia assessment</time_frame>
      <description>Weight and height will be combined to report BMI in kg/m^2</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neck circumference</measure>
      <time_frame>1 day During the process of anesthesia assessment</time_frame>
      <description>Measure the neck circumference at the level of cricoid cartilage</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>waist circumference</measure>
      <time_frame>1 day During the process of anesthesia assessment</time_frame>
      <description>Measure waist circumference at navel level</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Modified Mallampati Score</measure>
      <time_frame>1 day During the process of anesthesia assessment</time_frame>
      <description>The patient is asked to sit upright, with the head in the center, the mouth as wide as possible, the tongue as far out as possible, no pronunciation is required, the pharyngeal structure is observed, and the observation is repeated twice to avoid false positives or false negatives.It is divided into four levels according to the structure of the pharynx.Higher level indicates difficulty in airway management.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Thyromental Distance</measure>
      <time_frame>1 day During the process of anesthesia assessment</time_frame>
      <description>Measure the distance from thyroid cartilage to the chin.If the distance is less than six centimeters, it indicates difficulty in airway management.</description>
    </other_outcome>
    <other_outcome>
      <measure>Upper lip bite test</measure>
      <time_frame>1 day During the process of anesthesia assessment</time_frame>
      <description>The patient is in a sitting position, with the lower jaw extending forward as much as possible and using the lower incisor to bite the lip line of the upper lip as much as possible. The level I lower incisor bites above the lip line of the upper lip; Level II lower incisors can bite below the red lip of the upper lip; Level III lower incisors cannot bite the upper lip.Higher level indicates difficulty in airway management.</description>
    </other_outcome>
    <other_outcome>
      <measure>interincisor gap</measure>
      <time_frame>1 day During the process of anesthesia assessment</time_frame>
      <description>Measure the distance between the upper and lower incisors .If the distance is less than three centimeters, it may indicate difficulty in airway management.</description>
    </other_outcome>
    <enrollment type="Anticipated">900</enrollment>
    <condition>Hypoxemia During Surgery</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients undergoing painless gastroscopy in Sichuan Provincial People's Hospital&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age ≥ 18 years old&#xD;
  &#xD;
            2. Patients undergoing painless gastroscopy&#xD;
  &#xD;
            3. The American Society of Anesthesiologists (ASA) grades I to III;&#xD;
  &#xD;
            4. The basic oxygenation SPO2 of the patient's breathing indoor air is ≥ 96%&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Have a history of symptomatic craniofacial abnormalities (such as Down syndrome)&#xD;
  &#xD;
            2. Previous history of craniofacial surgery&#xD;
  &#xD;
            3. There is too much facial hair, which clearly blurs the facial markings.&#xD;
  &#xD;
            4. Severe cardiopulmonary diseases such as myocardial infarction and bronchial asthma&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sichuan Provincial People's Hospital</investigator_affiliation>
      <investigator_full_name>Mengchang Yang</investigator_full_name>
      <investigator_title>Deputy Chief Physician</investigator_title>
    </responsible_party>
    <keyword>Hypoxemia</keyword>
    <keyword>Sedation</keyword>
    <keyword>Prediction</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypoxia</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06016998
  org study id: FACIAL-123
  nct id: NCT06016998
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The incidence of hypoxemia during gastrointestinal endoscopy sedation is high, but there is
        still a lack of perfect prediction model of hypoxemia, which often leads to unpredictable
        respiratory complications. In order to ensure the safety of gastrointestinal endoscopy
        sedation and make emergency plans in advance, a better diagnostic model is urgently needed to
        help assess the risk of hypoxemia in patients undergoing the process and make early
        intervention measures. Facial photography is a simple and feasible measure that can show the
        facial soft tissue and structure of bone. The purpose of this study is to explore whether
        facial photography combined with other clinical indicators can build a prediction model of
        hypoxemia during gastrointestinal endoscopy sedation.
  Gastrointestinal endoscopy is an effective method for diagnosing gastrointestinal diseases.
        There is a increasing number of patients undergo gastrointestinal examinations year by year.
        Drug sedation can improve patient comfort and increase the intraoperative detection rate of
        digestive disease. At present, the most commonly used medication for gastrointestinal
        endoscopy sedation is propofol, which has a fast onset and short duration of time, making it
        very suitable for sedation during outpatient short surgeries. However, propofol can cause
        intraoperative hypoxemia. The hypoxemia is mainly caused by the respiratory inhibition of
        propofol and upper airway obstruction after anesthesia. Hypoxemia caused by respiratory
        inhibition can be optimized by adjusting the dose regimen. Hypoxemia caused by upper airway
        collapse is more urgent and more difficult to deal with, and usually requires suspension of
        gastroscopy and uses mask to ventilation , even needs undergo tracheal intubation. If
        patients suffer from hypoxemia for a long time, it can lead to myocardial ischemia,
        arrhythmia, permanent nerve injury, and even death and other serious complications.
        Conventional airway assessment methods have poor prediction ability for airway abnormalities,
        and imaging refined measurement indicators have good prediction ability, but their
        implementation is difficult and difficult to promote. At present, there is still a lack of
        accurate and simple prediction model for hypoxemia. It is still difficult to make a complete
        early warning for intraoperative respiratory complications, and intraoperative hypoxemia
        still occurs frequently. Therefore, in order to ensure the safety of gastrointestinal
        endoscopy sedation and make emergency plans in advance, a more complete diagnostic model is
        urgently needed to help assess the risk of hypoxemia in patients undergoing painless
        gastrointestinal endoscopy surgery and make early interventions.
  
        Based on the above, the investigators assume that facial photography can provide a
        comprehensive measurement of risk factors for craniofacial bone and soft tissue (obesity). A
        prediction model constructed by combining facial photography measurement indicators with
        other relevant indicators can easily and efficiently predict airway abnormalities. Therefore,
        this study mainly explores the prediction model of craniofacial phenotype based on facial
        photos and combined clinical indicators for hypoxemia after gastrointestinal anesthesia.
  observational model: Cohort
  time perspective: Prospective
  measure: Measurement of facial features
  time frame: 1 day During the process of anesthesia assessment
  description: Measuring 50 sets of facial features through 5 facial photos
  measure: BMI
  time frame: 1 day During the process of anesthesia assessment
  description: Weight and height will be combined to report BMI in kg/m^2
  measure: Neck circumference
  time frame: 1 day During the process of anesthesia assessment
  description: Measure the neck circumference at the level of cricoid cartilage
  measure: waist circumference
  time frame: 1 day During the process of anesthesia assessment
  description: Measure waist circumference at navel level
  measure: Modified Mallampati Score
  time frame: 1 day During the process of anesthesia assessment
  description: The patient is asked to sit upright, with the head in the center, the mouth as wide as possible, the tongue as far out as possible, no pronunciation is required, the pharyngeal structure is observed, and the observation is repeated twice to avoid false positives or false negatives.It is divided into four levels according to the structure of the pharynx.Higher level indicates difficulty in airway management.
  measure: Thyromental Distance
  time frame: 1 day During the process of anesthesia assessment
  description: Measure the distance from thyroid cartilage to the chin.If the distance is less than six centimeters, it indicates difficulty in airway management.
  measure: Upper lip bite test
  time frame: 1 day During the process of anesthesia assessment
  description: The patient is in a sitting position, with the lower jaw extending forward as much as possible and using the lower incisor to bite the lip line of the upper lip as much as possible. The level I lower incisor bites above the lip line of the upper lip; Level II lower incisors can bite below the red lip of the upper lip; Level III lower incisors cannot bite the upper lip.Higher level indicates difficulty in airway management.
  measure: interincisor gap
  time frame: 1 day During the process of anesthesia assessment
  description: Measure the distance between the upper and lower incisors .If the distance is less than three centimeters, it may indicate difficulty in airway management.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Principal Investigator
  investigator affiliation: Sichuan Provincial People's Hospital
  investigator full name: Mengchang Yang
  investigator title: Deputy Chief Physician
  mesh term: Hypoxia