<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/NCT04506346</url>
  </required_header>
  <id_info>
    <org_study_id>XMLX201824</org_study_id>
    <nct_id>NCT04506346</nct_id>
  </id_info>
  <brief_title>Risk Prediction of Difficult Tracheal Intubation in OSAHS Patient</brief_title>
  <acronym>OSAHS</acronym>
  <official_title>Risk Prediction of Difficult Tracheal Intubation in Obstructive Sleep Apnea Hypopnea Syndrome Patient (OSAHS) Undergoing Uvulo-palato-pharyngoplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Tsinghua Chang Gung Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Tsinghua Chang Gung Hospital</source>
  <oversight_info>
    <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 evaluates the risk factors for difficult tracheal intubation in in obstructive&#xD;
      sleep apnea hypopnea syndrome(OSAHS) patients undergoing uvulo-palato-pharyngoplast(UPPP)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OSAHS patients are high risk group of difficult tracheal intubation. In clinical application,&#xD;
      unexpected difficult tracheal intubation is not rare. Difficult airway is a significant&#xD;
      problem to these patients and the physicans in terms of mortality and morbidity.&#xD;
&#xD;
      This study collects risk factors as physical examinations（including modified Mallampati&#xD;
      grade, neck circumference, lateral clinical craniofacial assessment and body mass index&#xD;
      ,BMI）, Stopbang scores, polysommographic parameters (including apnea-hypopnea index, AHI and&#xD;
      lowest SpO2, LSpO2), and special radiographic parameters in head and neck region. By using&#xD;
      statistics method, predictive model to manage risks would be established.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">September 30, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Difficult Tracheal Intubation</measure>
    <time_frame>1min After tracheal intubation</time_frame>
    <description>Grade Ⅲ or Ⅳ according to Cormach-Lehane Grading of laryngoscopic view</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Difficult Intubation</condition>
  <condition>Airway Obstruction</condition>
  <arm_group>
    <arm_group_label>OSAHS</arm_group_label>
    <description>patients with OSAHS, undergoing UPPP</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>difficult tracheal intubation</intervention_name>
    <description>Grade Ⅲ or Ⅳ according to Cormach-Lehane Grading of laryngoscopic view</description>
    <arm_group_label>OSAHS</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with moderate or severe obstructive sleep apnea hypopnea syndrome, which means&#xD;
        apnea-hypopnea index( AHI) &gt;15/h and lowest SpO2(LSpO2)&lt;85% in polysommographic test.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosed as OSAHS.&#xD;
&#xD;
          -  receive UPPP under general anesthesia in Beijing Tsinghua Changgung Hospital&#xD;
&#xD;
          -  ASA grade I or II&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA grade III or above&#xD;
&#xD;
          -  had received UPPP&#xD;
&#xD;
          -  had fore-teeth loosed&#xD;
&#xD;
          -  obstructive sleep apnea hypopnea were caused by hypothyroidism, acromegaly, or vocal&#xD;
             cord paralysis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Huan Zhang, MD</last_name>
    <role>Study Chair</role>
    <affiliation>department of anesthesia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>YAN SIYI</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>102218</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>February 1, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>August 6, 2020</last_update_submitted>
  <last_update_submitted_qc>August 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>airway management</keyword>
  <keyword>obstructive sleep apnea hypopnea syndrome</keyword>
  <keyword>risk predictive model</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Airway Obstruction</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/NCT04506346
org study id: XMLX201824
nct id: NCT04506346
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study evaluates the risk factors for difficult tracheal intubation in in obstructive
      sleep apnea hypopnea syndrome(OSAHS) patients undergoing uvulo-palato-pharyngoplast(UPPP)
OSAHS patients are high risk group of difficult tracheal intubation. In clinical application,
      unexpected difficult tracheal intubation is not rare. Difficult airway is a significant
      problem to these patients and the physicans in terms of mortality and morbidity.

      This study collects risk factors as physical examinations（including modified Mallampati
      grade, neck circumference, lateral clinical craniofacial assessment and body mass index
      ,BMI）, Stopbang scores, polysommographic parameters (including apnea-hypopnea index, AHI and
      lowest SpO2, LSpO2), and special radiographic parameters in head and neck region. By using
      statistics method, predictive model to manage risks would be established.
observational model: Ecologic or Community
time perspective: Cross-Sectional
measure: Difficult Tracheal Intubation
time frame: 1min After tracheal intubation
description: Grade Ⅲ or Ⅳ according to Cormach-Lehane Grading of laryngoscopic view
arm group label: OSAHS
description: patients with OSAHS, undergoing UPPP
intervention type: Diagnostic Test
intervention name: difficult tracheal intubation
description: Grade Ⅲ or Ⅳ according to Cormach-Lehane Grading of laryngoscopic view
arm group label: OSAHS
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Huan Zhang, MD
role: Study Chair
affiliation: department of anesthesia
facility: 
country: China
responsible party type: Sponsor
mesh term: Airway Obstruction
sharing ipd: No