<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/NCT04459481</url>
  </required_header>
  <id_info>
    <org_study_id>PSH-2018-13</org_study_id>
    <nct_id>NCT04459481</nct_id>
  </id_info>
  <brief_title>Comparison of Two Bending Angles for Nasotracheal Intubation With a Malleable Vedio Stylet</brief_title>
  <official_title>Comparison of Two Bending Angles for Nasotracheal Intubation With a Malleable Vedio Stylet</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</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>
      Video intubating stylet can be safely and effectively used for nasotracheal intubation, but&#xD;
      the optimal bending angle is still unknown. In this study, the optimal bending angle will be&#xD;
      determined by comparing the intubation time and success rate of nasotracheal intubation with&#xD;
      video intubating stylet at two different bending angles.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      intubation will be accomplished at 70 bending angle and 90 degrees bending angle in each&#xD;
      group. intubation time, success rate, additional manoeuvres and epistaxis will be recorded&#xD;
      and compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 4, 2020</start_date>
  <completion_date type="Actual">November 5, 2020</completion_date>
  <primary_completion_date type="Actual">November 3, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Success rate of nasotracheal intubation</measure>
    <time_frame>Procedure (From the beginning of intubation to the end of intubation)</time_frame>
    <description>The percentage of successful nasotracheal intubation</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">98</enrollment>
  <condition>Intubation;Difficult</condition>
  <arm_group>
    <arm_group_label>70-degree bending angle group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intubation with a 70-degree bending angle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>90-degree bending angle group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intubation with a 90-degree bending angle</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>bending angle</intervention_name>
    <description>patients in 70-degree bending angle group are intubated with video stylet at 70-degree bending angle patients in 90-degree bending angle group are intubated with video stylet at 90-degree bending angle</description>
    <arm_group_label>70-degree bending angle group</arm_group_label>
    <arm_group_label>90-degree bending angle group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients require nasotracheal intubation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  fixed, or limited, neck movement, obstructive sleep apnoea, bilateral nasal&#xD;
             obstruction or patients with an abnormal coagulation status&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiaoming Deng, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese Academy of Medical Sciences and Peking Union Medical College</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ChineseAMS</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100144</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>January 13, 2021</last_update_submitted>
  <last_update_submitted_qc>January 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Juhui Liu</investigator_full_name>
    <investigator_title>Plastic Surgery Hospital</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Decompression Sickness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>March 3, 2021</submitted>
    <returned>March 26, 2021</returned>
    <submitted>March 4, 2022</submitted>
    <returned>May 17, 2022</returned>
  </pending_results>
  <!-- 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/NCT04459481
org study id: PSH-2018-13
nct id: NCT04459481
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Video intubating stylet can be safely and effectively used for nasotracheal intubation, but
      the optimal bending angle is still unknown. In this study, the optimal bending angle will be
      determined by comparing the intubation time and success rate of nasotracheal intubation with
      video intubating stylet at two different bending angles.
intubation will be accomplished at 70 bending angle and 90 degrees bending angle in each
      group. intubation time, success rate, additional manoeuvres and epistaxis will be recorded
      and compared.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Success rate of nasotracheal intubation
time frame: Procedure (From the beginning of intubation to the end of intubation)
description: The percentage of successful nasotracheal intubation
arm group label: 70-degree bending angle group
arm group type: Experimental
description: intubation with a 70-degree bending angle
arm group label: 90-degree bending angle group
arm group type: Experimental
description: intubation with a 90-degree bending angle
intervention type: Device
intervention name: bending angle
description: patients in 70-degree bending angle group are intubated with video stylet at 70-degree bending angle patients in 90-degree bending angle group are intubated with video stylet at 90-degree bending angle
arm group label: 70-degree bending angle group
arm group label: 90-degree bending angle group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Xiaoming Deng, MD
role: Principal Investigator
affiliation: Chinese Academy of Medical Sciences and Peking Union Medical College
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
investigator full name: Juhui Liu
investigator title: Plastic Surgery Hospital
mesh term: Decompression Sickness
sharing ipd: Yes
submitted: March 3, 2021
returned: March 26, 2021
submitted: March 4, 2022
returned: May 17, 2022