<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/NCT04441970</url>
  </required_header>
  <id_info>
    <org_study_id>4-2020-0442</org_study_id>
    <nct_id>NCT04441970</nct_id>
  </id_info>
  <brief_title>The Influence of Head and Neck Position on the Cuff Pressure Using Nasotracheal Tube</brief_title>
  <official_title>The Influence of Head and Neck Position on the Cuff Pressure Using Nasotracheal Tube</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</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>
      Nasotracheal tube is a commonly used for securing airways when performing general anesthesia&#xD;
      in various oral and maxillofacial surgery such as tooth extraction, maxillary and mandibular&#xD;
      fractures. After the nasotracheal tube is placed in the patient's trachea, the process of&#xD;
      inflating the cuff at the end of the tube with air is required. If the cuff is inflated with&#xD;
      excess air, the cuff may press the mucous membrane on the inner wall of the trachea, causing&#xD;
      ischemia. Previous studies have shown that if the pressure in the cuff exceeds 30 cmH2O, it&#xD;
      is highly likely to cause ischemia. In addition, it was found that the pressure in the&#xD;
      excessively inflated cuff was associated with post-operative sore throat, vocal cord&#xD;
      paralysis, and nerve damage. Moreover, the pressure in the cuff may vary according to the&#xD;
      patient's head and neck posture. The pressure changes in the cuff may vary depending on the&#xD;
      material and shape of the cuff. Therefore, we will investigate to evaluate the effect of head&#xD;
      and neck posture on the pressure in the cuff of nasotracheal tube.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 24, 2020</start_date>
  <completion_date type="Anticipated">March 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>cuff pressure of the nasotracheal tube</measure>
    <time_frame>for 10 minutes after intubating the nasotracheal tube. At Day 0.</time_frame>
    <description>Cuff pressure will be measured in the various head and neck positions.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Adult Patients Over 20 Years of Age Who Require Intubation of the Nasotracheal Tube to Undergo Oral and Maxillofacial Surgery Under General Anesthesia</condition>
  <arm_group>
    <arm_group_label>Neutral position</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>General anesthesia will be induced and nasotracheal tube will be placed through the patient's nose. After 30 seconds, the cuff pressure will be measured using a cuff manometer. Inspiratory tidal volume, expiratory tidal volume, peak inspiratory pressure, and end-tidal carbon dioxide waveform will be recorded three times according to breathing. Whether ventilation is not adequate and air is leaking will be recorded.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Head extension position</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After changing the posture of the head and neck into head extension, cuff pressure will be recorded.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Head flexion position</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After changing the posture of the head and neck into head flexion, cuff pressure will be recorded.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Head rotation position</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After changing the posture of the head and neck into head rotation, cuff pressure will be recorded.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Neutral position</intervention_name>
    <description>The cuff pressure will be recorded at the neutral head position.</description>
    <arm_group_label>Neutral position</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Head extension position</intervention_name>
    <description>The cuff pressure will be recorded at the head extension position.</description>
    <arm_group_label>Head extension position</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Head flexion position</intervention_name>
    <description>The cuff pressure will be recorded at the head flexion position.</description>
    <arm_group_label>Head flexion position</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Head rotation position</intervention_name>
    <description>The cuff pressure will be recorded at the head rotation position.</description>
    <arm_group_label>Head rotation position</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients over 20 years of age&#xD;
&#xD;
          -  patients who require intubation of the nasotracheal tube to undergo oral and&#xD;
             maxillofacial surgery under general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients whose neck cannot be rotated due to cervical diseases, cervical fractures,&#xD;
             and previous cervical surgery&#xD;
&#xD;
          -  Patients undergoing emergency surgery&#xD;
&#xD;
          -  Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hyun Joo Kim</last_name>
    <role>Principal Investigator</role>
    <affiliation>Severance Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hyun Joo Kim</last_name>
    <phone>82-2-2224-1389</phone>
    <email>jjollong@yuhs.ac</email>
  </overall_contact>
  <location>
    <facility>
      <name>Yonsei Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hyun Joo Kim</last_name>
      <phone>82-2-2224-1389</phone>
      <email>jjollong@yuhs.ac</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>September 22, 2020</last_update_submitted>
  <last_update_submitted_qc>September 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04441970
org study id: 4-2020-0442
nct id: NCT04441970
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Nasotracheal tube is a commonly used for securing airways when performing general anesthesia
      in various oral and maxillofacial surgery such as tooth extraction, maxillary and mandibular
      fractures. After the nasotracheal tube is placed in the patient's trachea, the process of
      inflating the cuff at the end of the tube with air is required. If the cuff is inflated with
      excess air, the cuff may press the mucous membrane on the inner wall of the trachea, causing
      ischemia. Previous studies have shown that if the pressure in the cuff exceeds 30 cmH2O, it
      is highly likely to cause ischemia. In addition, it was found that the pressure in the
      excessively inflated cuff was associated with post-operative sore throat, vocal cord
      paralysis, and nerve damage. Moreover, the pressure in the cuff may vary according to the
      patient's head and neck posture. The pressure changes in the cuff may vary depending on the
      material and shape of the cuff. Therefore, we will investigate to evaluate the effect of head
      and neck posture on the pressure in the cuff of nasotracheal tube.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: Double (Participant, Care Provider)
measure: cuff pressure of the nasotracheal tube
time frame: for 10 minutes after intubating the nasotracheal tube. At Day 0.
description: Cuff pressure will be measured in the various head and neck positions.
arm group label: Neutral position
arm group type: Active Comparator
description: General anesthesia will be induced and nasotracheal tube will be placed through the patient's nose. After 30 seconds, the cuff pressure will be measured using a cuff manometer. Inspiratory tidal volume, expiratory tidal volume, peak inspiratory pressure, and end-tidal carbon dioxide waveform will be recorded three times according to breathing. Whether ventilation is not adequate and air is leaking will be recorded.
arm group label: Head extension position
arm group type: Experimental
description: After changing the posture of the head and neck into head extension, cuff pressure will be recorded.
arm group label: Head flexion position
arm group type: Experimental
description: After changing the posture of the head and neck into head flexion, cuff pressure will be recorded.
arm group label: Head rotation position
arm group type: Experimental
description: After changing the posture of the head and neck into head rotation, cuff pressure will be recorded.
intervention type: Procedure
intervention name: Neutral position
description: The cuff pressure will be recorded at the neutral head position.
arm group label: Neutral position
intervention type: Procedure
intervention name: Head extension position
description: The cuff pressure will be recorded at the head extension position.
arm group label: Head extension position
intervention type: Procedure
intervention name: Head flexion position
description: The cuff pressure will be recorded at the head flexion position.
arm group label: Head flexion position
intervention type: Procedure
intervention name: Head rotation position
description: The cuff pressure will be recorded at the head rotation position.
arm group label: Head rotation position
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Hyun Joo Kim
role: Principal Investigator
affiliation: Severance Hospital
last name: Hyun Joo Kim
phone: 82-2-2224-1389
email: jjollong@yuhs.ac
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor
sharing ipd: No