<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/NCT04471467</url>
  </required_header>
  <id_info>
    <org_study_id>PUs</org_study_id>
    <nct_id>NCT04471467</nct_id>
  </id_info>
  <brief_title>Effect of Tracheal Tube Fixation Method on Nasal Pressure of Patients With Nasal Tracheal Intubation</brief_title>
  <official_title>Effect of Tracheal Tube Fixation Method on Nasal Pressure of Patients With Nasal Tracheal Intubation</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Nasotracheal intubation (NTI) is commonly used in operations of the mouth, pharynx, larynx&#xD;
      and also the neck .Various complications can occur such as epistaxis,&#xD;
      bacteremia,turbinectomy, retropharyngeal dissection, and nasal alar pressure sores or&#xD;
      necrosis.In clinical practice, nasal pressure sores caused by NTI are not uncommon, but have&#xD;
      failed to attract clinical attention.The investigators have observed that the surgeon fixed&#xD;
      the nasal tracheal tube and threaded tube directly to the patient's head. The investigators&#xD;
      suspect that this method can reduce the pressure between the nasal tube and the nose.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nasotracheal intubation (NTI) is commonly used in operations of the mouth, pharynx, larynx&#xD;
      and also the neck .Various complications can occur such as epistaxis,&#xD;
      bacteremia,turbinectomy, retropharyngeal dissection, and nasal alar pressure sores or&#xD;
      necrosis.In clinical practice, nasal pressure sores caused by NTI are not uncommon, but have&#xD;
      failed to attract clinical attention.Oral and maxillofacial surgery usually uses nasal&#xD;
      endotracheal intubation to manage the airway. The tube fixation directly presses the skin of&#xD;
      the patient's nose. Due to the operation, the surgeon must stand on the head of the patient&#xD;
      and there is not enough space to place the tracheal tube bracket. Prolonged vascular&#xD;
      compression on the nasal region may be caused by excessive tension and angulation of the&#xD;
      nasotracheal tube against the nasal tissue.Studies have proposed the use of nasal packing,&#xD;
      hydrocolloidal dressing and modified nasal tracheal tube to reduce the direct contact between&#xD;
      the nasal tube and the nose, relieve the pressure between the two, so as to prevent the&#xD;
      occurrence of alar pressure ulcers, but there is no objective data to show the degree of&#xD;
      pressure reduction.In clinical practice, the investigatorshave observed surgeons fixed the&#xD;
      nasal endotracheal tube and threaded the tube directly to the patient's head. The&#xD;
      investigators suspect that this method can reduce the pressure between the nasal tube and the&#xD;
      nose, so the investigators want to use a pressure sensor to monitor the pressure between the&#xD;
      two.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 20, 2020</start_date>
  <completion_date type="Anticipated">December 20, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 20, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>pressure between the nasal tube and nose</measure>
    <time_frame>Immediately after procedure</time_frame>
    <description>pressure between the nasal tube and nose under different conditions</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">34</enrollment>
  <condition>Nasotracheal Intubation</condition>
  <arm_group>
    <arm_group_label>group F</arm_group_label>
    <description>Using tracheal tube fixation method （According to the needs of the surgery, the surgeon who did not participate in the trial）</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group N</arm_group_label>
    <description>No tracheal tube fixation （According to the needs of the surgery, the surgeon who did not participate in the trial）</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Fixed tracheal tube</intervention_name>
    <description>Tracheal tube fixation is determined by the surgeon according to the needs of the operation and is an independent process. Our research simply installed a monitoring device between the tube and the nose. The tube fixation takes place whether the observation of pressures is agreed to or not, as per standard protocol.</description>
    <arm_group_label>group F</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who will be receiving general anesthesia with nasal intubation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18-60 years old&#xD;
&#xD;
          -  ASA physical status I and II&#xD;
&#xD;
          -  Requiring general anesthesia with nasal intubation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous history of pressure ulcers&#xD;
&#xD;
          -  Nasal trauma or defect&#xD;
&#xD;
          -  The need for emergency surgery&#xD;
&#xD;
          -  Contraindications to nasal intubation&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yu Sun, MD,PhD</last_name>
    <phone>0086-136-1189-5542</phone>
    <email>dr_sunyu@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wenyue Hu, MM</last_name>
    <phone>0086-180-1918-0376</phone>
    <email>huwenyue08@163.com</email>
  </overall_contact_backup>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 12, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>July 18, 2020</last_update_submitted>
  <last_update_submitted_qc>July 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</investigator_affiliation>
    <investigator_full_name>Yu Sun</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>nasotracheal intubation</keyword>
  <keyword>Pressure Injury</keyword>
  <!-- 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/NCT04471467
org study id: PUs
nct id: NCT04471467
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Nasotracheal intubation (NTI) is commonly used in operations of the mouth, pharynx, larynx
      and also the neck .Various complications can occur such as epistaxis,
      bacteremia,turbinectomy, retropharyngeal dissection, and nasal alar pressure sores or
      necrosis.In clinical practice, nasal pressure sores caused by NTI are not uncommon, but have
      failed to attract clinical attention.The investigators have observed that the surgeon fixed
      the nasal tracheal tube and threaded tube directly to the patient's head. The investigators
      suspect that this method can reduce the pressure between the nasal tube and the nose.
Nasotracheal intubation (NTI) is commonly used in operations of the mouth, pharynx, larynx
      and also the neck .Various complications can occur such as epistaxis,
      bacteremia,turbinectomy, retropharyngeal dissection, and nasal alar pressure sores or
      necrosis.In clinical practice, nasal pressure sores caused by NTI are not uncommon, but have
      failed to attract clinical attention.Oral and maxillofacial surgery usually uses nasal
      endotracheal intubation to manage the airway. The tube fixation directly presses the skin of
      the patient's nose. Due to the operation, the surgeon must stand on the head of the patient
      and there is not enough space to place the tracheal tube bracket. Prolonged vascular
      compression on the nasal region may be caused by excessive tension and angulation of the
      nasotracheal tube against the nasal tissue.Studies have proposed the use of nasal packing,
      hydrocolloidal dressing and modified nasal tracheal tube to reduce the direct contact between
      the nasal tube and the nose, relieve the pressure between the two, so as to prevent the
      occurrence of alar pressure ulcers, but there is no objective data to show the degree of
      pressure reduction.In clinical practice, the investigatorshave observed surgeons fixed the
      nasal endotracheal tube and threaded the tube directly to the patient's head. The
      investigators suspect that this method can reduce the pressure between the nasal tube and the
      nose, so the investigators want to use a pressure sensor to monitor the pressure between the
      two.
observational model: Case-Only
time perspective: Prospective
measure: pressure between the nasal tube and nose
time frame: Immediately after procedure
description: pressure between the nasal tube and nose under different conditions
arm group label: group F
description: Using tracheal tube fixation method （According to the needs of the surgery, the surgeon who did not participate in the trial）
arm group label: group N
description: No tracheal tube fixation （According to the needs of the surgery, the surgeon who did not participate in the trial）
intervention type: Procedure
intervention name: Fixed tracheal tube
description: Tracheal tube fixation is determined by the surgeon according to the needs of the operation and is an independent process. Our research simply installed a monitoring device between the tube and the nose. The tube fixation takes place whether the observation of pressures is agreed to or not, as per standard protocol.
arm group label: group F
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Yu Sun, MD,PhD
phone: 0086-136-1189-5542
email: dr_sunyu@163.com
last name: Wenyue Hu, MM
phone: 0086-180-1918-0376
email: huwenyue08@163.com
responsible party type: Principal Investigator
investigator affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
investigator full name: Yu Sun
investigator title: Principal Investigator