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/NCT05987293</url>
    </required_header>
    <id_info>
      <org_study_id>ChinaJapanFHAnesth</org_study_id>
      <nct_id>NCT05987293</nct_id>
    </id_info>
    <brief_title>A Single-center, Prospective Study for Mechanism and Risk Factors of Tracheal Tube-related Tongue Injury</brief_title>
    <official_title>Mechanism and Risk Factors of Tracheal Tube-related Tongue Injury</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>China-Japan Friendship Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>China-Japan Friendship 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>
        Article Summary&#xD;
  &#xD;
          1. Tracheal tube-related tongue injury is a common clinical complication that would lead to&#xD;
             serious events such as dysphagia, respiratory dysfuncion and macroglossia.&#xD;
  &#xD;
          2. There is a lack of qualitative and quantitative risk assessment of tracheal tube-related&#xD;
             tongue injury.&#xD;
  &#xD;
          3. This is a protocol of a single-center, prospective, paralled-group clinical trial based&#xD;
             on the measurement of dynamic changes in pressure between the tracheal tube and the&#xD;
             tongue in different position during the surgery.&#xD;
  &#xD;
          4. The primary endpoint is tracheal tube-related tongue injury, secondary outcomes include&#xD;
             the time to first successful recovery of oral intake of fluids and solid food and&#xD;
             airway-related events.&#xD;
  &#xD;
          5. This trial aims to find the best indicators for tracheal tracheal tube-related tongue&#xD;
             injury and to provide solid basis for optimizing airway protection strategies and&#xD;
             surgical positioning.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background Tracheal tube-related tongue injury can lead to post-intubation pharyngeal&#xD;
        dysfunction, postoperative macroglossia, or stridor after extubation. Possible mechanisms&#xD;
        include increased oral pressure, obstruction of venous and lymphatic return in the neck,&#xD;
        leading to severe throat pain, dysphagia, and respiratory function impairment. There is a&#xD;
        lack of indicators and clinical awareness of this issue. Therefore we have designed this&#xD;
        study to accurately monitor the tracheal tube-tongue pressure in different surgical position&#xD;
        during general anesthesia.&#xD;
  &#xD;
        Method This is a prospective, single-center observational study. Fifty-four patients&#xD;
        undergoing elective surgery in general anesthesia for more than 2 hours with endotracheal&#xD;
        tube applied will be enrolled. Patients will be divided into supine position (Supine group)&#xD;
        and the high-risk positions (Flexion group) groups. Dynamic changes in pressure between the&#xD;
        tracheal tube and the tongue are measured. All patients will be followed up until 7 days&#xD;
        after operation. Primary endpoint is tracheal tube-related tongue injury. Secondary outcomes&#xD;
        include the time to first successful recovery of oral intake of fluids and solid food, and&#xD;
        airway-related events.&#xD;
  &#xD;
        Discussion The study aims to explore the risk factors and pressure thresholds for tracheal&#xD;
        tracheal tube-related tongue injury.&#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 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2025</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>tracheal tube-related tongue injury</measure>
      <time_frame>Starting from the time after surgery till post-operative day 7 (POD7)</time_frame>
      <description>The primary composite endpoint is assessed as incidence of tracheal tube-related tongue injury, which is either the state of severe sore throat (VAS≥4), dysphagia after extubation, or any of the symptoms of macroglossia.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>time of first smooth water intake</measure>
      <time_frame>Starting from the time after surgery till post-operative day 7 (POD7)</time_frame>
      <description>time of first smooth water intake</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>time of first smooth solid food intake</measure>
      <time_frame>Starting from the time after surgery till post-operative day 7 (POD7)</time_frame>
      <description>time of first smooth solid food intake</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>airway related events</measure>
      <time_frame>Starting from the time after surgery till post-operative day 7 (POD7)</time_frame>
      <description>bronchospasm, aspiration, secondary intubation, respiratory tract infection, respiratory insufficiency, prolonged oxygen therapy, etc.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">54</enrollment>
    <condition>Tracheal Tube-related Tongue Injury</condition>
    <arm_group>
      <arm_group_label>Supine group</arm_group_label>
      <description>Fifty-four patients undergoing elective surgery in general anesthesia for more than 2 hours with endotracheal tube applied in China-Japan Friendship Hospital will be enrolled (See in Sample Size calculation). Patients will be divided into two groups according to the surgery: supine position (Supine group)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Flexion group</arm_group_label>
      <description>The high-risk positions (Flexion group) which include patients scheduled for surgery under the prone position, cervical traction position, and beach chair position.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Tracheal tube-tongue pressure is measured using a computerized occlusal analysis system based on T-Scan® technique, suitable for multi-point real-time monitoring of intraoral pressure.</intervention_name>
      <description>A flexible film sensor with a thickness of 0.11mm is placed between the tongue and the tracheal tube to measure the distribution, join force and dynamic changes of pressure at different site of the tongue. Five channels of pressure values will be recorded separately: (Ch1) the tip of the tongue, (Ch2) the middle of the tongue, (Ch3) the base of the tongue, (Ch4) the right side at the base of the tongue, (Ch5) the left side at the base of the tongue. The pressure values at the following points during the operation will be recorded: (t1) after intubation, (t2) highest pressure during patient positioning, (t3) after position fixed, (t4) at the end of surgery, (t5) before extubation.</description>
      <arm_group_label>Flexion group</arm_group_label>
      <arm_group_label>Supine group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Fifty-four patients undergoing elective surgery in general anesthesia for more than 2 hours&#xD;
          with endotracheal tube applied in China-Japan Friendship Hospital will be enrolled (See in&#xD;
          Sample Size calculation). Patients will be divided into two groups according to the&#xD;
          surgery: supine position (Supine group) and the high-risk positions (Flexion group) which&#xD;
          include the prone position, cervical traction position, and beach chair position. Patients&#xD;
          with existing oral or airway problems, or other factors influence postoperative recovery of&#xD;
          diet will be excluded.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. ASA I-III&#xD;
  &#xD;
            2. Age 18-85 years old&#xD;
  &#xD;
            3. Scheduled for elective surgery with tracheal intubation under general anesthesia, with&#xD;
               operation duration ≥2 hours&#xD;
  &#xD;
            4. The intended surgical position will be supine, prone, cervical traction or beach chair&#xD;
               position&#xD;
  &#xD;
            5. Obtained informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Informed consent is not obtained&#xD;
  &#xD;
            2. Maxillofacial surgeries or other surgeries involving the oral cavity and upper airway&#xD;
  &#xD;
            3. History of head and neck radiotherapy&#xD;
  &#xD;
            4. Deformity, trauma, infection and active bleeding exist in the mouth and tongue&#xD;
  &#xD;
            5. Airway hyperresponsiveness, active asthma, acute exacerbation of chronic obstructive&#xD;
               pulmonary disease, laryngeal osteomalacia&#xD;
  &#xD;
            6. Respiratory insufficiency, moderate to severe ventilation or diffusion dysfunction&#xD;
  &#xD;
            7. Existing chronic sore throat, recurrent laryngeal nerve injury, dysarthria, dysphagia,&#xD;
               severe gastroesophageal reflux, upper esophageal sphincter dysfunction, cardiac&#xD;
               stenosis and other basic diseases&#xD;
  &#xD;
            8. Postoperative total parenteral nutrition therapy is planned&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Wei Xia Li, MD</last_name>
      <role>Study Director</role>
      <affiliation>China-Japan Friendship Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Li Fang WANG, MD</last_name>
      <phone>+8615011393879</phone>
      <email>lilythewolf@sina.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Meng Tao ZHENG, MD</last_name>
      <phone>+8613671278389</phone>
      <email>dragon0303@sina.com</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>China-Japan Friendship Hospital</investigator_affiliation>
      <investigator_full_name>Li Fang Wang</investigator_full_name>
      <investigator_title>attending doctor</investigator_title>
    </responsible_party>
    <keyword>intubation</keyword>
    <keyword>general anesthesia</keyword>
    <keyword>endotracheal intubation</keyword>
    <keyword>post extubation dysphagia</keyword>
    <keyword>post extubation stridor</keyword>
    <keyword>tongue edema</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Wounds and Injuries</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Salicylic Acid</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The original data of this trial include Case Record Form (CRF) and electronic data capture (EDC). Informed consent forms with patients' signature will be stored in private database for clinical trial in the department of anesthesiology. Electronic information will be stored in authorized computer following clinical trial confidentiality. Patient records are available from GOODWILL Electronic Medical Record System (Version 6.0) with medical access only. Test data related to this trial will be uploaded to http://www.medresman.org.cn/ within 2 weeks after collection, available to be public.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>The original data of this trial include Case Record Form (CRF) and electronic data capture (EDC). Informed consent forms with patients' signature will be stored in private database for clinical trial in the department of anesthesiology. Electronic information will be stored in authorized computer following clinical trial confidentiality. Patient records are available from GOODWILL Electronic Medical Record System (Version 6.0) with medical access only. Test data related to this trial will be uploaded to http://www.medresman.org.cn/ within 2 weeks after collection, available to be public.</ipd_time_frame>
      <ipd_access_criteria>http://www.medresman.org.cn/</ipd_access_criteria>
    </patient_data>
    <!-- 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/NCT05987293
  org study id: ChinaJapanFHAnesth
  nct id: NCT05987293
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Article Summary
  
          1. Tracheal tube-related tongue injury is a common clinical complication that would lead to
             serious events such as dysphagia, respiratory dysfuncion and macroglossia.
  
          2. There is a lack of qualitative and quantitative risk assessment of tracheal tube-related
             tongue injury.
  
          3. This is a protocol of a single-center, prospective, paralled-group clinical trial based
             on the measurement of dynamic changes in pressure between the tracheal tube and the
             tongue in different position during the surgery.
  
          4. The primary endpoint is tracheal tube-related tongue injury, secondary outcomes include
             the time to first successful recovery of oral intake of fluids and solid food and
             airway-related events.
  
          5. This trial aims to find the best indicators for tracheal tracheal tube-related tongue
             injury and to provide solid basis for optimizing airway protection strategies and
             surgical positioning.
  Background Tracheal tube-related tongue injury can lead to post-intubation pharyngeal
        dysfunction, postoperative macroglossia, or stridor after extubation. Possible mechanisms
        include increased oral pressure, obstruction of venous and lymphatic return in the neck,
        leading to severe throat pain, dysphagia, and respiratory function impairment. There is a
        lack of indicators and clinical awareness of this issue. Therefore we have designed this
        study to accurately monitor the tracheal tube-tongue pressure in different surgical position
        during general anesthesia.
  
        Method This is a prospective, single-center observational study. Fifty-four patients
        undergoing elective surgery in general anesthesia for more than 2 hours with endotracheal
        tube applied will be enrolled. Patients will be divided into supine position (Supine group)
        and the high-risk positions (Flexion group) groups. Dynamic changes in pressure between the
        tracheal tube and the tongue are measured. All patients will be followed up until 7 days
        after operation. Primary endpoint is tracheal tube-related tongue injury. Secondary outcomes
        include the time to first successful recovery of oral intake of fluids and solid food, and
        airway-related events.
  
        Discussion The study aims to explore the risk factors and pressure thresholds for tracheal
        tracheal tube-related tongue injury.
  observational model: Cohort
  time perspective: Prospective
  measure: tracheal tube-related tongue injury
  time frame: Starting from the time after surgery till post-operative day 7 (POD7)
  description: The primary composite endpoint is assessed as incidence of tracheal tube-related tongue injury, which is either the state of severe sore throat (VAS≥4), dysphagia after extubation, or any of the symptoms of macroglossia.
  measure: time of first smooth water intake
  time frame: Starting from the time after surgery till post-operative day 7 (POD7)
  description: time of first smooth water intake
  measure: time of first smooth solid food intake
  time frame: Starting from the time after surgery till post-operative day 7 (POD7)
  description: time of first smooth solid food intake
  measure: airway related events
  time frame: Starting from the time after surgery till post-operative day 7 (POD7)
  description: bronchospasm, aspiration, secondary intubation, respiratory tract infection, respiratory insufficiency, prolonged oxygen therapy, etc.
  arm group label: Supine group
  description: Fifty-four patients undergoing elective surgery in general anesthesia for more than 2 hours with endotracheal tube applied in China-Japan Friendship Hospital will be enrolled (See in Sample Size calculation). Patients will be divided into two groups according to the surgery: supine position (Supine group)
  arm group label: Flexion group
  description: The high-risk positions (Flexion group) which include patients scheduled for surgery under the prone position, cervical traction position, and beach chair position.
  intervention type: Device
  intervention name: Tracheal tube-tongue pressure is measured using a computerized occlusal analysis system based on T-Scan® technique, suitable for multi-point real-time monitoring of intraoral pressure.
  description: A flexible film sensor with a thickness of 0.11mm is placed between the tongue and the tracheal tube to measure the distribution, join force and dynamic changes of pressure at different site of the tongue. Five channels of pressure values will be recorded separately: (Ch1) the tip of the tongue, (Ch2) the middle of the tongue, (Ch3) the base of the tongue, (Ch4) the right side at the base of the tongue, (Ch5) the left side at the base of the tongue. The pressure values at the following points during the operation will be recorded: (t1) after intubation, (t2) highest pressure during patient positioning, (t3) after position fixed, (t4) at the end of surgery, (t5) before extubation.
  arm group label: Flexion group
  arm group label: Supine group
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Wei Xia Li, MD
  role: Study Director
  affiliation: China-Japan Friendship Hospital
  last name: Li Fang WANG, MD
  phone: +8615011393879
  email: lilythewolf@sina.com
  last name: Meng Tao ZHENG, MD
  phone: +8613671278389
  email: dragon0303@sina.com
  responsible party type: Principal Investigator
  investigator affiliation: China-Japan Friendship Hospital
  investigator full name: Li Fang Wang
  investigator title: attending doctor
  mesh term: Wounds and Injuries
  mesh term: Salicylic Acid
  sharing ipd: Yes
  ipd description: The original data of this trial include Case Record Form (CRF) and electronic data capture (EDC). Informed consent forms with patients' signature will be stored in private database for clinical trial in the department of anesthesiology. Electronic information will be stored in authorized computer following clinical trial confidentiality. Patient records are available from GOODWILL Electronic Medical Record System (Version 6.0) with medical access only. Test data related to this trial will be uploaded to http://www.medresman.org.cn/ within 2 weeks after collection, available to be public.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: The original data of this trial include Case Record Form (CRF) and electronic data capture (EDC). Informed consent forms with patients' signature will be stored in private database for clinical trial in the department of anesthesiology. Electronic information will be stored in authorized computer following clinical trial confidentiality. Patient records are available from GOODWILL Electronic Medical Record System (Version 6.0) with medical access only. Test data related to this trial will be uploaded to http://www.medresman.org.cn/ within 2 weeks after collection, available to be public.
  ipd access criteria: http://www.medresman.org.cn/