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/NCT06006195</url>
    </required_header>
    <id_info>
      <org_study_id>202306130RINB</org_study_id>
      <nct_id>NCT06006195</nct_id>
    </id_info>
    <brief_title>Investigating the Correlations Between Dysphagia Symptoms and Swallowing Muscle Groups by HRPM-I</brief_title>
    <official_title>Investigating the Correlation Between Dysphagia Symptoms and Swallowing Muscle Groups by High-Resolution Pharyngeal Manometry With Impedance, Along With the Associated Nutritional Assessment</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Taiwan University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Taiwan University Hospital</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>
        Investigating the correlation between the dysphagia symptoms and swallowing muscle groups by&#xD;
        high resolution pharyngeal manometry with impedance&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Backgrounds: Some patients would experience dysphagia symptoms before the elective surgery.&#xD;
        These patients usually do not have a history of head and neck surgery or cerebrovascular&#xD;
        diseases. They are common causes of dysphagia. The anesthetics and airway manipulation can&#xD;
        exacerbate dysphagia. However, research is limited on the specific weak muscle groups in&#xD;
        patients with dysphagia symptoms, as well as on the existence of associated malnutrition.&#xD;
  &#xD;
        Aims: The Eating Assessment Tool (EAT-10) questionnaire will be used to assess dysphagia&#xD;
        symptoms. A score of ≥4 on the EAT-10 indicates the presence of dysphagia symptoms, while a&#xD;
        score of &lt;4 indicates the absence. This study aims to (1) investigate which specific muscle&#xD;
        groups are particularly weak in patients with dysphagia symptoms (EAT-10≥4); (2) to examine&#xD;
        whether patients with dysphagia symptoms (EAT-10≥4) have poorer nutritional status than&#xD;
        patients without dysphagia symptoms (EAT-10&lt;4).&#xD;
  &#xD;
        Methods: This is a cross-sectional study. The investigators will recruit patients undergoing&#xD;
        elective orthopedic surgery on the lower extremities, with the age range of 18 to 90 years.&#xD;
        On the day of admission, patients will be examined by the EAT-10 questionnaire for dysphagia&#xD;
        symptoms. High-resolution pharyngeal manometry with impedance will be conducted to measure&#xD;
        the functional of swallowing muscles. Additionally, patients will be given the Mini&#xD;
        Nutritional Assessment (MNA) questionnaire (a total score of 30 points). The higher scores&#xD;
        indicate the better nutritional status. The albumin level will also be collected. The&#xD;
        bioelectrical impedance analysis will be used to measure the patients' body composition,&#xD;
        specifically skeletal muscle mass.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 28, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2030</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2028</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>UES peak pressure, mmHg</measure>
      <time_frame>10 to 15 minutes</time_frame>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Swallowing Contraction Strength</condition>
    <arm_group>
      <arm_group_label>patients with dysphagia symptoms</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>patients without dysphagia symptoms</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>patients with dysphagia symptoms</intervention_name>
      <description>patients with dysphagia symptoms examined by high resolution impedance manometry</description>
      <arm_group_label>patients with dysphagia symptoms</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>patients without dysphagia symptoms</intervention_name>
      <description>patients without dysphagia symptoms examined by high resolution impedance manometry</description>
      <arm_group_label>patients without dysphagia symptoms</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          patients age from 20 to 80 years old without major organ dysfunction&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  age from 20 to 80 years&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  bleeding tendency&#xD;
  &#xD;
            -  pregnancy&#xD;
  &#xD;
            -  heart failure&#xD;
  &#xD;
            -  chronic kidney disease&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Chih-Min Liu, MD</last_name>
      <phone>_886-972652224</phone>
      <email>lewisliu@ntuh.gov.tw</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Chih-Jun Lai, MD</last_name>
      <phone>+886-972652086</phone>
      <email>littlecherrytw@gmail.com</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 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>National Taiwan University Hospital</investigator_affiliation>
      <investigator_full_name>National Taiwan University Clinical Trial Center</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Deglutition Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>due to ethical problem</ipd_description>
    </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/NCT06006195
  org study id: 202306130RINB
  nct id: NCT06006195
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Investigating the correlation between the dysphagia symptoms and swallowing muscle groups by
        high resolution pharyngeal manometry with impedance
  Backgrounds: Some patients would experience dysphagia symptoms before the elective surgery.
        These patients usually do not have a history of head and neck surgery or cerebrovascular
        diseases. They are common causes of dysphagia. The anesthetics and airway manipulation can
        exacerbate dysphagia. However, research is limited on the specific weak muscle groups in
        patients with dysphagia symptoms, as well as on the existence of associated malnutrition.
  
        Aims: The Eating Assessment Tool (EAT-10) questionnaire will be used to assess dysphagia
        symptoms. A score of ≥4 on the EAT-10 indicates the presence of dysphagia symptoms, while a
        score of <4 indicates the absence. This study aims to (1) investigate which specific muscle
        groups are particularly weak in patients with dysphagia symptoms (EAT-10≥4); (2) to examine
        whether patients with dysphagia symptoms (EAT-10≥4) have poorer nutritional status than
        patients without dysphagia symptoms (EAT-10<4).
  
        Methods: This is a cross-sectional study. The investigators will recruit patients undergoing
        elective orthopedic surgery on the lower extremities, with the age range of 18 to 90 years.
        On the day of admission, patients will be examined by the EAT-10 questionnaire for dysphagia
        symptoms. High-resolution pharyngeal manometry with impedance will be conducted to measure
        the functional of swallowing muscles. Additionally, patients will be given the Mini
        Nutritional Assessment (MNA) questionnaire (a total score of 30 points). The higher scores
        indicate the better nutritional status. The albumin level will also be collected. The
        bioelectrical impedance analysis will be used to measure the patients' body composition,
        specifically skeletal muscle mass.
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: UES peak pressure, mmHg
  time frame: 10 to 15 minutes
  arm group label: patients with dysphagia symptoms
  arm group label: patients without dysphagia symptoms
  intervention type: Other
  intervention name: patients with dysphagia symptoms
  description: patients with dysphagia symptoms examined by high resolution impedance manometry
  arm group label: patients with dysphagia symptoms
  intervention type: Other
  intervention name: patients without dysphagia symptoms
  description: patients without dysphagia symptoms examined by high resolution impedance manometry
  arm group label: patients without dysphagia symptoms
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Chih-Min Liu, MD
  phone: _886-972652224
  email: lewisliu@ntuh.gov.tw
  last name: Chih-Jun Lai, MD
  phone: +886-972652086
  email: littlecherrytw@gmail.com
  responsible party type: Principal Investigator
  investigator affiliation: National Taiwan University Hospital
  investigator full name: National Taiwan University Clinical Trial Center
  investigator title: Principal Investigator
  mesh term: Deglutition Disorders
  sharing ipd: No
  ipd description: due to ethical problem