<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/NCT04487028</url>
  </required_header>
  <id_info>
    <org_study_id>IRB202000724-A</org_study_id>
    <nct_id>NCT04487028</nct_id>
  </id_info>
  <brief_title>Dysphagia in Thoracic Surgical Patients</brief_title>
  <official_title>Dysphagia in Thoracic Surgical Patients: Incidence, Risk-factors, and Health Related Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florida</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>
      The proposed study seeks to determine the incidence of dysphagia and vocal fold mobility&#xD;
      impairment (VFMI) in individuals undergoing throacic surgical procedures. It also seeks to&#xD;
      determine the impact of postoperative swallowing impairment on health-related outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Swallowing impairment and VFMI are common, yet often overlooked, complications of thoracic&#xD;
      surgical procedures. The true incidence of both dysphagia and VFMI in this patient population&#xD;
      is unclear due to a lack of rigorous study using instrumental assessment techniques and&#xD;
      validated outcomes in all patents undergoing thoracic surgery. The study is therefore aimed&#xD;
      to determine the incidence of dysphagia and VFMI in this patient population and to&#xD;
      characterize impairment profiles related to swallowing safety and efficiency. In addition,&#xD;
      the study is also aimed to assess the relative impact of VFMI and dysphagia on health-related&#xD;
      outcomes such as length of hospital stay, pneumonia, sepsis, reintubation, and discharge&#xD;
      status&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 25, 2020</start_date>
  <completion_date type="Actual">November 22, 2021</completion_date>
  <primary_completion_date type="Actual">August 13, 2021</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>Penetration Aspiration Scale</measure>
    <time_frame>Baseline</time_frame>
    <description>This scale is a validated measure used by trained blinded clinicians to assign ratings of safety to swallowing bolus trials. The development and use of an 8-point, equal-appearing interval scale (8 being best; 1 being worst) to describe penetration and aspiration events are described. Scores are determined primarily by the depth to which material passes in the airway and by whether or not material entering the airway is expelled.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Yale Residue Severity Rating Scale</measure>
    <time_frame>Baseline</time_frame>
    <description>This scale is a validated measure used by trained blinded clinicians to assign ratings of efficiency to swallowing bolus trials. The Yale Pharyngeal Residue Severity Rating Scale was developed, standardized, and validated to provide reliable, anatomically defined, and image-based assessment of post-swallow pharyngeal residue severity as observed during fiberoptic endoscopic evaluation of swallowing (FEES). It is a five-point ordinal rating scale based on residue location (vallecula and pyriform sinus) and amount (none, trace, mild, moderate, and severe).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Vocal Fold Mobility Impairment</measure>
    <time_frame>Baseline</time_frame>
    <description>During a Fiberoptic Endoscopic Evaluation of Swallowing (FEES), the vocal folds will be visualized using a small camera passed through the open nasal passage. The patient will be asked to make a series of vocal tasks so that we can visualize their movement, any immobility will be notated.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">61</enrollment>
  <condition>Thoracic Diseases</condition>
  <arm_group>
    <arm_group_label>Thoracic Surgical Patients</arm_group_label>
    <description>Participants will undergo a Fiberoptic Endoscopic Evaluation of Swallowing (FEES)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Fiberoptic Endoscopic Evaluation of Swallowing</intervention_name>
    <description>This procedure involves inserting a flexible laryngoscope that contains a light source and video camera on the end through the open passage of the nose towards the back of the throat in order to visualize the swallowing mechanism.</description>
    <arm_group_label>Thoracic Surgical Patients</arm_group_label>
    <other_name>FEES</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        240 individuals undergoing thoracic surgery will be enrolled in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adults aged 18 - 90 years old&#xD;
&#xD;
          -  undergoing planned or emergent thoracic surgery via clamshell and/or extended&#xD;
             thoracotomy&#xD;
&#xD;
          -  confirmed negative COVID-19 test&#xD;
&#xD;
          -  willing to participate in postoperative swallowing evaluation testing.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  individuals under the age of 18.&#xD;
&#xD;
          -  pregnant&#xD;
&#xD;
          -  or those testing positive for COVID-19&#xD;
&#xD;
          -  Additionally, the inability to demonstrate appropriate alertness and cognitive status&#xD;
             following the procedure will exclude a participant from participating in this study to&#xD;
             ensure protection of vulnerable individuals.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emily K Plowman, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cardiovascular Clinic at UF Health UF</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thoracic and Cardiovasscular Surgery at UF Health</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UF Health at the University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>November 23, 2021</last_update_submitted>
  <last_update_submitted_qc>November 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dysphagia</keyword>
  <keyword>Extubation</keyword>
  <keyword>Vocal Fold Mobility Impairment</keyword>
  <keyword>Peak Cough Flow (PCF)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deglutition Disorders</mesh_term>
    <mesh_term>Thoracic Diseases</mesh_term>
  </condition_browse>
  <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/NCT04487028
org study id: IRB202000724-A
nct id: NCT04487028
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The proposed study seeks to determine the incidence of dysphagia and vocal fold mobility
      impairment (VFMI) in individuals undergoing throacic surgical procedures. It also seeks to
      determine the impact of postoperative swallowing impairment on health-related outcomes.
Swallowing impairment and VFMI are common, yet often overlooked, complications of thoracic
      surgical procedures. The true incidence of both dysphagia and VFMI in this patient population
      is unclear due to a lack of rigorous study using instrumental assessment techniques and
      validated outcomes in all patents undergoing thoracic surgery. The study is therefore aimed
      to determine the incidence of dysphagia and VFMI in this patient population and to
      characterize impairment profiles related to swallowing safety and efficiency. In addition,
      the study is also aimed to assess the relative impact of VFMI and dysphagia on health-related
      outcomes such as length of hospital stay, pneumonia, sepsis, reintubation, and discharge
      status
observational model: Cohort
time perspective: Prospective
measure: Penetration Aspiration Scale
time frame: Baseline
description: This scale is a validated measure used by trained blinded clinicians to assign ratings of safety to swallowing bolus trials. The development and use of an 8-point, equal-appearing interval scale (8 being best; 1 being worst) to describe penetration and aspiration events are described. Scores are determined primarily by the depth to which material passes in the airway and by whether or not material entering the airway is expelled.
measure: Yale Residue Severity Rating Scale
time frame: Baseline
description: This scale is a validated measure used by trained blinded clinicians to assign ratings of efficiency to swallowing bolus trials. The Yale Pharyngeal Residue Severity Rating Scale was developed, standardized, and validated to provide reliable, anatomically defined, and image-based assessment of post-swallow pharyngeal residue severity as observed during fiberoptic endoscopic evaluation of swallowing (FEES). It is a five-point ordinal rating scale based on residue location (vallecula and pyriform sinus) and amount (none, trace, mild, moderate, and severe).
measure: Vocal Fold Mobility Impairment
time frame: Baseline
description: During a Fiberoptic Endoscopic Evaluation of Swallowing (FEES), the vocal folds will be visualized using a small camera passed through the open nasal passage. The patient will be asked to make a series of vocal tasks so that we can visualize their movement, any immobility will be notated.
arm group label: Thoracic Surgical Patients
description: Participants will undergo a Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
intervention type: Procedure
intervention name: Fiberoptic Endoscopic Evaluation of Swallowing
description: This procedure involves inserting a flexible laryngoscope that contains a light source and video camera on the end through the open passage of the nose towards the back of the throat in order to visualize the swallowing mechanism.
arm group label: Thoracic Surgical Patients
other name: FEES
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Emily K Plowman, PhD
role: Principal Investigator
affiliation: University of Florida
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Deglutition Disorders
mesh term: Thoracic Diseases
sharing ipd: No