<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/NCT03768739</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201802740</org_study_id>
    <nct_id>NCT03768739</nct_id>
  </id_info>
  <brief_title>Dysphagia and VFMI in Cardiac Patients</brief_title>
  <official_title>Dysphagia and Vocal Fold Mobility Impairment in Cardiac Surgical Patients</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 cardiothoracic surgical procedures. It also seeks&#xD;
      to 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 cardiac&#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 cardiac surgery. We therefore aimed to determine&#xD;
      the incidence of dysphagia and VFMI in this patient population and to characterize impairment&#xD;
      profiles related to swallowing safety and efficiency. We also aimed to assess the relative&#xD;
      impact of VFMI and dysphagia on health-related outcomes such as length of hospital stay,&#xD;
      pneumonia, sepsis, reintubation, and discharge status.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 3, 2019</start_date>
  <completion_date type="Actual">September 2, 2020</completion_date>
  <primary_completion_date type="Actual">September 2, 2020</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>
  <primary_outcome>
    <measure>Yale Residue Severity Rating Scale</measure>
    <time_frame>Baseline; Day 30</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>
  </primary_outcome>
  <primary_outcome>
    <measure>Vocal Fold Mobility Impairment</measure>
    <time_frame>Baseline</time_frame>
    <description>Index of left and right vocal fold movement</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">207</enrollment>
  <condition>Cardiac Disease</condition>
  <arm_group>
    <arm_group_label>CICU extubated 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 a flexible laryngoscope that contains a light source and video camera on the end through the open passages of your nose and to the back of the throat in order to visualize the swallowing mechanism.</description>
    <arm_group_label>CICU extubated patients</arm_group_label>
    <other_name>FEES</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        230 individuals undergoing cardiothoracic 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 cardiothoracic surgery via sternotomy and/or extended&#xD;
             thoracotomy requiring cardiopulmonary bypass&#xD;
&#xD;
          -  willing to participate in post-operative swallowing evaluation testing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing exclusively transcatheter valves&#xD;
&#xD;
          -  Patients undergoing exclusively thoracic endovascular aortic repair procedures&#xD;
&#xD;
          -  The inability to achieve appropriate alertness and cognitive status following&#xD;
             procedure will exclude one from completing the study.&#xD;
&#xD;
          -  Participants must pass cognition, respiratory and physical abilities screening to&#xD;
             ensure testing safety.&#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 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>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>
    <facility>
      <name>Thoracic and Cardiovasscular Surgery at UF Health</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>November 3, 2020</last_update_submitted>
  <last_update_submitted_qc>November 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dysphagia</keyword>
  <keyword>Extubation</keyword>
  <keyword>Cardiac Intensive Care Unit (CICU)</keyword>
  <keyword>Forced Expiratory Volume in One second (FEV1)</keyword>
  <keyword>Peak Expiratory Flow (PEF)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deglutition Disorders</mesh_term>
    <mesh_term>Heart 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/NCT03768739
org study id: IRB201802740
nct id: NCT03768739
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 cardiothoracic 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 cardiac
      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 cardiac surgery. We 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. We 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; Day 30
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: Index of left and right vocal fold movement
arm group label: CICU extubated 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 a flexible laryngoscope that contains a light source and video camera on the end through the open passages of your nose and to the back of the throat in order to visualize the swallowing mechanism.
arm group label: CICU extubated 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 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: Heart Diseases
sharing ipd: No