<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/NCT04464317</url>
  </required_header>
  <id_info>
    <org_study_id>IRB202001240</org_study_id>
    <nct_id>NCT04464317</nct_id>
  </id_info>
  <brief_title>Dysphagia and Vocal Cord Injury Following Cardiac Surgery</brief_title>
  <official_title>Vocal Cord Impairment and Dysphagia in Cardiac Surgery</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>
      Aiming to determine the incidence and contributing risk factors of vocal fold mobility&#xD;
      impairment (VFMI) and dysphagia in postoperative cardiovascular patients and evaluate the&#xD;
      impact of VFMI on health-related outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a retrospective study to determine:&#xD;
&#xD;
        1. the incidence and contributing risk factors of vocal fold mobility impairment (VFMI) and&#xD;
           dysphagia in postoperative cardiovascular patients&#xD;
&#xD;
        2. evaluate the impact of VFMI on health-related outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Observational only, no subjects enrolled&#xD;
  </why_stopped>
  <start_date type="Actual">August 5, 2020</start_date>
  <completion_date type="Actual">June 13, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 13, 2023</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of vocal fold mobility impairment (VFMI) and dysphagia in postoperative cardiovascular patients</measure>
    <time_frame>January 2010-June 2020</time_frame>
    <description>Data analyses will be conducted using commercially available statistical software, SPSS and only de-identified data will be used during data analysis. We will pull data from the files in order to determine how often the patients have vocal fold mobility impairment and/or dysphagia following surgery.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Dysphagia</condition>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>Patient who has had cardiovascular surgery</arm_group_label>
    <description>Undergone an elective, urgent, and/or emergent cardiovascular surgery via endovascular or open (sternotomy and/or extended thoracotomy) technique at the University of Florida Health.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have undergone an elective, urgent, and/or emergent cardiovascular surgery via&#xD;
        endovascular or open (sternotomy and/or extended thoracotomy) technique at the University&#xD;
        of Florida Health.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All cardiac surgery patients January 2010-April 2020 at Shands Hospital&#xD;
&#xD;
          -  Patients aged between 18 and 90 years&#xD;
&#xD;
          -  Undergone an elective, urgent, and/or emergent cardiovascular surgery via endovascular&#xD;
             or open (sternotomy and/or extended thoracotomy) technique at the University of&#xD;
             Florida Health.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 18 years old or over 90 years old&#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>Eric Jeng, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>June 13, 2023</last_update_submitted>
  <last_update_submitted_qc>June 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deglutition Disorders</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>none at this time</ipd_description>
  </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/NCT04464317
org study id: IRB202001240
nct id: NCT04464317
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Aiming to determine the incidence and contributing risk factors of vocal fold mobility
      impairment (VFMI) and dysphagia in postoperative cardiovascular patients and evaluate the
      impact of VFMI on health-related outcomes.
This is a retrospective study to determine:

        1. the incidence and contributing risk factors of vocal fold mobility impairment (VFMI) and
           dysphagia in postoperative cardiovascular patients

        2. evaluate the impact of VFMI on health-related outcomes.
observational model: Cohort
time perspective: Retrospective
measure: Incidence of vocal fold mobility impairment (VFMI) and dysphagia in postoperative cardiovascular patients
time frame: January 2010-June 2020
description: Data analyses will be conducted using commercially available statistical software, SPSS and only de-identified data will be used during data analysis. We will pull data from the files in order to determine how often the patients have vocal fold mobility impairment and/or dysphagia following surgery.
arm group label: Patient who has had cardiovascular surgery
description: Undergone an elective, urgent, and/or emergent cardiovascular surgery via endovascular or open (sternotomy and/or extended thoracotomy) technique at the University of Florida Health.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Eric Jeng, MD
role: Principal Investigator
affiliation: University of Florida
country: United States
responsible party type: Sponsor
mesh term: Deglutition Disorders
mesh term: Cardiovascular Diseases
sharing ipd: No
ipd description: none at this time