<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/NCT04496986</url>
  </required_header>
  <id_info>
    <org_study_id>IRB202001367</org_study_id>
    <secondary_id>OCR39324</secondary_id>
    <nct_id>NCT04496986</nct_id>
  </id_info>
  <brief_title>Dysphagia in Cardiac Surgical Patients_</brief_title>
  <official_title>Mechanisms, Predictors and Clinical Markers of Dysphagia 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 cardiovascular 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&#xD;
      cardiovascular surgical procedures. The true incidence of both dysphagia and VFMI in this&#xD;
      patient population is unclear due to a lack of rigorous study using instrumental assessment&#xD;
      techniques and validated outcomes in all patients undergoing cardiovascular surgery. The&#xD;
      study is therefore aimed to determine the incidence of dysphagia and VFMI in this patient&#xD;
      population and to characterize impairment profiles related to swallowing safety and&#xD;
      efficiency. In addition, the study is also aimed to assess the relative impact of VFMI and&#xD;
      dysphagia on health-related outcomes such as length of hospital stay, pneumonia, sepsis,&#xD;
      reintubation, and discharge status. We will identify risk factors for postoperative dysphagia&#xD;
      and VFMI in cardiovascular patients to build a practical electronic risk-stratification tool.&#xD;
      We also aim to identify sensitive bedside clinical markers of dysphagia in postoperative&#xD;
      cardiovascular patients to develop a bedside screening tool. All participants will undergo&#xD;
      two research visits (one preoperatively and one postoperatively) where they will undergo an&#xD;
      instrumental swallowing test and complete several patient report outcomes and clinical tests.&#xD;
      If they are found to have dysphagia after surgery, they will be offered no-cost follow up&#xD;
      swallow tests at months 1 and 6. Finally, health-related outcomes will be indexed in enrolled&#xD;
      participants to determine the impact of dysphagia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    This study was replaced by a new study given recent funding by the NIH.&#xD;
  </why_stopped>
  <start_date type="Anticipated">May 2022</start_date>
  <completion_date type="Anticipated">December 31, 2026</completion_date>
  <primary_completion_date type="Anticipated">September 1, 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>Penetration Aspiration Scale</measure>
    <time_frame>Baseline (Prior to surgery)</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. (FEES)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Penetration Aspiration Scale</measure>
    <time_frame>Follow-up - Within 72 hours following extubation from surgery and onward</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. (Used in both FEES and VFSS)</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>Cardiovascular Surgical Patients Preoperative Exam</arm_group_label>
    <description>All enrolled participants will undergo a baseline Fiberoptic Endoscopic Evaluation of Swallowing (FEES) before their surgery to determine baseline / preoperative swallowing function. Those with confirmed dysphagia will not be asked to complete the postoperative swallowing exam, given our desire to examine contributing risk factors for dysphagia development and mechanisms within cardiovascular surgical patients. In addition to the instrumental exam, systematic collection of demographic, medical, surgical, and intubation-related candidate predictor variables will be conducted over the entire perioperative period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cardiovascular Surgical Patients Postoperative Exam</arm_group_label>
    <description>All remaining participants without preoperative dysphagia will be seen for a postoperative exam performed within 48 hours of extubation. Simultaneous imaging using FEES and videofluoroscopy will be performed at the bedside, as well as a battery of clinical tests. Completion of these postoperative tests will indicate study completion for participants without evidence of dysphagia, while participants who demonstrate acute-phase postoperative dysphagia will continue to participate if they desire. During their standard of care one-month follow-up appointment, a third research evaluation will be offered for participants with previously identified postoperative dysphagia. During this exam, the same imaging and clinical tests from the previous research exam will be performed. Finally, participants with persisting dysphagia will be offered the opportunity to continue to be studied for a fourth and final research exam during their standard of care six-month follow up clinic visit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</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>Cardiovascular Surgical Patients Postoperative Exam</arm_group_label>
    <arm_group_label>Cardiovascular Surgical Patients Preoperative Exam</arm_group_label>
    <other_name>FEES</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Simultaneous FEES and Videofluoroscopy instrumental swallowing exam</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. The participant will be asked to perform some voicing tasks, once completed, a videofluoroscopic swallowing exam will occur at the same time. This is like moving x-ray of the participant swallowing foods and liquids (barium).</description>
    <arm_group_label>Cardiovascular Surgical Patients Postoperative Exam</arm_group_label>
    <other_name>Endofluoroscopy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Voluntary Cough Peak Expiratory Flow (PEF) Testing</intervention_name>
    <description>Cough PEF will be performed to index a participant's physiologic airway defense capacity and strength. Testing will occur with the participant seated upright at 90 degrees using an analog peak flow meter with a one-way expiratory valve that prevents a participant from breathing air in from the device to reduce contamination.</description>
    <arm_group_label>Cardiovascular Surgical Patients Postoperative Exam</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Reflex Cough Screen</intervention_name>
    <description>Participants will be seated upright and administered reflex cough testing via a disposable adult aerosol mask with an attached nebulizer that contains a solution to elicit a cough response.</description>
    <arm_group_label>Cardiovascular Surgical Patients Postoperative Exam</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Lingual Pressure Testing</intervention_name>
    <description>Lingual strength will be evaluated using the Iowa Oral Pressure Instrument (IOPI). Participants will be seated upright, and the SLP will place the IOPI air-filled sensing bulb in the midline anterior position on the participant's tongue, posterior to the alveolar ridge.</description>
    <arm_group_label>Cardiovascular Surgical Patients Postoperative Exam</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Speech Testing</intervention_name>
    <description>Speech assessment will occur with the participant comfortably seated headset microphone with a lapel windscreen connected to a TASCAM DR40 to allow for high-quality audio recordings. Individuals will be asked to perform two maximal performance speech tasks that include vowel prolongation of /a/, and a Diadochokinetic (DDK) rate task to examine SMR for production of the word &quot;buttercup.&quot;</description>
    <arm_group_label>Cardiovascular Surgical Patients Postoperative Exam</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        360 individuals undergoing cardiac surgery will be enrolled in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: 1) individuals over 18 years of age, 2) undergoing a cardiovascular&#xD;
        procedure at the University of Florida Heart and Vascular Hospital, 3) confirmed negative&#xD;
        COVID-19 test result, 4) no allergies to barium, 5) not pregnant (female participants), and&#xD;
        6) willing to participate in research exams.&#xD;
&#xD;
        Exclusion Criteria: 1) individuals under the age of 18, 2) patients with a confirmed&#xD;
        positive COVID-19 test result, 3) participants with allergies to barium, 4) pregnant women,&#xD;
        or 5) unwilling to participate in research exams.&#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>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>May 19, 2022</last_update_submitted>
  <last_update_submitted_qc>May 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2022</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>Cardiovascular 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/NCT04496986
org study id: IRB202001367
secondary id: OCR39324
nct id: NCT04496986
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 cardiovascular 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
      cardiovascular 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 patients undergoing cardiovascular 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. We will identify risk factors for postoperative dysphagia
      and VFMI in cardiovascular patients to build a practical electronic risk-stratification tool.
      We also aim to identify sensitive bedside clinical markers of dysphagia in postoperative
      cardiovascular patients to develop a bedside screening tool. All participants will undergo
      two research visits (one preoperatively and one postoperatively) where they will undergo an
      instrumental swallowing test and complete several patient report outcomes and clinical tests.
      If they are found to have dysphagia after surgery, they will be offered no-cost follow up
      swallow tests at months 1 and 6. Finally, health-related outcomes will be indexed in enrolled
      participants to determine the impact of dysphagia.
observational model: Cohort
time perspective: Prospective
measure: Penetration Aspiration Scale
time frame: Baseline (Prior to surgery)
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. (FEES)
measure: Penetration Aspiration Scale
time frame: Follow-up - Within 72 hours following extubation from surgery and onward
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. (Used in both FEES and VFSS)
arm group label: Cardiovascular Surgical Patients Preoperative Exam
description: All enrolled participants will undergo a baseline Fiberoptic Endoscopic Evaluation of Swallowing (FEES) before their surgery to determine baseline / preoperative swallowing function. Those with confirmed dysphagia will not be asked to complete the postoperative swallowing exam, given our desire to examine contributing risk factors for dysphagia development and mechanisms within cardiovascular surgical patients. In addition to the instrumental exam, systematic collection of demographic, medical, surgical, and intubation-related candidate predictor variables will be conducted over the entire perioperative period.
arm group label: Cardiovascular Surgical Patients Postoperative Exam
description: All remaining participants without preoperative dysphagia will be seen for a postoperative exam performed within 48 hours of extubation. Simultaneous imaging using FEES and videofluoroscopy will be performed at the bedside, as well as a battery of clinical tests. Completion of these postoperative tests will indicate study completion for participants without evidence of dysphagia, while participants who demonstrate acute-phase postoperative dysphagia will continue to participate if they desire. During their standard of care one-month follow-up appointment, a third research evaluation will be offered for participants with previously identified postoperative dysphagia. During this exam, the same imaging and clinical tests from the previous research exam will be performed. Finally, participants with persisting dysphagia will be offered the opportunity to continue to be studied for a fourth and final research exam during their standard of care six-month follow up clinic visit.
intervention type: Diagnostic Test
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: Cardiovascular Surgical Patients Postoperative Exam
arm group label: Cardiovascular Surgical Patients Preoperative Exam
other name: FEES
intervention type: Diagnostic Test
intervention name: Simultaneous FEES and Videofluoroscopy instrumental swallowing exam
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. The participant will be asked to perform some voicing tasks, once completed, a videofluoroscopic swallowing exam will occur at the same time. This is like moving x-ray of the participant swallowing foods and liquids (barium).
arm group label: Cardiovascular Surgical Patients Postoperative Exam
other name: Endofluoroscopy
intervention type: Other
intervention name: Voluntary Cough Peak Expiratory Flow (PEF) Testing
description: Cough PEF will be performed to index a participant's physiologic airway defense capacity and strength. Testing will occur with the participant seated upright at 90 degrees using an analog peak flow meter with a one-way expiratory valve that prevents a participant from breathing air in from the device to reduce contamination.
arm group label: Cardiovascular Surgical Patients Postoperative Exam
intervention type: Other
intervention name: Reflex Cough Screen
description: Participants will be seated upright and administered reflex cough testing via a disposable adult aerosol mask with an attached nebulizer that contains a solution to elicit a cough response.
arm group label: Cardiovascular Surgical Patients Postoperative Exam
intervention type: Other
intervention name: Lingual Pressure Testing
description: Lingual strength will be evaluated using the Iowa Oral Pressure Instrument (IOPI). Participants will be seated upright, and the SLP will place the IOPI air-filled sensing bulb in the midline anterior position on the participant's tongue, posterior to the alveolar ridge.
arm group label: Cardiovascular Surgical Patients Postoperative Exam
intervention type: Diagnostic Test
intervention name: Speech Testing
description: Speech assessment will occur with the participant comfortably seated headset microphone with a lapel windscreen connected to a TASCAM DR40 to allow for high-quality audio recordings. Individuals will be asked to perform two maximal performance speech tasks that include vowel prolongation of /a/, and a Diadochokinetic (DDK) rate task to examine SMR for production of the word "buttercup."
arm group label: Cardiovascular Surgical Patients Postoperative Exam
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
country: United States
responsible party type: Sponsor
mesh term: Deglutition Disorders
mesh term: Cardiovascular Diseases
sharing ipd: No