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Dysphagia and VFMI in Cardiac Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03768739
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief Summary:
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.

Condition or disease Intervention/treatment
Cardiac Disease Procedure: Fiberoptic Endoscopic Evaluation of Swallowing

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 230 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dysphagia and Vocal Fold Mobility Impairment in Cardiac Surgical Patients
Actual Study Start Date : February 3, 2019
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
CICU extubated patients
Participants will undergo a Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
Procedure: Fiberoptic Endoscopic Evaluation of Swallowing
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.
Other Name: FEES




Primary Outcome Measures :
  1. Penetration Aspiration Scale [ Time Frame: Baseline ]
    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.

  2. Yale Residue Severity Rating Scale [ Time Frame: Baseline; Day 30 ]
    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)

  3. Vocal Fold Mobility Impairment [ Time Frame: Baseline ]
    Index of left and right vocal fold movement



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
230 individuals undergoing cardiothoracic surgery will be enrolled in this study.
Criteria

Inclusion Criteria:

  • adults aged 18 - 90 years old
  • undergoing planned or emergent cardiothoracic surgery via sternotomy and/or extended thoracotomy requiring cardiopulmonary bypass
  • willing to participate in post-operative swallowing evaluation testing

Exclusion Criteria:

  • Patients undergoing exclusively transcatheter valves
  • Patients undergoing exclusively thoracic endovascular aortic repair procedures
  • The inability to achieve appropriate alertness and cognitive status following procedure will exclude one from completing the study.
  • Participants must pass cognition, respiratory and physical abilities screening to ensure testing safety.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768739


Contacts
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Contact: Amber Anderson, MS 352-237-8632 amber.anderson@phhp.ufl.edu
Contact: Justine Allen, MS 352-273-8632 j.allen@ufl.edu

Locations
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United States, Florida
Cardiovascular Clinic at UF Health UF Recruiting
Gainesville, Florida, United States, 32610
UF Health at the University of Florida Recruiting
Gainesville, Florida, United States, 32610
Thoracic and Cardiovasscular Surgery at UF Health Recruiting
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Emily Plowman, PhD University of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03768739    
Other Study ID Numbers: IRB201802740
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
Dysphagia
Extubation
Cardiac Intensive Care Unit (CICU)
Forced Expiratory Volume in One second (FEV1)
Peak Expiratory Flow (PEF)
Additional relevant MeSH terms:
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Deglutition Disorders
Heart Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Cardiovascular Diseases