Dysphagia and VFMI in Cardiac Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Dysphagia and Vocal Fold Mobility Impairment in Cardiac Surgical Patients

Conditions
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Cardiac Disease

Intervention / Treatment
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* Procedure: Fiberoptic Endoscopic Evaluation of Swallowing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CICU extubated patients<br>Participants will undergo a Fiberoptic Endoscopic Evaluation of Swallowing (FEES) | Procedure: Fiberoptic Endoscopic Evaluation of Swallowing<br>* 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.<br>* Other names: FEES;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Penetration Aspiration Scale | 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. | Baseline | 
| Yale Residue Severity Rating Scale | 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) | Baseline; Day 30 | 
| Vocal Fold Mobility Impairment | Index of left and right vocal fold movement | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dysphagia, Extubation, Cardiac Intensive Care Unit (CICU), Forced Expiratory Volume in One second (FEV1), Peak Expiratory Flow (PEF)