Dysphagia in Cardiac Surgical Patients

Study Overview
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Brief Summary
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Although dysphagia is a known complication of cardiac surgery, risk factors and sensitive bedside clinical markers of dysphagia have not yet been identified. This longitudinal study will enroll 380 cardiac surgical patients and identify contributing risk factors of incident cases of dysphagia and identify sensitive bedside markers of dysphagia. Statistical modeling will produce two pragmatic clinical tools - a risk prediction model and a beside screening tool to improve care models.

Detailed Description
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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. The study will identify risk factors for postoperative dysphagia and VFMI in cardiovascular patients to build a practical electronic risk-stratification tool. The study will also aim to identify sensitive bedside clinical markers of dysphagia in postoperative cardiovascular patients to develop a bedside screening tool. All participants with planned surgeries 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. For those without planned surgeries, the same course of tests with the exception of the preoperative research visit will be completed. Finally, health-related outcomes will be indexed in enrolled participants to determine the impact of dysphagia.

Official Title
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Mechanisms, Predictors & Clinical Markers of Dysphagia in Cardiac Surgical Patients_R01

Conditions
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Cardiovascular Diseases, Dysphagia

Intervention / Treatment
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* Diagnostic Test: Fiberoptic Endoscopic Evaluation of Swallowing
* Diagnostic Test: Simultaneous FEES and Videofluoroscopy instrumental swallowing exam
* Diagnostic Test: Videofluoroscopy instrumental swallowing exam (VFSS)
* Other: Voluntary Cough Peak Expiratory Flow (PEF) Testing
* Other: Reflex Cough Screen
* Other: Lingual Pressure Testing
* Diagnostic Test: Speech Testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals 18-90 years of age Undergoing planned or emergent cardiothoracic surgery via sternotomy and/or extended thoracotomy at the University of Florida Heart and Vascular Hospital Not pregnant Willing to participate in research exams. Exclusion Criteria: Pregnant women Those unwilling to participate in research exams.

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 |
| --- | --- |
| Cardiovascular Surgical Patients Preoperative Exam<br>All enrolled participants will undergo a baseline Fiberoptic Endoscopic Evaluation of Swallowing (FEES) or a Simultaneous FEES and Videofluoroscopy instrumental swallowing exam 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. | Diagnostic Test: Fiberoptic Endoscopic Evaluation of Swallowing<br>* 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.<br>* Other names: FEES;Diagnostic Test: Simultaneous FEES and Videofluoroscopy instrumental swallowing exam<br>* 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 a moving x-ray of the participant swallowing foods and liquids (barium).<br>* Other names: Endofluoroscopy;Diagnostic Test: Videofluoroscopy instrumental swallowing exam (VFSS)<br>* This is like a moving x-ray of the participant swallowing foods and liquids (barium).<br>* Other names: Modified barium swallow study;|
| Cardiovascular Surgical Patients Postoperative Exam<br>Participants without preoperative dysphagia will be seen for a postop exam within 72 hours of extubation. Simultaneous imaging using FEES and videofluoroscopy (or a FEES or VFSS exam in isolation) 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. | Diagnostic Test: Fiberoptic Endoscopic Evaluation of Swallowing<br>* 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.<br>* Other names: FEES;Diagnostic Test: Simultaneous FEES and Videofluoroscopy instrumental swallowing exam<br>* 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 a moving x-ray of the participant swallowing foods and liquids (barium).<br>* Other names: Endofluoroscopy;Diagnostic Test: Videofluoroscopy instrumental swallowing exam (VFSS)<br>* This is like a moving x-ray of the participant swallowing foods and liquids (barium).<br>* Other names: Modified barium swallow study;Other: Voluntary Cough Peak Expiratory Flow (PEF) Testing<br>* 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.<br>Other: Reflex Cough Screen<br>* 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.<br>Other: Lingual Pressure Testing<br>* 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.<br>Diagnostic Test: Speech Testing<br>* 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.<br>|

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. (Simultaneous or FEES exam) | Baseline (Prior to surgery) | 

Secondary 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. (Used in Simultaneous, FEES, or VFSS) | Follow-up - Within 72 hours following extubation from surgery and onward | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac surgery, Dysphagia, Extubation, Vocal Fold Mobility Impairment, Peak Cough Flow (PCF)