Dysphagia in Cardiac Surgical Patients_

Mechanisms, Predictors and Clinical Markers of Dysphagia in Cardiac Surgical Patients

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.

Study Overview

• Status: Withdrawn
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Diagnostic test: Fiberoptic Endoscopic Evaluation of Swallowing; Other: Voluntary Cough Peak Expiratory Flow (PEF) Testing; Other: Reflex Cough Screen; Other: Lingual Pressure Testing; Diagnostic test: Speech Testing; Diagnostic test: Simultaneous FEES and Videofluoroscopy instrumental swallowing exam

Detailed Description

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.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

360 individuals undergoing cardiac surgery will be enrolled in this study.

Description

Inclusion Criteria: 1) individuals over 18 years of age, 2) undergoing a cardiovascular procedure at the University of Florida Heart and Vascular Hospital, 3) confirmed negative COVID-19 test result, 4) no allergies to barium, 5) not pregnant (female participants), and 6) willing to participate in research exams.

Exclusion Criteria: 1) individuals under the age of 18, 2) patients with a confirmed positive COVID-19 test result, 3) participants with allergies to barium, 4) pregnant women, or 5) unwilling to participate in research exams.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cardiovascular Surgical Patients Preoperative Exam; 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.	Diagnostic test: Fiberoptic Endoscopic Evaluation of Swallowing; 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.; Other Names: FEES
Cardiovascular Surgical Patients Postoperative Exam; 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.	Diagnostic test: Fiberoptic Endoscopic Evaluation of Swallowing; 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.; Other Names: FEES; Other: Voluntary Cough Peak Expiratory Flow (PEF) Testing; 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.; Other: Reflex Cough Screen; 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.; Other: Lingual Pressure Testing; 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.; Diagnostic test: Speech Testing; 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."; Diagnostic test: Simultaneous FEES and Videofluoroscopy instrumental swallowing exam; 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).; Other Names: Endofluoroscopy

What is the study measuring?

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. (FEES)	Baseline (Prior to surgery)
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 both FEES and VFSS)	Follow-up - Within 72 hours following extubation from surgery and onward

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Emily K Plowman, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): September 1, 2025
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: July 29, 2020
• First Submitted That Met QC Criteria: July 29, 2020
• First Posted (Actual): August 4, 2020

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 19, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Dysphagia; Extubation; Peak Cough Flow (PCF); Vocal Fold Mobility Impairment
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Cardiovascular Diseases; Deglutition Disorders
• Other Study ID Numbers: IRB202001367; OCR39324 (Other Identifier: OCR OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No