Dysphagia and VFMI in Cardiac Patients

Dysphagia and Vocal Fold Mobility Impairment in Cardiac Surgical Patients

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Disease
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 207

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • UF Health at the University of Florida
    • Gainesville, Florida, United States, 32610
      • Cardiovascular Clinic at UF Health UF
    • Gainesville, Florida, United States, 32611
      • Thoracic and Cardiovasscular Surgery at UF Health

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

230 individuals undergoing cardiothoracic surgery will be enrolled in this study.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: FEES

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.	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2019
• Primary Completion (Actual): September 2, 2020
• Study Completion (Actual): September 2, 2020

Study Registration Dates

• First Submitted: December 5, 2018
• First Submitted That Met QC Criteria: December 5, 2018
• First Posted (Actual): December 7, 2018

Study Record Updates

• Last Update Posted (Actual): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Dysphagia; Extubation; Cardiac Intensive Care Unit (CICU); Forced Expiratory Volume in One second (FEV1); Peak Expiratory Flow (PEF)
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Heart Diseases; Deglutition Disorders
• Other Study ID Numbers: IRB201802740

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
• product manufactured in and exported from the U.S.: No