Dysphagia and VFMI in Cardiac 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.

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Key information

Conditions

Cardiac Disease Cardiovascular Diseases Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Heart Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiovascular Clinic at UF Health UF, Gainesville, Florida, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fiberoptic Endoscopic Evaluation of Swallowing

Procedure

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

Primary outcomes

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.
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)
Vocal Fold Mobility Impairment

Time frame: Baseline

Index of left and right vocal fold movement

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Dysphagia and Vocal Fold Mobility Impairment in Cardiac Surgical Patients

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Dec 7, 2018
Registry last updated: Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed