Dysphagia and VFMI in Cardiac Patients

Cardiac Disease Clinical Trial

Official title:

Dysphagia and Vocal Fold Mobility Impairment in Cardiac Surgical Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03768739
• Other study ID #: IRB201802740
• Status: Completed
• Start date: February 3, 2019
• Est. completion date: September 2, 2020

Study information

• Verified date: November 2020
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: September 2, 2020
• Est. primary completion date: September 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Disease
• Deglutition Disorders
• Heart Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Cardiovascular Clinic at UF Health UF	Gainesville	Florida
United States	Thoracic and Cardiovasscular Surgery at UF Health	Gainesville	Florida
United States	UF Health at the University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Vocal Fold Mobility Impairment	Index of left and right vocal fold movement	Baseline