Dysphagia and VFMI in Cardiac Patients

Completed

• Conditions: Cardiac Disease
• Interventions: Procedure: Fiberoptic Endoscopic Evaluation of Swallowing

• Registration Number: NCT03768739
• Lead Sponsor: University of Florida

Brief 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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2018-12-05
• Study First Submitted QC: 2018-12-05
• Study First Posted: 2018-12-07
• Study Start: 2019-02-03
• Primary Completion: 2020-09-02
• Study Completion: 2020-09-02
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

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

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CICU extubated patients	Fiberoptic Endoscopic Evaluation of Swallowing	Participants will undergo a Fiberoptic Endoscopic Evaluation of Swallowing (FEES)

Primary Outcome Measures

Name	Time	Method
Penetration Aspiration Scale	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.
Vocal Fold Mobility Impairment	Baseline	Index of left and right vocal fold movement
Yale Residue Severity Rating Scale	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)

Trial Locations

Locations (3)

Cardiovascular Clinic at UF Health UF; 🇺🇸 Gainesville, Florida, United States

UF Health at the University of Florida; 🇺🇸 Gainesville, Florida, United States

Thoracic and Cardiovasscular Surgery at UF Health; 🇺🇸 Gainesville, Florida, United States