Dysphagia in Thoracic Surgical Patients

Completed

• Conditions: Thoracic Diseases
• Interventions: Procedure: Fiberoptic Endoscopic Evaluation of Swallowing

• Registration Number: NCT04487028
• 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 throacic 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 thoracic 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 thoracic 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

Study Timeline

• Study First Submitted: 2020-07-22
• Study First Submitted QC: 2020-07-22
• Study First Posted: 2020-07-27
• Study Start: 2020-08-25
• Primary Completion: 2021-08-13
• Status Verified: 2021-11
• Study Completion: 2021-11-22
• Last Update Submitted: 2021-11-23
• Last Update Posted: 2021-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• adults aged 18 - 90 years old
• undergoing planned or emergent thoracic surgery via clamshell and/or extended thoracotomy
• confirmed negative COVID-19 test
• willing to participate in postoperative swallowing evaluation testing.

Exclusion Criteria

• individuals under the age of 18.
• pregnant
• or those testing positive for COVID-19
• Additionally, the inability to demonstrate appropriate alertness and cognitive status following the procedure will exclude a participant from participating in this study to ensure protection of vulnerable individuals.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Thoracic Surgical 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.

Secondary Outcome Measures

Name	Time	Method
Yale Residue Severity Rating Scale	Baseline	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)

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

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

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