Dysphagia in Thoracic Surgical Patients

Dysphagia in Thoracic Surgical Patients: Incidence, Risk-factors, and Health Related Outcomes

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.

Study Overview

• Status: Completed
• Conditions: Thoracic Diseases
• Intervention / Treatment: Procedure: Fiberoptic Endoscopic Evaluation of Swallowing

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 Type: Observational
• Enrollment (Actual): 61

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, 32610
      • 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

240 individuals undergoing thoracic surgery will be enrolled in this study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Thoracic Surgical Patients; Participants will undergo a Fiberoptic Endoscopic Evaluation of Swallowing (FEES)	Procedure: Fiberoptic Endoscopic Evaluation of Swallowing; This procedure involves inserting a flexible laryngoscope that contains a light source and video camera on the end through the open passage of the nose towards 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vocal Fold Mobility Impairment	During a Fiberoptic Endoscopic Evaluation of Swallowing (FEES), the vocal folds will be visualized using a small camera passed through the open nasal passage. The patient will be asked to make a series of vocal tasks so that we can visualize their movement, any immobility will be notated.	Baseline

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2020
• Primary Completion (Actual): August 13, 2021
• Study Completion (Actual): November 22, 2021

Study Registration Dates

• First Submitted: July 22, 2020
• First Submitted That Met QC Criteria: July 22, 2020
• First Posted (Actual): July 27, 2020

Study Record Updates

• Last Update Posted (Actual): November 24, 2021
• Last Update Submitted That Met QC Criteria: November 23, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Dysphagia; Extubation; Peak Cough Flow (PCF); Vocal Fold Mobility Impairment
• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders; Thoracic Diseases
• Other Study ID Numbers: IRB202000724-A

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