Dysphagia in Thoracic Surgical Patients

Thoracic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04487028
• Other study ID #: IRB202000724-A
• Status: Completed
• Start date: August 25, 2020
• Est. completion date: November 22, 2021

Study information

• Verified date: November 2021
• 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 throacic 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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: November 22, 2021
• Est. primary completion date: August 13, 2021
• 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 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.

Related Conditions & MeSH terms

• Deglutition Disorders
• Thoracic Diseases

Intervention

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.

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
Other	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
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
Secondary	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