Dysphagia in Thoracic Surgical Patients

NCT04487028 | Completed

• 1 other identifier: IRB202000724-A
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 3

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.

Conditions

Thoracic Diseases

Keywords

Dysphagia; Extubation; Vocal Fold Mobility Impairment; Peak Cough Flow (PCF)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Yale Residue Severity Rating Scale

  Baseline

Other Outcomes (1)

• Vocal Fold Mobility Impairment

  Baseline

Study Arms (1)

Thoracic Surgical Patients

Participants will undergo a Fiberoptic Endoscopic Evaluation of Swallowing (FEES)

Procedure: Fiberoptic Endoscopic Evaluation of Swallowing

Interventions

Fiberoptic Endoscopic Evaluation of Swallowing PROCEDURE

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.

Also known as: FEES

Thoracic Surgical Patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (3)

Cardiovascular Clinic at UF Health UF

Gainesville, Florida, 32610, United States

Location

Thoracic and Cardiovasscular Surgery at UF Health

Gainesville, Florida, 32610, United States

Location

UF Health at the University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Thoracic Diseases; Deglutition Disorders

Interventions

Fees and Charges

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations

Study Officials

• Emily K Plowman, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 27, 2020
• Study Start: August 25, 2020
• Primary Completion: August 13, 2021
• Study Completion: November 22, 2021
• Last Updated: November 24, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)