Dysphagia in Thoracic Surgical Patients

• ClinicalTrials.gov Identifier: NCT04487028
• Recruitment Status: Recruiting
• First Posted: July 27, 2020
• Last Update Posted: November 19, 2020
• Sponsor: University of Florida
• Information provided by (Responsible Party): University of Florida

Tracking Information

• First Submitted Date: July 22, 2020
• First Posted Date: July 27, 2020
• Last Update Posted Date: November 19, 2020
• Actual Study Start Date: August 25, 2020
• Estimated Primary Completion Date: January 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 22, 2020)

Penetration Aspiration Scale [ Time Frame: 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 22, 2020)

Yale Residue Severity Rating Scale [ Time Frame: 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).

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: July 27, 2020)

Vocal Fold Mobility Impairment [ Time Frame: Baseline ]

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.

Original Other Pre-specified Outcome Measures (submitted: July 22, 2020)

Vocal Fold Mobility Impairment [ Time Frame: Baseline ]

Index of left and right vocal fold movement

Descriptive Information

• Brief Title: Dysphagia in Thoracic Surgical Patients
• Official Title: Dysphagia in Thoracic Surgical Patients: Incidence, Risk-factors, and Health Related Outcomes
• 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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: 240 individuals undergoing thoracic surgery will be enrolled in this study.
• Condition: 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.

Other Name: FEES

Study Groups/Cohorts

Thoracic Surgical Patients

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

Intervention: Procedure: Fiberoptic Endoscopic Evaluation of Swallowing

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 22, 2020): 240
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 2022
• Estimated Primary Completion Date: January 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Amber R Anderson, MS; 352-237-8632; amber.anderson@phhp.ufl.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04487028
• Other Study ID Numbers: IRB202000724-A
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: University of Florida
• Study Sponsor: University of Florida
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Florida
• Verification Date: November 2020