Dysphagia Risk Stratification Tool and Clinical Bedside Screening Tool in the CICU.

• ClinicalTrials.gov Identifier: NCT04496986
• Recruitment Status: Not yet recruiting
• First Posted: August 4, 2020
• Last Update Posted: December 3, 2020
• Sponsor: University of Florida
• Information provided by (Responsible Party): University of Florida

Tracking Information

• First Submitted Date: July 29, 2020
• First Posted Date: August 4, 2020
• Last Update Posted Date: December 3, 2020
• Estimated Study Start Date: January 2021
• Estimated Primary Completion Date: September 1, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 29, 2020)

• Penetration Aspiration Scale [ Time Frame: Baseline (Prior to surgery) ]
  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.
• Penetration Aspiration Scale [ Time Frame: Follow-up - Within 72 hours following extubation from surgery ]
  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 29, 2020)

• Yale Residue Severity Rating Scale [ Time Frame: Baseline (Prior to surgery) ]
  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).
• Yale Residue Severity Rating Scale [ Time Frame: Follow-up - Within 72 hours following extubation from surgery ]
  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 29, 2020)

• Vocal Fold Mobility Impairment [ Time Frame: Baseline (Prior to surgery) ]
  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.
• Vocal Fold Mobility Impairment [ Time Frame: Follow-up - Within 72 hours following extubation from surgery ]
  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: Same as current

Descriptive Information

• Brief Title: Dysphagia Risk Stratification Tool and Clinical Bedside Screening Tool in the CICU.
• Official Title: Development of a Dysphagia Risk Stratification Tool and Clinical Bedside Screening Tool in Cardiovascular Surgical Patients
• Brief Summary: The proposed study seeks to determine the incidence of dysphagia and vocal fold mobility impairment (VFMI) in individuals undergoing cardiovascular 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 cardiovascular 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 patients undergoing cardiovascular 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. Participants will undergo two research visits (one pre and one postoperative) where they will undergo an instrumental swallowing test and complete several patient report outcomes and quick clinical tests. Finally, health-related outcomes will be indexed in enrolled participants to determine the impact of dysphagia.
• 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: 360 individuals undergoing cardiovascular surgery will be enrolled in this study.
• Condition: Cardiovascular 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

Cardiovascular 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: Not yet recruiting
• Estimated Enrollment (submitted: July 29, 2020): 360
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2022
• Estimated Primary Completion Date: September 1, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. adults aged 18 - 90 years old
2. undergoing planned or emergent cardiovascular surgery via sternotomy and/or extended thoracotomy
3. confirmed COVID-19 negative test (completed in all patients as standard of care)
4. willing to participate in two research testing sessions

Exclusion Criteria:

1. individuals under the age of 18
2. pregnant women
3. those testing positive for COVID-19

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; 352-427-6579; amber.anderson@phhp.ufl.edu

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT04496986
• Other Study ID Numbers: IRB202001367; OCR39324 ( Other Identifier: OCR OnCore )
• 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: December 2020