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

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

Study Description
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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.

Condition or disease Intervention/treatment
Cardiovascular Diseases Procedure: Fiberoptic Endoscopic Evaluation of Swallowing

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 Design
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Study Type : Observational
Estimated Enrollment : 360 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of a Dysphagia Risk Stratification Tool and Clinical Bedside Screening Tool in Cardiovascular Surgical Patients
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : December 31, 2022

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Cardiovascular 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 Name: FEES


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).


Other Outcome Measures:
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
360 individuals undergoing cardiovascular surgery will be enrolled in this study.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04496986


Contacts
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Contact: Amber R Anderson, MS 352-427-6579 amber.anderson@phhp.ufl.edu

Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Emily K Plowman, PhD University of Florida
More Information
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT04496986    
Other Study ID Numbers: IRB202001367
OCR39324 ( Other Identifier: OCR OnCore )
First Posted: August 4, 2020    Key Record Dates
Last Update Posted: December 3, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
Dysphagia
Extubation
Vocal Fold Mobility Impairment
Peak Cough Flow (PCF)
Additional relevant MeSH terms:
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Deglutition Disorders
Cardiovascular Diseases
Esophageal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases