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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

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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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