Swallowing Impairment After COVID-19 Infection

Study Overview
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Brief Summary
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This is an observational study, in which people recovering from COVID-19 infection will attend an outpatient clinic for a comprehensive swallowing assessment. The assessment will include a videofluoroscopy, measurement of respiratory-swallow coordination using a digital stethoscope, measures of tongue and cough strength and patient reported measures that will help us to understand the presence and impact of swallowing impairment (dysphagia) in this population.

Detailed Description
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The recent spread of COVID-19 has led to an international pandemic, with >3 million confirmed cases to date worldwide, of which 1 million confirmed cases and >50,000 deaths have been reported in the USA. Infected individuals commonly experience severe respiratory difficulties and pneumonia, leading to hospital admission and the need for intensive care and mechanical ventilation. Emerging evidence suggests that impaired taste and smell may be early markers of the disease, and that in severe cases, there may be neurological damage in in the medulla, an important brainstem control site for both respiration and swallowing. Given the overlapping neuroanatomical regulation of breathing and swallowing, the investigators hypothesize that dysphagia (swallowing impairment) will be common in People recovering from COVID-19 (PrC-19) and associated with poorer outcomes. The investigators will offer comprehensive swallowing assessments to PrC-19 after initial recovery and a confirmed negative test for continuing COVID-19 infection. Study sites will be located in the Toronto area (PI Steele); the Hamilton-Niagara region to the west of Toronto (Co-I Namasivayam-MacDonald) and in Gainesville, Florida (Co-I Plowman). The assessments will include the collection of case history information, videofluoroscopy (i.e., a dynamic swallowing x-ray), use of a digital stethoscope to measure respiratory-swallow coordination, measures of other risk factors for dysphagia (e.g. bulbar muscle strength) and patient-reported outcomes. Detailed analyses of the videofluoroscopy swallowing studies (i.e. dynamic x-rays) will identify specific measures of swallowing that fall outside the range of normal variation based on comparison to healthy reference values established through the PI's NIH-funded research program exploring swallowing physiology on liquids of different consistencies.

Official Title
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The Pathophysiology of Swallowing Impairment in People Recovering From COVID-19

Conditions
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Covid19

Intervention / Treatment
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* Diagnostic Test: Videofluoroscopic Swallowing Study (VFSS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: People who tested positive or received a presumed positive diagnosis of COVID-19 infection not earlier than March 1, 2020 and who are at least 2 weeks post positive diagnosis and the initiation of medical management of COVID-19 infection Adequate comprehension of English to understand the consent form and follow study instructions Exclusion Criteria: Age under 18 years old Current pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 Ventilated<br>Participants who were diagnosed with COVID-19 prior to October, 2021 who required hospitalization in an ICU with mechanical ventilation during their illness. | Diagnostic Test: Videofluoroscopic Swallowing Study (VFSS)<br>* A standardized dynamic radiographic examination of oropharyngeal swallowing<br>|
| COVID-19 Non-Ventilated<br>Participants who were diagnosed with COVID-19 prior to October, 2021 who did not require mechanical ventilation during their illness. | Diagnostic Test: Videofluoroscopic Swallowing Study (VFSS)<br>* A standardized dynamic radiographic examination of oropharyngeal swallowing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Impaired Swallowing Safety | Frequency of participants demonstrating airway invasion on thin liquids, defined as Penetration-Aspiration Scale score of 3 and higher (Rosenbek et al., 1996). Higher scores indicate worse function. | Videofluoroscopy session (single timepoint only) | 
| Number of Participants With Impaired Swallowing Efficiency | Frequency of participants demonstrating pharyngeal residue on extremely thick liquids measured to fill more than 1.5% of an anatomical reference scalar [%(C2-4)squared] (Steele et al., 2019) | Videofluoroscopy session (single timepoint only) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Prolonged Time-to-Laryngeal-Vestibule-Closure | Frequency of participants displaying prolonged time to airway closure (i.e. Laryngeal Vestibule Closure) on thin liquids, defined as values falling above the healthy reference 75th percentile (Steele et al., 2023) | Videofluoroscopy session (single timepoint only) | 
| Number of Participants With Short Laryngeal Vestibule Closure Duration | Frequency of participants displaying short airway closure (i.e. laryngeal vestibule closure) on thin liquids, defined as a duration below the healthy reference 25th percentile (Steele et al., 2023) | Videofluoroscopy session (single timepoint only) | 
| Number of Participants With Poor Pharyngeal Constriction | Frequency of participants displaying poor pharyngeal constriction on extremely thick liquids, defined as pharyngeal area above the 75th percentile healthy reference value on the frame of maximum constriction (Steele et al., 2023) | Videofluoroscopy session (single timepoint only) | 
| Number of Participants With Impaired LVC Integrity | Number of participants displaying incomplete laryngeal vestibule closure on thin liquids. | Videofluoroscopy (single timepoint only) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Swallowing