Swallowing Impairment After COVID-19 Infection
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Swallowing safety [Videofluoroscopy session (single timepoint only)]
Frequency of boluses (per consistency) demonstrating airway invasion, defined as Penetration-Aspiration Scale score of 3 and higher (Rosenbek et al., 1996)
- Swallowing efficiency [Videofluoroscopy session (single timepoint only)]
Frequency of boluses (per consistency) demonstrating pharyngeal residue measured to fill more than 1% of an anatomical reference scalar [%(C2-4)squared] (Steele et al., 2019)
Secondary Outcome Measures
- Time-to-Laryngeal-Vestibule-Closure [Videofluoroscopy session (single timepoint only)]
Frequency of boluses (per consistency) on which the participant displays prolonged time to airway closure (i.e. Laryngeal Vestibule Closure), defined as values falling more than 1 standard deviation above the healthy reference mean (Steele et al., 2019)
- Laryngeal Vestibule Closure duration [Videofluoroscopy session (single timepoint only)]
Frequency of boluses (per consistency) on which the participant displays short airway closure (i.e. laryngeal vestibule closure), defined as a duration more than 1 standard deviation below the healthy reference mean (Steele et al., 2019)
- Pharyngeal Constriction [Videofluoroscopy session (single timepoint only)]
Frequency of boluses (per consistency) on which the participant displays pharyngeal area above the 75th percentile healthy reference value on the frame of maximum constriction (Steele et al., 2019)
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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Adequate comprehension of English to understand the consent form and follow study instructions
Exclusion Criteria:
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Age under 18 years old
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Current pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Florida | Gainesville | Florida | United States | 32610-3006 |
| 2 | McMaster University | Hamilton | Ontario | Canada |
Sponsors and Collaborators
- University Health Network, Toronto
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- McMaster University
- University of Florida
Investigators
- Principal Investigator: Catriona M Steele, PhD, University Health Network, Toronto
Study Documents (Full-Text)
None provided.More Information
Publications
- Rosenbek JC, Robbins JA, Roecker EB, Coyle JL, Wood JL. A penetration-aspiration scale. Dysphagia. 1996 Spring;11(2):93-8.
- Steele CM, Peladeau-Pigeon M, Barbon CAE, Guida BT, Namasivayam-MacDonald AM, Nascimento WV, Smaoui S, Tapson MS, Valenzano TJ, Waito AA, Wolkin TS. Reference Values for Healthy Swallowing Across the Range From Thin to Extremely Thick Liquids. J Speech Lang Hear Res. 2019 May 21;62(5):1338-1363. doi: 10.1044/2019_JSLHR-S-18-0448.
- CAPCR 20-5477
- 3R01DC011020-08S1