An observational study in Covid19, sponsored by University Health Network, Toronto. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-06.
Sponsored by University Health Network, Toronto · Observational
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.
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.
7,638 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 44 is below the median of 260 across 3,135 observational studies indexed under COVID-19.
Browse COVID-19 studies →University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Individuals recovering from COVID-19 infection
Exclusion Criteria:
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)
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)
A standardized dynamic radiographic examination of oropharyngeal swallowing
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.
Time frame: 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)
Time frame: Videofluoroscopy session (single timepoint only)
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)
Time frame: 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)
Time frame: 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)
Time frame: Videofluoroscopy session (single timepoint only)
Number of Participants With Impaired LVC Integrity
Number of participants displaying incomplete laryngeal vestibule closure on thin liquids.
Time frame: Videofluoroscopy (single timepoint only)
| Milestone | COVID-19 Ventilated | COVID-19 Non-ventilated |
|---|---|---|
| Started | 8 | 36 |
| Completed | 8 | 36 |
| Not completed | 0 | 0 |
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.
| Participants | COVID-19 Ventilated | COVID-19 Non-ventilated |
|---|---|---|
| Number of Participants With Impaired Swallowing Safety | 3 | 1 |
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)
| Participants | COVID-19 Ventilated | COVID-19 Non-ventilated |
|---|---|---|
| Number of Participants With Impaired Swallowing Efficiency | 4 | 0 |
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)
| Participants | COVID-19 Ventilated | COVID-19 Non-ventilated |
|---|---|---|
| Number of Participants With Prolonged Time-to-Laryngeal-Vestibule-Closure | 6 | 14 |
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)
| Participants | COVID-19 Ventilated | COVID-19 Non-ventilated |
|---|---|---|
| Number of Participants With Short Laryngeal Vestibule Closure Duration | 3 | 4 |
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)
| Participants | COVID-19 Ventilated | COVID-19 Non-ventilated |
|---|---|---|
| Number of Participants With Poor Pharyngeal Constriction | 6 | 6 |
Number of participants displaying incomplete laryngeal vestibule closure on thin liquids.
| Participants | COVID-19 Ventilated | COVID-19 Non-ventilated |
|---|---|---|
| Number of Participants With Impaired LVC Integrity | 1 | 0 |
Collected over Within 1 week of data collection. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| COVID-19 Ventilated | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| COVID-19 Non-ventilated | 0/36 (0%) | 0/36 (0%) | 0/36 (0%) |
| Age, Continuous(years) | COVID-19 Ventilated | COVID-19 Non-ventilated | Total |
|---|---|---|---|
| Mean | 62 (37 to 79) | 44 (21 to 78) | 48 (21 to 79) |
| Sex: Female, Male(Participants) | COVID-19 Ventilated | COVID-19 Non-ventilated | Total |
|---|---|---|---|
| Female | 1 | 30 | 31 |
| Male | 7 | 6 | 13 |
| Ethnicity (NIH/OMB)(Participants) | COVID-19 Ventilated | COVID-19 Non-ventilated | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 2 | 3 |
| Not Hispanic or Latino | 7 | 34 | 41 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | COVID-19 Ventilated | COVID-19 Non-ventilated | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 5 | 33 | 38 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Taste or Smell Impairment(Participants) | COVID-19 Ventilated | COVID-19 Non-ventilated | Total |
|---|---|---|---|
| YES (Taste/Smell impairment) | 7 | 13 | 20 |
| NO (No Taste/Smell impairment) | 1 | 23 | 24 |
| SSQ(units on a scale) | COVID-19 Ventilated | COVID-19 Non-ventilated | Total |
|---|---|---|---|
| Median | 98 (52 to 303) | 232 (55 to 422) | 158 (56 to 396) |
| Time since diagnosis(Months) | COVID-19 Ventilated | COVID-19 Non-ventilated | Total |
|---|---|---|---|
| Mean | 6 (2 to 14) | 7 (1 to 17) | 7 (1 to 17) |
| Tongue Weakness(Participants) | COVID-19 Ventilated | COVID-19 Non-ventilated | Total |
|---|---|---|---|
| Count of participants | 3 | 8 | 11 |
4 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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University Health Network, Toronto