Covid19
Conditions
Keywords
Swallowing
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.
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.
Interventions
DIAGNOSTIC_TESTVideofluoroscopic Swallowing Study (VFSS)
A standardized dynamic radiographic examination of oropharyngeal swallowing
Sponsors
National Institute on Deafness and Other Communication Disorders (NIDCD)
McMaster University
University of Florida
University Health Network, Toronto
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Impaired Swallowing Safety | Videofluoroscopy session (single timepoint only) | 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. |
| Number of Participants With Impaired Swallowing Efficiency | Videofluoroscopy session (single timepoint only) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Prolonged Time-to-Laryngeal-Vestibule-Closure | Videofluoroscopy session (single timepoint only) | 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) |
| Number of Participants With Short Laryngeal Vestibule Closure Duration | Videofluoroscopy session (single timepoint only) | 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) |
| Number of Participants With Poor Pharyngeal Constriction | Videofluoroscopy session (single timepoint only) | 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) |
| Number of Participants With Impaired LVC Integrity | Videofluoroscopy (single timepoint only) | Number of participants displaying incomplete laryngeal vestibule closure on thin liquids. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| COVID-19 Ventilated This was a group of Community-Dwelling adults who had a history of COVID-19 infection prior to October, 2021 and who were hospitalized and required ICU care with mechanical ventilation during their COVID-19 infection | 8 |
| COVID-19 Non-ventilated This was a group of Community-Dwelling adults who had a history of COVID-19 infection prior to October, 2021 but who did not require mechanical ventilation during their COVID-19 infection. | 36 |
| Total | 44 |
Baseline characteristics
| Characteristic | Total | COVID-19 Ventilated | COVID-19 Non-ventilated |
|---|---|---|---|
| Age, Continuous | 48 years | 62 years | 44 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants | 7 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fail water swallow screen (3 sips) | 18 Participants | 4 Participants | 14 Participants |
| Fail water swallow screen (90cc) | 16 Participants | 3 Participants | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 38 Participants | 5 Participants | 33 Participants |
| Reduced peak cough flow | 7 Participants | 1 Participants | 6 Participants |
| Sex: Female, Male Female | 31 Participants | 1 Participants | 30 Participants |
| Sex: Female, Male Male | 13 Participants | 7 Participants | 6 Participants |
| SSQ | 158 units on a scale | 98 units on a scale | 232 units on a scale |
| SSQ Impaired | 13 Participants | 1 Participants | 12 Participants |
| Taste or Smell Impairment NO (No Taste/Smell impairment) | 24 Participants | 1 Participants | 23 Participants |
| Taste or Smell Impairment YES (Taste/Smell impairment) | 20 Participants | 7 Participants | 13 Participants |
| Time since diagnosis | 7 Months | 6 Months | 7 Months |
| Tongue Weakness | 11 Participants | 3 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 36 |
| other Total, other adverse events | 0 / 8 | 0 / 36 |
| serious Total, serious adverse events | 0 / 8 | 0 / 36 |
Outcome results
Primary
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COVID-19 Ventilated | Number of Participants With Impaired Swallowing Efficiency | 4 Participants |
| COVID-19 Non-ventilated | Number of Participants With Impaired Swallowing Efficiency | 0 Participants |
p-value: <0.00195% CI: [4.15, 487.5]Chi-squared
Primary
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COVID-19 Ventilated | Number of Participants With Impaired Swallowing Safety | 3 Participants |
| COVID-19 Non-ventilated | Number of Participants With Impaired Swallowing Safety | 1 Participants |
p-value: <0.00195% CI: [1.8, 243.24]Chi-squared
Secondary
Number of Participants With Impaired LVC Integrity
Number of participants displaying incomplete laryngeal vestibule closure on thin liquids.
Time frame: Videofluoroscopy (single timepoint only)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COVID-19 Ventilated | Number of Participants With Impaired LVC Integrity | 1 Participants |
| COVID-19 Non-ventilated | Number of Participants With Impaired LVC Integrity | 0 Participants |
Secondary
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COVID-19 Ventilated | Number of Participants With Poor Pharyngeal Constriction | 6 Participants |
| COVID-19 Non-ventilated | Number of Participants With Poor Pharyngeal Constriction | 6 Participants |
Secondary
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COVID-19 Ventilated | Number of Participants With Prolonged Time-to-Laryngeal-Vestibule-Closure | 6 Participants |
| COVID-19 Non-ventilated | Number of Participants With Prolonged Time-to-Laryngeal-Vestibule-Closure | 14 Participants |
Secondary
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COVID-19 Ventilated | Number of Participants With Short Laryngeal Vestibule Closure Duration | 3 Participants |
| COVID-19 Non-ventilated | Number of Participants With Short Laryngeal Vestibule Closure Duration | 4 Participants |