Swallowing Impairment After COVID-19 Infection

University Health Network, Toronto

Status: Completed

Conditions: Covid19

Treatments: Diagnostic Test: Videofluoroscopic Swallowing Study (VFSS)

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04537650

3R01DC011020-08S1 (U.S. NIH Grant/Contract)

CAPCR 20-5477

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

44 participants in 2 patient groups

COVID-19 Ventilated

Description:

Participants who were diagnosed with COVID-19 prior to October, 2021 who required hospitalization in an ICU with mechanical ventilation during their illness.

Treatment:

Diagnostic Test: Videofluoroscopic Swallowing Study (VFSS)

COVID-19 Non-Ventilated

Description:

Participants who were diagnosed with COVID-19 prior to October, 2021 who did not require mechanical ventilation during their illness.

Treatment:

Diagnostic Test: Videofluoroscopic Swallowing Study (VFSS)