Swallowing Impairment After COVID-19 Infection

Completed

• Conditions: Covid19
• Interventions: Diagnostic Test: Videofluoroscopic Swallowing Study (VFSS)

• Registration Number: NCT04537650
• Lead Sponsor: University Health Network, Toronto

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.

Study Timeline

• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-01
• Study First Posted: 2020-09-03
• Study Start: 2021-01-01
• Status Verified: 2021-09
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Results First Submitted: 2023-11-08
• Results First Submitted QC: 2023-12-05
• Last Update Submitted: 2023-12-05
• Results First Posted: 2023-12-06
• Last Update Posted: 2023-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

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Exclusion Criteria

• Age under 18 years old
• Current pregnancy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19 Ventilated	Videofluoroscopic Swallowing Study (VFSS)	Participants who were diagnosed with COVID-19 prior to October, 2021 who required hospitalization in an ICU with mechanical ventilation during their illness.
COVID-19 Non-Ventilated	Videofluoroscopic Swallowing Study (VFSS)	Participants who were diagnosed with COVID-19 prior to October, 2021 who did not require mechanical ventilation during their illness.

Primary Outcome Measures

Name	Time	Method
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)
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.

Secondary Outcome Measures

Name	Time	Method
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 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 Impaired LVC Integrity	Videofluoroscopy (single timepoint only)	Number of participants displaying incomplete laryngeal vestibule closure on thin liquids.

Trial Locations

Locations (2)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada

University of Florida; 🇺🇸 Gainesville, Florida, United States