Swallowing Impairment After COVID-19 Infection

Covid19 Clinical Trial

Official title:

The Pathophysiology of Swallowing Impairment in People Recovering From COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04537650
• Other study ID #: CAPCR 20-5477
• Secondary ID: 3R01DC011020-08S
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: September 2021
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Diagnostic Test:
• Videofluoroscopic Swallowing Study (VFSS)
A standardized dynamic radiographic examination of oropharyngeal swallowing

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario
United States	University of Florida	Gainesville	Florida

Sponsors (4)

Lead Sponsor	Collaborator
University Health Network, Toronto	McMaster University, National Institute on Deafness and Other Communication Disorders (NIDCD), University of Florida

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (3)

Rosenbek JC, Robbins JA, Roecker EB, Coyle JL, Wood JL. A penetration-aspiration scale. Dysphagia. 1996 Spring;11(2):93-8. doi: 10.1007/BF00417897. — View Citation

Steele CM, Bayley MT, Bohn MK, Higgins V, Peladeau-Pigeon M, Kulasingam V. Reference Values for Videofluoroscopic Measures of Swallowing: An Update. J Speech Lang Hear Res. 2023 Oct 4;66(10):3804-3824. doi: 10.1044/2023_JSLHR-23-00246. Epub 2023 Sep 5. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Videofluoroscopy session (single timepoint only)
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)	Videofluoroscopy session (single timepoint only)
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)	Videofluoroscopy session (single timepoint only)
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)	Videofluoroscopy session (single timepoint only)
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)	Videofluoroscopy session (single timepoint only)
Secondary	Number of Participants With Impaired LVC Integrity	Number of participants displaying incomplete laryngeal vestibule closure on thin liquids.	Videofluoroscopy (single timepoint only)