NCT04537650|CompletedResults
Swallowing Impairment After COVID-19 Infection
The Pathophysiology of Swallowing Impairment in People Recovering From COVID-19
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The Pathophysiology of Swallowing Impairment in People Recovering From COVID-19
Sponsor study identifier
Secondary identifiers
observational
44
2 countries
2
Study Start
January 1, 2021
Actual (reported)Primary Completion
March 31, 2022
Actual (reported)Study Completion
March 31, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1, 2020
Actual (reported)September 3, 2020
Actual (reported)January 1, 2021
Actual (reported)March 31, 2022
Actual (reported)March 31, 2022
Actual (reported)December 6, 2023
Actual (reported)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)
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)
Number of Participants With Prolonged Time-to-Laryngeal-Vestibule-Closure
Videofluoroscopy session (single timepoint only)
Number of Participants With Short Laryngeal Vestibule Closure Duration
Videofluoroscopy session (single timepoint only)
Number of Participants With Poor Pharyngeal Constriction
Videofluoroscopy session (single timepoint only)
Number of Participants With Impaired LVC Integrity
Videofluoroscopy (single timepoint only)
Participants who were diagnosed with COVID-19 prior to October, 2021 who required hospitalization in an ICU with mechanical ventilation during their illness.
Participants who were diagnosed with COVID-19 prior to October, 2021 who did not require mechanical ventilation during their illness.
A standardized dynamic radiographic examination of oropharyngeal swallowing
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Individuals recovering from COVID-19 infection
University of Florida
Gainesville, Florida, 32610-3006, United States
McMaster University
Hamilton, Ontario, Canada
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.
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.
Catriona M Steele, PhD
University Health Network, Toronto
44 participants (actual enrollment reported by the registry).
First Submitted
September 1, 2020
First Posted
September 3, 2020
Study Start
January 1, 2021
Actual (reported)Virtual Assistant for COVID-19 PPE
Contact the study team to confirm eligibility.
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.
Primary Completion
March 31, 2022
Actual (reported)Study Completion
March 31, 2022
Actual (reported)Last Updated
December 6, 2023
Results First Posted
December 6, 2023
Record last verified: 2021-09
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Source: ClinicalTrials.gov.
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