Swallowing Impairment After COVID-19 Infection

NCT04537650 | Completed Results

• 2 other identifiers: CAPCR 20-54773R01DC011020-08S1
• Study Type: observational
• Target: 44
• Locations: 2 countries
• Sites: 2

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.

Conditions

Covid19

Keywords

Swallowing

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (4)

• 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)

Study Arms (2)

COVID-19 Ventilated

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

Diagnostic Test: Videofluoroscopic Swallowing Study (VFSS)

COVID-19 Non-Ventilated

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

Diagnostic Test: Videofluoroscopic Swallowing Study (VFSS)

Interventions

Videofluoroscopic Swallowing Study (VFSS) DIAGNOSTIC_TEST

A standardized dynamic radiographic examination of oropharyngeal swallowing

COVID-19 Non-Ventilated; COVID-19 Ventilated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals recovering from COVID-19 infection

You may qualify if:

• 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

You may not qualify if:

• Age under 18 years old
• Current pregnancy

Sponsors & Collaborators

• University Health Network, Toronto: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator
• McMaster University: collaborator
• University of Florida: collaborator

Study Sites (2)

University of Florida

Gainesville, Florida, 32610-3006, United States

Location

McMaster University

Hamilton, Ontario, Canada

Location

Related Publications (3)

• 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.

  PMID: 31021676 BACKGROUND

• 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.

  PMID: 8721066 BACKGROUND

• 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.

  PMID: 37669617 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Catriona M. Steele, PhD
• Organization: KITE Research Institute - University Health Network

catriona.steele@uhn.ca

14165973422

Study Officials

• Catriona M Steele, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 3, 2020
• Study Start: January 1, 2021
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: December 6, 2023
• Results First Posted: December 6, 2023

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (1)