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临床试验/NCT04537650
NCT04537650已完成不适用

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

University Health Network, Toronto2 个研究点 分布在 2 个国家目标入组 44 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
2
主要终点
Number of Participants With Impaired Swallowing Efficiency

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Age under 18 years old
  • Current pregnancy

结局指标

主要结局

Number of Participants With Impaired Swallowing Efficiency

时间窗: 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

时间窗: 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.

次要结局

  • Number of Participants With Poor Pharyngeal Constriction(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 Impaired LVC Integrity(Videofluoroscopy (single timepoint only))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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