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临床试验/NCT06135207
NCT06135207已完成不适用

The Correlation Between COVID-19 and Dysphagia in Adults With Swallowing Disorders

Bezmialem Vakif University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2022年6月27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
75
试验地点
1
主要终点
Flexible Endoscopic Evaluation of Swallowing (FEES)

研究概览

简要总结

This study aims to investigate the correlation between COVID-19 and dysphagia in adults. The population of the study consisted of those who applied to Bezmialem University, Department of Otorhinolaryngology, Dysphagia Outpatient Clinic with the complaint of dysphagia. Patients older than 18 years of age, suffering from dysphagia and not having mental retardation were included in the study. Patients who did not have swallowing difficulties and refused to participate in the study were excluded.

详细描述

Coronavirus Disease 2019 (COVID-19) is characterized by involvement in multiple tissues and organs throughout the body. Conditions related to COVID-19 itself or its treatment are known to be associated with swallowing function. Our study aimed to investigate the correlation between COVID-19 and dysphagia in adults who applied to our dysphagia outpatient clinic. Patients over the age of 18, who applied to the dysphagia outpatient clinic were included in our study. Patients' demographic and COVID-19 information were recorded. Swallowing impairment of the patients was evaluated with the fiberoptic endoscopic swallowing study (FEES). FEES was scored with the Penetration-Aspiration Scale (PAS). Eating Assessment Tool-10 (EAT-10) questionnaire was used to examine how the quality of life of the patients was affected by swallowing difficulties. Oral motor dysfunction (OMD) evaluation was performed by the clinician.

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

  • Older than 18 years of age
  • Suffering from dysphagia
  • Not having mental retardation

排除标准

  • Patients who did not have swallowing difficulties
  • Refused to participate in the study

结局指标

主要结局

Flexible Endoscopic Evaluation of Swallowing (FEES)

时间窗: Three Months

Swallowing disorders of the patients were evaluated with fiberoptic endoscopic swallowing study (FEES).

Oral Motor Dysfunction (OMD)

时间窗: Three Months

Oral motor dysfunction (OMD) assessment of the patients was performed by physical examination of the oropharyngeal mechanism. Lips, tongue, palate, cheeks, teeth, jaw, larynx, and oral reflexes were evaluated with 26 items in terms of lifting, pressing, extending, retraction, approximation, rolling, lateralization, movement, coordination, speed, tone, and strength. A scale of 1-4 was used for scoring (1=within functional limits, 2=mild impairment, 3=moderate impairment, 4=severe impairment). The total score ranged from 26 to 104, with higher scores indicating greater degree of impairment. Only a score of 26 was considered normal within functional limits.

The Penetration - Aspiration Scale

时间窗: Three Months

The results of FEES was scored by the Penetration-Aspiration Scale. The Penetration - Aspiration Scale is an 8-point scale during instrumental swallowing assessments such as the fiberoptic endoscopic swallow study, both indicating the localization of the airway leak and demonstrating the response to the assessment.

Cranial Nerve Examination

时间窗: Three Months

Nervus trigeminus (V. cranial nerve), Nervus facialis (VII. cranial nerve), Nervus glossopharyngeus (IX. cranial nerve), Nervus vagus (X. cranial nerve) and Nervus hypoglossus (XII. cranial nerve) which are five cranial nerves involved in swallowing function were evaluated by the clinician.

Eating Assessment Tool-10 (EAT-10)

时间窗: Three Months

The Eating Assessment Tool-10 (EAT-10) was used to examine how the quality of life of the patients was affected because of their difficulty in swallowing.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gökhan Can TÖRPÜ

Principal Investigator

Bezmialem Vakif University

研究点 (1)

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