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临床试验/NCT06770413
NCT06770413已完成不适用

Diagnostic Value of Modified Cough Reflex Test With Staged Water Swallow Test in Post-Stroke Patients Showing Dysphagia

Yonsei University1 个研究点 分布在 1 个国家目标入组 328 人开始时间: 2019年5月7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
328
试验地点
1
主要终点
Incidence of pnuemonia

研究概览

简要总结

The investigators conducted staged water swallow test (sWST) and modified cough reflex test (mCRT) on stroke patients referred for videofluoroscopic swallowing studies (VFSS) due to dysphagia. The patients were followed for up to four weeks to examine the incidence and timing of aspiration pneumonia, the relationship between these tests and VFSS results, and the diagnostic value of these tests as screening tools. Descriptive statistics will be presented for the incidence and timing of pneumonia, as well as the results of the SWST and MCRT. Regression analysis will be conducted to determine the explanatory power of each aspiration indicator (sWST and mCRT) in predicting aspiration or aspiration pneumonia. Additionally, using the VFSS results and the diagnosis of aspiration pneumonia as gold standards, the validity, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), odds ratio (OR), and relative risk (RR) for sWST, mCRT, and their combination will be calculated to evaluate their diagnostic value.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
20 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • either ischemic or hemorrhagic stroke confirmed by a computed topography or magnetic resonance imaging
  • aged 20 years or older
  • signs or symptoms of dysphagia.

排除标准

  • inability to maintain sitting posture with support
  • dyspnea requiring oxygen supplementation
  • diagnosed with aspiration pneumonia at enrollment
  • diagnosed with co-existing major neuromuscular disorders affecting swallowing
  • diagnosed with infectious diseases requiring isolation
  • refusal to participate

结局指标

主要结局

Incidence of pnuemonia

时间窗: within 4 weeks after initial evaluation

Pneumonia was diagnosed using the Mann criteria (when three or more of the following criteria were met: fever (\>38°C), productive cough with purulent sputum, abnormal respiratory examination (tachypnea \>22/min, tachycardia, inspiratory crackle, bronchial breathing), abnormal chest radiographic findings, arterial hypoxemia (PO2 \<70mmHg or SpO2 \<94%), and isolation of a relevant pathogen (positive gram stain or culture))

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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