NCT06770413|Completed
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Sponsor study identifier
observational
328
1 country
1
Study Start
May 7, 2019
Actual (reported)Primary Completion
February 28, 2024
Actual (reported)Study Completion
February 28, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 28, 2024
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 7, 2019
Actual (reported)February 28, 2024
Actual (reported)February 28, 2024
Actual (reported)January 7, 2025
Actual (reported)January 13, 2025
Actual (reported)Incidence of pnuemonia
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))
within 4 weeks after initial evaluation
stroke patients who were diagnosed with pnuemonia within 4 week follow up period
stroke patients who were not diagnosed with pnuemonia within 4 week follow up period
Stroke patients who were admittied to a single tertiary hospital and demonstrating signs of dysphagia. Dysphagia was documented when any of the following criteria were met: impaired sensory or motor function of oral cavity structures (jaw, lip, tongue, palate, and cheeks), impaired cranial nerve functions (trigeminal, facial, glossopharyngeal, and hypoglossal nerves), voice change (wet or gurgly voice) after swallowing, drooling, or buccofacial apraxia.
Severance hospital
Seoul, 120-752, South Korea
328 participants (actual enrollment reported by the registry).
First Submitted
January 7, 2025
First Posted
January 13, 2025
Study Start
May 7, 2019
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
February 28, 2024
Actual (reported)Study Completion
February 28, 2024
Actual (reported)Last Updated
January 13, 2025
Record last verified: 2025-01
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