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

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.

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Key information

Conditions

Stroke Aspiration Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Infections Lung Diseases Nervous System Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Pneumonia Respiratory Tract Diseases Respiratory Tract Infections Vascular Diseases

Age range

20 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Severance hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Incidence of pnuemonia

Time frame: 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))

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2019
Primary completion: 2024
Study completion: 2024
First posted: Jan 13, 2025
Registry last updated: Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed