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

Completed

• Conditions: Stroke; Pneumonia; Aspiration; Deglutition Disorders

• Registration Number: NCT06770413
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-07
• Primary Completion: 2024-02-28
• Study Completion: 2024-02-28
• Status Verified: 2025-01
• Study First Submitted: 2025-01-07
• Study First Submitted QC: 2025-01-07
• Last Update Submitted: 2025-01-07
• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 328

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of pnuemonia	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))

Trial Locations

Locations (1)

Severance hospital; 🇰🇷 Seoul, Korea, Republic of