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

NCT06770413 | Completed

• 1 other identifier: 4-2019-0111
• Study Type: observational
• Target: 328
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Pneumonia; Aspiration; Deglutition Disorders

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Pneumonia group

stroke patients who were diagnosed with pnuemonia within 4 week follow up period

non-Pneumonia group

stroke patients who were not diagnosed with pnuemonia within 4 week follow up period

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Stroke; Pneumonia; Deglutition Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 13, 2025
• Study Start: May 7, 2019
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: January 13, 2025

Record last verified: 2025-01

Locations

KR (1)