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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06770413

Enrollment

328

Registered

2025-01-13

Start date

2019-05-07

Completion date

2024-02-28

Last updated

2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aspiration, Deglutition Disorders, Pneumonia, Stroke

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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))

Countries

South Korea

Outcome results