StrokeNCT06770413
Diagnostic Value of Modified Cough Reflex Test With Staged Water Swallow Test in Post-Stroke Patients Showing Dysphagia
An observational study of Stroke and Pneumonia, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Stroke, Pneumonia, Aspiration
- How many people
- 328 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 May 2019to 28 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- either ischemic or hemorrhagic stroke confirmed by a computed topography or magnetic resonance imaging
- aged 20 years or older
- signs or symptoms of dysphagia.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Stroke, Pneumonia, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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))
Measured: within 4 weeks after initial evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start7 May 2019
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770413
- Sponsor's protocol ID
- 4-2019-0111
- Status last verified
- Jan 2025
- First submitted
- 7 Jan 2025
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant date that uderlie the results reported in this article, after deidentification. Study protocol, statistical analysis plan will also be available. Data will be available to researchers who provide a methodologically sound proposal. Proposals should be directed to kimdy@yuhs.ac
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Modified Cough Reflex Test With Staged Water Swallow Test in Post-Stroke Patients Showing Dysphagia
- ClinicalTrials.gov ID
- NCT06770413
- Acronym / sponsor ID
- 4-2019-0111
- Conditions
- Stroke, Pneumonia, Aspiration, Deglutition Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 7 May 2019 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- either ischemic or hemorrhagic stroke confirmed by a computed topography or magnetic resonance imaging
- aged 20 years or older
- signs or symptoms of dysphagia.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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))
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Individual participant dataSharing planned: Undecided. Individual participant date that uderlie the results reported in this article, after deidentification. Study protocol, statistical analysis plan will also be available. Data will be available to researchers who provide a methodologically sound proposal. Proposals should be directed to kimdy@yuhs.ac
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Pneumonia, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of pnuemonia (time frame: within 4 weeks after initial evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.