Acute StrokeNCT04874454
Evaluating Potential Risk of Choking by Laryngeal Ultrasound in Patients With Acute Stroke
A study testing ultrasound in people with Acute Stroke, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The investigators evaluate the vocal cord movement in patients with acute stroke by ultrasound. The occurrence of choking or aspiration pneumonia will be collected in one year after the index stroke. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Stroke
- What is being tested?
- ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Jul 2023to 31 Dec 2026
- Phase
- Interventional
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute stroke (in one month) patients
Who cannot join
- patients with stroke occurring more than one month ago
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Wan-Ching Lien
Taipei, None Selected, 100
Wan-Ching Lien, +886223123456, wanchinglien@ntu.edu.tw
About this study
The investigators evaluate the vocal cord movement in patients with acute stroke by ultrasound. The occurrence of choking or aspiration pneumonia will be collected in one year after the index stroke.
Read the detailed description
Post-stroke dysphagia is a common complication for the stroke patient. It may cause aspiration, poor nutrition or even pneumonia; thus, it is crucial for the physicians to evaluate the swallowing function of the stroke patients. However, the evaluation methods nowadays still have some limitations. Water swallowing test is one of the well-known methods, but the test itself would put the patients at risk of aspiration. Furthermore, in order to increase the sensitivity of the water swallowing test, the amount of the water should also be increased; as a consequence, the risk of aspiration will also increase. Fiberoptic endoscopic evaluation of the swallowing and videofluoroscopy have limitations of invasiveness. The laryngeal ultrasound to evaluate the vocal cord movement can be an alternative method, having the characteristics of non-invasiveness and repeat evaluation.
The investigators aim to evaluate the vocal cord movement in patients with acute stroke by ultrasound. The occurrence of choking or aspiration pneumonia will be collected in one year after the index stroke.
- Conditions
- Acute Stroke
- Being tested
- ultrasound
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDiagnostic test
evaluate the vocal cord movement among the stroke patients
| Study group | Role | What they receive |
|---|---|---|
| vocal cord movement among the stroke patients | Experimental | Not described Receives: Diagnostic Test: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of aspiration pneumonia
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start14 Jul 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wan-Ching Lien, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874454
- Sponsor's protocol ID
- 202101143RINA
- Status last verified
- Oct 2026
- First submitted
- 2 May 2021
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No