- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04874454
Evaluating Potential Risk of Choking by Laryngeal Ultrasound in Patients With Acute Stroke
Study Overview
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Wan-Ching Lien
- Phone Number: +886988088719
- Email: dtemer17@yahoo.com.tw
Study Contact Backup
- Name: Wan-Ching Lien
- Phone Number: +886223123456
- Email: wanchinglien@ntu.edu.tw
Study Locations
-
-
None Selected
-
Taipei, None Selected, Taiwan, 100
- Recruiting
- Wan-Ching Lien
-
Contact:
- Wan-Ching Lien
- Phone Number: +886223123456
- Email: wanchinglien@ntu.edu.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- acute stroke (in one month) patients
Exclusion Criteria:
- patients with stroke occurring more than one month ago
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: vocal cord movement among the stroke patients
|
evaluate the vocal cord movement among the stroke patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
the incidence of aspiration pneumonia
Time Frame: one year
|
one year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Wan-Ching Lien, National Taiwan University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202101143RINA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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