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Evaluating Potential Risk of Choking by Laryngeal Ultrasound in Patients With Acute Stroke

Primary Purpose

Acute Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
ultrasound
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Stroke

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • acute stroke (in one month) patients

Exclusion Criteria:

  • patients with stroke occurring more than one month ago

Sites / Locations

  • Wan-Ching LienRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

vocal cord movement among the stroke patients

Arm Description

Outcomes

Primary Outcome Measures

the incidence of aspiration pneumonia

Secondary Outcome Measures

Full Information

First Posted
May 2, 2021
Last Updated
July 14, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04874454
Brief Title
Evaluating Potential Risk of Choking by Laryngeal Ultrasound in Patients With Acute Stroke
Official Title
Evaluating Potential Risk of Choking by Laryngeal Ultrasound in Patients With Acute Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2023 (Actual)
Primary Completion Date
July 14, 2023 (Anticipated)
Study Completion Date
June 5, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stroke

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
vocal cord movement among the stroke patients
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
ultrasound
Intervention Description
evaluate the vocal cord movement among the stroke patients
Primary Outcome Measure Information:
Title
the incidence of aspiration pneumonia
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: acute stroke (in one month) patients Exclusion Criteria: patients with stroke occurring more than one month ago
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wan-Ching Lien
Phone
+886223123456
Email
wanchinglien@ntu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Wan-Ching Lien
Phone
+886988088719
Email
dtemer17@yahoo.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wan-Ching Lien
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wan-Ching Lien
City
Taipei
State/Province
None Selected
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wan-Ching Lien
Phone
+886223123456
Email
wanchinglien@ntu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluating Potential Risk of Choking by Laryngeal Ultrasound in Patients With Acute Stroke

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