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

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04874454
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arm: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Stroke	Diagnostic Test: ultrasound	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Evaluating Potential Risk of Choking by Laryngeal Ultrasound in Patients With Acute Stroke
• Anticipated Study Start Date: Jun 5, 2022
• Anticipated Primary Completion Date: Jun 5, 2022
• Anticipated Study Completion Date: Jun 5, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: vocal cord movement among the stroke patients	Diagnostic Test: ultrasound; evaluate the vocal cord movement among the stroke patients

Outcome Measures

Primary Outcome Measures

1. the incidence of aspiration pneumonia [one year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• acute stroke (in one month) patients

Exclusion Criteria:

• patients with stroke occurring more than one month ago

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wan-Ching Lien	Taipei	None Selected	Taiwan	100

Sponsors and Collaborators

• National Taiwan University Hospital

Investigators

• Principal Investigator: Wan-Ching Lien, National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT04874454
• Other Study ID Numbers: 202101143RINA
• First Posted: May 5, 2021
• Last Update Posted: Jun 7, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of Jun 7, 2022