Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT06765018
Status:
RECRUITING
Last Update Posted:
2025-01-09
First Post:
2024-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tongue Brush (Orabrush) for Reducing Aspiration Pneumonia in Stroke Patients
Sponsor:
University Hospital Marburg
Organization:
Study Overview
Official Title:
Tongue Brush (Orabrush) for Reducing Aspiration Pneumonia in Stroke Patients
Status:
RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
StrOra
Brief Summary:
The investigators conduct a controlled prospective experimental intervention study to examine whether the use of a tongue brush (Orabrush) can improve the rate of aspiration pneumonia and dysphagia in patients with ischemic stroke. Secondary outcomes include the impact on bacterial tongue colonization, the Tongue Coating Index, and the length of stay of the patients.The patients will be recruited in the Stroke Unit of the Department of Neurology from November 2024 until approximately October 2026.
Detailed Description:
As part of a prospective controlled experimental intervention study, patients with ischemic stroke will be recruited in the Stroke Unit of the University Hospital Marburg, who are admitted between November 2024 and approximately October 2026. The primary objective of this study is to investigate the impact of a tongue brush (Orabrush) on the rate of aspiration pneumonia and dysphagia. Secondary outcomes include the analysis of bacterial tongue colonization, the Tongue Coating Index, and the length of stay of the patients. Key study parameters include the aspiration rate, the EAT-10, the GUSS, a tongue swab, and a photograph of the tongue to determine the Tongue Coating Index. Data will be collected on the day of admission and after a duration of 3-5 days. The study has been approved by the relevant ethics committee.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: