Clinical trial NCT06765018: Tongue Brush (Orabrush) for Reducing Aspiration Pneumonia in Stroke Patients
Official title: Tongue Brush (Orabrush) for Reducing Aspiration Pneumonia in Stroke Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dysphagia After Stroke
Aspiration Pneumonias
Ischemic Stroke
Keywords: Dysphagia after stroke
Aspiration Pneumonias
Tongue Coating Index
Bacterial Tongue Colonization
Ischemic Stroke
Lead sponsor: University Hospital Marburg
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 383
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* ischemic stroke and admission on the stroke unit at the University Hospital Marburg
* minimum age: 18 years
* patient is able to consent
* consent has been obtained

Exclusion Criteria:

* surgery in the oral-pharyngeal region
* irradiated patient with a history of tumor in the head and neck region
* missing compliance
* intake of medications with saliva-altering side effects, existing desire to have children, or pregnancy

Primary outcomes:
measure: Rate of Aspiration Pneumonias
timeFrame: From the date of first admission until discharge, with the occurrence of aspiration, within max. 4 weeks pneumonia documented at any point during the inpatient stay.
measure: Severity of dysphagia measured by EAT-10 [score from 0-40]
timeFrame: EAT-10 is assessed on the day of admission and after a period of 3-5 days.
measure: Severity of dysphagia measured by GUSS [score from 0-20]
timeFrame: GUSS is assessed on the day of admission and after a period of 3-5 days.
Secondary outcomes:
measure: Winkel Tongue Coating Index [Score from 0 to 12]
timeFrame: The WTCI of the patients is determined on the day of admission and after 3-5 days.
measure: Microbiological quantification of the tongue's bacterial load through the determination of colony-forming units (CFU)
timeFrame: Bacterial tongue colonization is assessed in the patients through swabbing on the day of admission and after 3-5 days.
measure: Length of in-hospital stay in days
timeFrame: Duration of in-hospital stay, measured from the admission date to the discharge date, during the inpatient treatment period. The average length of stay is approximately 6 days, so a maximum time frame of 30 days is chosen for the survey.
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: University Hospital Marburg
state: Hessen
Study officials:
References: