Tongue Brush (Orabrush) for Reducing Aspiration Pneumonia in Stroke Patients (StrOra)

University Hospital Marburg

Status: Enrolling

Conditions: Ischemic Stroke; Dysphagia After Stroke; Aspiration Pneumonias

Treatments: Device: Tongue Brush (Orabrush)

Study type: Interventional

Funder types: Other

Identifiers

NCT06765018

23-227 BO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 383 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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383 participants in 2 patient groups

Routine Care Group

No Intervention group

Description:

Patients in the Routine Care Group receive standard speech therapy during their inpatient stay.

Tongue Brush Group

Experimental group

Description:

Patients in the Tongue Brush Group receive standard speech therapy and additionally use the tongue brush twice daily for a period of 3-5 days during their inpatient stay.

Treatment:

Device: Tongue Brush (Orabrush)