Validation of Aspiration Risk Assessment in Stroke Units

Study Overview
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Brief Summary
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The purpose of the study is to test the validity of a modified Daniels swallow test. The original test serves as reference method, the swallow endoscopy (FEES) as gold standard. Furthermore, it will be examined whether the modified Daniels test can be performed by nursing staff. As a reference method, the test will be performed by experienced speech therapists and the swallowing endoscopy (FEES) by speech therapists and/or physicians.

Detailed Description
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For each included patient, the standardized Daniels test is performed by a speech therapist within the first 24 hours after admission, as well as the modified Daniels test by a second speech therapist who is blinded to the result of the first test. This is immediately followed by the administration of the modified Daniels test by a nurse. All investigators are blinded to the results of the preceding water swallow tests. The water swallow tests are not performed by physicians. Following the water swallow tests, FEES is performed by an examiner (physician or speech therapist) experienced in FEES. The examination is digitally recorded and evaluated by an external examiner (physician or speech therapist) using validated scores.

Official Title
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Aspiration Risk in Stroke Units. Validation of Clinical Investigation Procedures for Risk Stratification

Conditions
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Stroke, Acute

Intervention / Treatment
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* Diagnostic Test: Daniels Water Swallow Test
* Diagnostic Test: Flexible Endoscopic Evaluation of Swallowing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients in whom an acute (maximum 7 days old) cerebral infarction was detected by cMRI or cCT or a cerebral hemorrhage was excluded by image diagnosis and in whom neurological deficits are present. An informed consent must be available for included patients. Exclusion Criteria: Pre-existing swallowing disorders of other etiologies or contraindications to clinical swallowing examination or to FEES will result in exclusion from the study. Contraindications are: lack of alertness as well as lack of compliance.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Patients with acute ischemic stroke | Diagnostic Test: Daniels Water Swallow Test<br>* Clinical water swallow dysphagia screening<br>Diagnostic Test: Flexible Endoscopic Evaluation of Swallowing<br>* Endoscopic evaluation of swallowing function<br>* Other names: FEES;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PAS Score | Penetration-Aspiration-Score | Immediately after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FOIS-G | Functional Oral Intake Scale - German Version | Immediately after the intervention |