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Interim analysis resulted in reliable figures
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical swallowing exam | Experimental | Patients with acute ischemic stroke |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daniels Water Swallow Test | Diagnostic Test | Clinical water swallow dysphagia screening |
|
| Measure | Description | Time Frame |
|---|---|---|
| Penetration-Aspiration-Score (PAS) Penetration-Aspiration-Score (PAS) | Penetration-Aspiration-Score, minimum value 1, maximum value 8; higher scores mean worse outcome | Immediately after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Oral Intake Scale-German (FOIS-G) | Functional Oral Intake Scale - German Version; minimum value 1, maximum value 7; higher scores mean better outcome | Immediately after the intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samra Hamzic, PhD | University Hospital Giessen and Marburg, Campus Giessen | Principal Investigator |
| Tobias Braun, MD | University Hospital Giessen and Marburg, Campus Giessen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Giessen and Marburg, Campus Giessen | Giesen | Hesse | 35392 | Germany |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Flexible Endoscopic Evaluation of Swallowing | Diagnostic Test | Endoscopic evaluation of swallowing function |
|
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |