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Validation of Aspiration Risk Assessment in Stroke Units

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06162910
Acronym
ARAS
Enrollment
40
Registered
2023-12-08
Start date
2018-02-01
Completion date
2023-02-28
Last updated
2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Acute

Brief summary

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

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.

Interventions

DIAGNOSTIC_TESTDaniels Water Swallow Test

Clinical water swallow dysphagia screening

Endoscopic evaluation of swallowing function

Sponsors

University of Giessen
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Acute (maximum 7 days old) cerebral infarction detected by cMRI or cCT * Neurological deficits * Written informed consent

Exclusion criteria

* Cerebral hemorrhage * Pre-existing swallowing disorders of other etiologies * Contraindications to clinical swallowing examination (lack of alertness as well as lack of compliance) - Contradictions to FEES (lack of alertness as well as lack of compliance)

Design outcomes

Primary

MeasureTime frameDescription
Penetration-Aspiration-Score (PAS) Penetration-Aspiration-Score (PAS)Immediately after the interventionPenetration-Aspiration-Score, minimum value 1, maximum value 8; higher scores mean worse outcome

Secondary

MeasureTime frameDescription
Functional Oral Intake Scale-German (FOIS-G)Immediately after the interventionFunctional Oral Intake Scale - German Version; minimum value 1, maximum value 7; higher scores mean better outcome

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026