Validation of Aspiration Risk Assessment in Stroke Units (ARAS)

University of Giessen

Status: Terminated

Conditions: Stroke, Acute

Treatments: Diagnostic Test: Flexible Endoscopic Evaluation of Swallowing; Diagnostic Test: Daniels Water Swallow Test

Study type: Interventional

Funder types: Other

Identifiers

NCT06162910

ARAS-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Clinical swallowing exam

Experimental group

Description:

Patients with acute ischemic stroke

Treatment:

Diagnostic Test: Flexible Endoscopic Evaluation of Swallowing

Diagnostic Test: Daniels Water Swallow Test