Validation of Aspiration Risk Assessment in Stroke Units

University of Giessen40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Stroke, Acute

Interventions

Daniels Water Swallow TestDIAGNOSTIC_TEST

Clinical water swallow dysphagia screening

Flexible Endoscopic Evaluation of SwallowingDIAGNOSTIC_TEST

Endoscopic evaluation of swallowing function

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

University Hospital Giessen and Marburg, Campus Giessen

Giesen, Hesse, Germany

Outcomes

Primary Outcomes

Penetration-Aspiration-Score (PAS) Penetration-Aspiration-Score (PAS)

Penetration-Aspiration-Score, minimum value 1, maximum value 8; higher scores mean worse outcome

Time frame: Immediately after the intervention

Secondary Outcomes

Functional Oral Intake Scale-German (FOIS-G)

Functional Oral Intake Scale - German Version; minimum value 1, maximum value 7; higher scores mean better outcome

Time frame: Immediately after the intervention

Data from ClinicalTrials.gov

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