Validation of Aspiration Risk Assessment in Stroke Units

Stroke, Acute Clinical Trial

— ARAS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT06162910
• Other study ID #: ARAS-1
• Status: Terminated
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: February 28, 2023

Study information

• Verified date: January 2024
• Source: University of Giessen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

Diagnostic Test:
• Daniels Water Swallow Test
Clinical water swallow dysphagia screening
• Flexible Endoscopic Evaluation of Swallowing
Endoscopic evaluation of swallowing function

Locations

Country	Name	City	State
Germany	University Hospital Giessen and Marburg, Campus Giessen	Giesen	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
University of Giessen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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