NCT06162910

Validation of Aspiration Risk Assessment in Stroke Units

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Giessen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke, Acute

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Daniels Water Swallow Test	Clinical water swallow dysphagia screening
DIAGNOSTIC_TEST	Flexible Endoscopic Evaluation of Swallowing	Endoscopic evaluation of swallowing function

Timeline

• Start date: 2018-02-01
• Primary completion: 2023-02-28
• Completion: 2023-02-28
• First posted: 2023-12-08
• Last updated: 2024-02-05

Locations

1 site across 1 country: Germany