BJH-SDS Validation of the German Translation

Recruiting

• Conditions: Dysphagia; Stroke, Acute

• Registration Number: NCT06497790
• Lead Sponsor: University of Giessen

Brief Summary

The first object of the study is the validation of a translation of the Barnes-Jewish Hospital Stroke Dysphagia Screen with determination of sensitivity, specificity, interrater reliability (especially between different professional groups) and criterion validity.

If the German translation proves to be suitable, it will also be validated on general neurological patients, i.e. patients on a neurological ward without a stroke.

Detailed Description

Stroke is now the second most common cause of death worldwide. Dysphagia is described as a direct consequence of cerebral infarction in at least 50% of stroke patients in the acute phase \[2\]. It often leads to aspiration pneumonia, which is the most important secondary complication in stroke unit. Within one year after a stroke, around 20% of dysphagia patients die as a result of aspiration pneumonia . In addition, dysphagia causes numerous other secondary complications (malnutrition, exsiccosis) and associated high costs for the healthcare system.

Numerous screening procedures have been developed in recent years. These are mostly based on a swallowing test with water after testing various input requirements. There are also multi-consistency tests that include liquids as well as pulpy and solid consistencies. The sensitivity of the tests is usually at least 85% with moderate specificity, which is due to the inability to detect silent aspiration by non-instrumental diagnostics. In addition, the implementation of the screening procedures is usually only evaluated by the professional group of speech therapists.

One of these screening procedures is the Barnes-Jewish-Hospital Stroke Dysphagia Screen (BJH-SDS). In our opinion, this test is very well suited as a screening procedure, as it has good sensitivity (94%) and specificity (64%), is validated for all professional groups and takes little time. In brief, it includes an assessment of sufficient consciousness (Glasgow Coma Scale over 13 points), a check for facial paresis, soft palate paresis and tongue paresis followed by a water swallow test with 90 ml of water if the previous points are assessed as normal. The water swallow test checks for signs of aspiration (throat clearing, coughing or a change in voice quality) However, the BJH-SDS is not yet available in German. The aim of this research project is therefore to translate the BJH-SDS into German (BJH-SDS-G) and validate it as the gold standard using flexible endoscopic swallowing examination (FEES) and then use it routinely in our clinics. This will be followed by validation in general neurological patients (without stroke) so that the BJH-SDS can also be used reliably in this patient population.

Study Timeline

• Study Start: 2024-04-15
• Status Verified: 2024-07
• Study First Submitted: 2024-07-04
• Study First Submitted QC: 2024-07-04
• Last Update Submitted: 2024-07-04
• Study First Posted: 2024-07-12
• Last Update Posted: 2024-07-12
• Primary Completion: 2026-04-15
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 570

Inclusion Criteria

• All stroke patients in the neurology department of the Lahn-Dill Clinic in Wetzlar and the stroke unit of the Bürgerhospital in Friedberg and the neurologic ICU of the University Hospital in Giessen are to be screened with the BJH-SDS-G after appropriate information has been provided.

Exclusion Criteria

• Exclusion criteria are a lack of informed consent, contraindications to an FEES examination, a history of stroke, pre-existing dysphagia or a disease that may be associated with dysphagia (e.g. ENT tumors, Parkinson's disease, neuromuscular diseases).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Penetration-Aspiration Score	Immediately after the intervention	Penetration-Aspiration-Score, minimum value 1, maximum value 8; higher scores mean worse outcome
MRS	Immediately before the intervention	Modified Rankin Scale; minimal value 0, maximum value 6; higher values mean worse score
Barthel-Index	Immediately before the intervention	Barthel-Index; minimal value 0, maximum value 100; lower values mean worse outcome

Trial Locations

Locations (1)

University Hospital Giessen and Marburg, Campus Giessen; 🇩🇪 Giesen, Hessen, Germany