BJH-SDS Validation of the German Translation
- Conditions
- DysphagiaStroke, Acute
- Interventions
- Diagnostic Test: BJH-SDS Screenint TestDiagnostic Test: Flexible Endoscopic Evaluation of Swallowing
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 570
- All stroke patients in the neurology department of the Lahn-Dill Clinic in Wetzlar and the stroke unit of the BĂŒrgerhospital 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 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
- Arm && Interventions
Group Intervention Description Non-neurologic ICU patients BJH-SDS Screenint Test All patients of the participating clinics who are being treated in intensive care due to a non-neurological disease Non-neurologic ICU patients Flexible Endoscopic Evaluation of Swallowing All patients of the participating clinics who are being treated in intensive care due to a non-neurological disease Acute stroke patients BJH-SDS Screenint Test All patients of the participating clinics who have a suspected diagnosis of stroke Acute stroke patients Flexible Endoscopic Evaluation of Swallowing All patients of the participating clinics who have a suspected diagnosis of stroke Non-neurologic patientes Flexible Endoscopic Evaluation of Swallowing All patients of the participating clinics who are being treated due to a non-neurological disease Non-neurologic patientes BJH-SDS Screenint Test All patients of the participating clinics who are being treated due to a non-neurological disease
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospital Giessen and Marburg, Campus Giessen
đ©đȘGiesen, Hessen, Germany