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NCT Number: NCT06497790

BJH-SDS Validation of the German Translation

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Giessen and Marburg, Campus Giessen

Giesen, Hesse, 35392, Germany

Location status: Recruiting

Location contact

Tobias Braun, MD

CONTACT

[email protected]

+4964198559233

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

BJH-SDS Screenint Test

Diagnostic Test

The test includes the assessment of a sufficient level of 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)

Flexible Endoscopic Evaluation of Swallowing

Diagnostic Test

The FEES evaluates anatomical changes, functional disorders of the visible structures (e.g. recurrent paresis), saliva management, penetration and aspiration of food boluses in order to draw conclusions about the underlying pathomechanism of dysphagia. It is an established standard diagnostic procedure for stroke patients and, in addition to the diagnosis of dysphagia, also enables pathomechanism-guided therapy by speech therapists

Other names: FEES

Primary outcomes

  1. Penetration-Aspiration Score

    Time frame: Immediately after the intervention

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

  2. Barthel-Index

    Time frame: Immediately before the intervention

    Barthel-Index; minimal value 0, maximum value 100; lower values mean worse outcome

  3. MRS

    Time frame: Immediately before the intervention

    Modified Rankin Scale; minimal value 0, maximum value 6; higher values mean worse score

Study contacts

Contact information is provided by the study sponsor or research team.

Tobias Braun, PD MD

CONTACT

[email protected]

+49 6441793517

Sponsors and collaborators

Lead sponsor

University of Giessen

Other

Registry information

Official study title

German Translation and Validation of the Barnes-Jewish-Hospital Stroke Dysphagia Screen (BJH-SDS)

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 12, 2024
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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