Ignite Creation Date:
2024-07-17 @ 10:55 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06497790
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-04
Brief Title:
BJH-SDS Validation of the German Translation
Sponsor:
University of Giessen
Organization:
University of Giessen
Study Overview
Official Title:
German Translation and Validation of the Barnes-Jewish-Hospital Stroke Dysphagia Screen BJH-SDS
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie patients on a neurological ward without a stroke
If the German translation proves to be suitable it will also be validated on general neurological patients ie 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None