DysphagiaNCT06497790
BJH-SDS Validation of the German Translation
An observational study of Dysphagia and Stroke, Acute, run by University of Giessen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Dysphagia, Stroke, Acute
- What is being tested?
- BJH-SDS Screenint Test and Flexible Endoscopic Evaluation of Swallowing
- How many people
- 570 participants
- Where
- 1 siteGermany
- Study dates
- 15 Apr 2024to 1 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Acute ischemic stroke Patients * General patient popluation * Non-neurologic ICU patients
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Giessen and Marburg, Campus Giessen
Giesen, Hesse, 35392
Tobias Braun, MD, +4964198559233, tobias.braun@neuro.med.uni-giessen.de
About this study
Official title: German Translation and Validation of the Barnes-Jewish-Hospital Stroke Dysphagia Screen (BJH-SDS)
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.
Read the 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.
- Conditions
- Dysphagia, Stroke, Acute
- Being tested
- BJH-SDS Screenint Test, Flexible Endoscopic Evaluation of Swallowing
- Keywords
- Stroke, Dysphagia, Swallowing disorders, FEES, Swallow screening
- Medical subject headings
- Deglutition Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BJH-SDS Screenint TestDiagnostic 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 SwallowingDiagnostic test
Also called FEES
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
| Study group | Role | What they receive |
|---|---|---|
| Acute stroke patients | All patients of the participating clinics who have a suspected diagnosis of stroke Receives: Diagnostic Test: BJH-SDS Screenint Test; Diagnostic Test: Flexible Endoscopic Evaluation of Swallowing | |
| Non-neurologic ICU patients | All patients of the participating clinics who are being treated in intensive care due to a non-neurological disease Receives: Diagnostic Test: BJH-SDS Screenint Test; Diagnostic Test: Flexible Endoscopic Evaluation of Swallowing | |
| Non-neurologic patientes | All patients of the participating clinics who are being treated due to a non-neurological disease Receives: Diagnostic Test: BJH-SDS Screenint Test; Diagnostic Test: Flexible Endoscopic Evaluation of Swallowing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penetration-Aspiration Score
Penetration-Aspiration-Score, minimum value 1, maximum value 8; higher scores mean worse outcome
Measured: Immediately after the intervention
Barthel-Index
Barthel-Index; minimal value 0, maximum value 100; lower values mean worse outcome
Measured: Immediately before the intervention
MRS
Modified Rankin Scale; minimal value 0, maximum value 6; higher values mean worse score
Measured: Immediately before the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start15 Apr 2024
- Primary completion15 Apr 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 570 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tobias Braun, PD MD, Study director, University of GiessenSamra Hamzic, Dr., Principal investigator, University of Giessen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497790
- Sponsor's protocol ID
- BJH-G
- Status last verified
- Jul 2024
- First submitted
- 4 Jul 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- German Translation and Validation of the Barnes-Jewish-Hospital Stroke Dysphagia Screen (BJH-SDS)
- ClinicalTrials.gov ID
- NCT06497790
- Acronym / sponsor ID
- BJH-G
- Conditions
- Dysphagia, Stroke, Acute
- Keywords
- Stroke, Dysphagia, Swallowing disorders, FEES, Swallow screening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 570 participants (estimated)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acute stroke patients | – | Diagnostic Test: BJH-SDS Screenint Test, Diagnostic Test: Flexible Endoscopic Evaluation of SwallowingAll patients of the participating clinics who have a suspected diagnosis of stroke |
| Non-neurologic ICU patients | – | Diagnostic Test: BJH-SDS Screenint Test, Diagnostic Test: Flexible Endoscopic Evaluation of SwallowingAll patients of the participating clinics who are being treated in intensive care due to a non-neurological disease |
| Non-neurologic patientes | – | Diagnostic Test: BJH-SDS Screenint Test, Diagnostic Test: Flexible Endoscopic Evaluation of SwallowingAll patients of the participating clinics who are being treated due to a non-neurological disease |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Acute ischemic stroke Patients * General patient popluation * Non-neurologic ICU patients
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BJH-SDS Screenint TestThe 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) | Diagnostic test | Acute stroke patients, Non-neurologic ICU patients, Non-neurologic patientes |
| Flexible Endoscopic Evaluation of SwallowingAlso: FEESThe 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 | Diagnostic test | Acute stroke patients, Non-neurologic ICU patients, Non-neurologic patientes |
Primary outcome
Penetration-Aspiration Score
Time frame: Immediately after the intervention
Penetration-Aspiration-Score, minimum value 1, maximum value 8; higher scores mean worse outcome
Barthel-Index
Time frame: Immediately before the intervention
Barthel-Index; minimal value 0, maximum value 100; lower values mean worse outcome
MRS
Time frame: Immediately before the intervention
Modified Rankin Scale; minimal value 0, maximum value 6; higher values mean worse score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tobias Braun, PD MD study director
University of Giessen
Samra Hamzic, Dr. principal investigator
University of Giessen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysphagia and Stroke, Acute, run by University of Giessen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tobias Braun, PD MD (+49 6441793517, tobias.braun@neuro.med.uni-giessen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penetration-Aspiration Score (time frame: Immediately after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.