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BJH-SDS Validation of the German Translation

ConditionsDysphagiaStroke, Acute
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorUniversity of Giessen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 population

* Acute ischemic stroke Patients * General patient popluation * Non-neurologic ICU patients

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

570 Participants
are divided into 3 treatment groups
Group A: Acute stroke patients2 interventions
Group B: Non-neurologic ICU patients2 interventions
Group C: Non-neurologic patientes2 interventions

Trial outcomes

Primary outcomes

1

Penetration-Aspiration Score

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

Time frame
Immediately after the intervention
2

Barthel-Index

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

Time frame
Immediately before the intervention
3

MRS

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

Time frame
Immediately before the intervention

Secondary outcomes

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

University Hospital Giessen and Marburg, Campus GiessenRecruiting35392, Giesen, HesseGermanyGermany

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Giessen

Lead sponsor

Source ClinicalTrials.gov
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