BJH-SDS Validation of the German Translation

NCT06497790 | Recruiting

• 1 other identifier: BJH-G
• Study Type: observational
• Target: 570
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphagia; Stroke, Acute

Keywords

Stroke; Dysphagia; Swallowing disorders; FEES; Swallow screening

Outcome Measures

Primary Outcomes (3)

• Penetration-Aspiration Score

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

  Immediately after the intervention

• Barthel-Index

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

  Immediately before the intervention

• MRS

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

  Immediately before the intervention

Study Arms (3)

Acute stroke patients

All patients of the participating clinics who have a suspected diagnosis of stroke

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

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

Diagnostic Test: BJH-SDS Screenint Test; Diagnostic Test: Flexible Endoscopic Evaluation of Swallowing

Interventions

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)

Acute stroke patients; Non-neurologic ICU patients; Non-neurologic patientes

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

Also known as: FEES

Acute stroke patients; Non-neurologic ICU patients; Non-neurologic patientes

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Giessen: lead

Study Sites (1)

University Hospital Giessen and Marburg, Campus Giessen

Giesen, Hesse, 35392, Germany

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders; Stroke

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Tobias Braun, PD MD

  University of Giessen

  STUDY DIRECTOR

• Samra Hamzic, Dr.

  University of Giessen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tobias Braun, PD MD

CONTACT

+49 6441793517; tobias.braun@neuro.med.uni-giessen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 12, 2024
• Study Start: April 15, 2024
• Primary Completion: April 15, 2026
• Study Completion: May 1, 2026
• Last Updated: July 12, 2024

Record last verified: 2024-07

Locations

DE (1)