GEBS - A screening tool for swallowing disorders in geriatric patients
| ISRCTN | ISRCTN11581931 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11581931 |
| ClinicalTrials.gov number | Nil Known |
| Secondary identifying numbers | 201901 |
- Submission date
- 23/03/2021
- Registration date
- 24/03/2021
- Last edited
- 19/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English Summary
Background and study aims
Ageing causes changes in the swallowing process. More time is needed to chew, transport and prepare the food for swallowing inside the mouth and to actually swallow. This process can be disordered, known as dysphagia. Dysphagia can cause complications such as too little intake of food and water but also lead to an inflammation of the lung tissue when food or drinks enter the airways and coughing can not expel it completely. Diseases that are linked with dysphagia are Stroke, Morbus Parkinson and cognitive diseases - all those are more common in older people. It is therefore important to detect people with swallowing disorders early in order to treat the swallowing process, making it safe to eat and drink again. There are no published screening tools that have been developed for older people, making it hard to correctly diagnose those in need of further investigation and treatment. This study aims to close this gap by providing a safe, short and easy screening tool for the detection of swallowing disorders in people aged 75 years and older.
Who can participate?
People admitted at one of the two study sites within the time of recruitment aged 75 years and older who have no history of head and neck cancers or severe stroke, who have a regular breathing mechanism (no tracheostoma, meaning not breathing through their neck) and who don't suffer from advanced dementia.
What does the study involve?
By participating patients agree to have the new test (GEBS) administered to them, this includes a few questions followed by a few sips of water alternating with saying "AH" in a loud voice as well as eating a small bowl of pureed food. Within a week of that initial test, they will then have an instrumental swallowing examination, where a small endoscope with a camera is passed through the nose into the back of the mouth. Once this is in place participants will be asked to swallow liquid, pureed and solid foods which have been colored with non-toxic food colouring.
What are the possible benefits and risks of participating?
The possible benefits are a thorough documentation of the swallowing process at the present time, which is a valuable baseline even for healthy people. In case there is dysphagia detected because of study participation, patients will benefit from early treatment. Risks are very low, mainly discomfort and possible nose bleed during the endoscopic evaluation of swallowing. A few cases of decreased blood pressure or changes in heart rhythm have been reported, but none of those required any medical assistance.
Where is the study run from?
The study is run as the dissertation project of the main researcher at the Paracelsus Medical University Salzburg (Austria)
When is the study starting and how long is it expected to run for?
April 2019 to September 2024
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Susanne M. Javorszky, susanne.javorszky@stud.pmu.ac.at
Contact information
Public
Institut für Pflegewissenschaft und -praxis
Strubergasse 21
Salzburg
5020
Austria
 ORCID ID |
0000-0003-4219-5857 |
|---|---|
| Phone | +43 69981936162 |
| susanne.javorszky@stud.pmu.ac.at |
Scientific
Institut für Pflegewissenschaft und -praxis
Strubergasse 21
Salzburg
5020
Austria
| Phone | +43 69981936162 |
|---|---|
| susanne.javorszky@stud.pmu.ac.at |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet (in German) |
| Scientific title | Validation of the Geriatric Bedside Swallow Screen |
| Study acronym | GEBS |
| Study hypothesis | The screening tool GEBS is sensitive to the presence of dysphagia |
| Ethics approval(s) | 1. Approved 07/03/2022, Ethics board of the city of Vienna (Ethikkommission der Stadt Wien, 1030 Wien, Thomas-Klestil-Platz 8/1, Austria; +43 1 4000 87754; ethikkommission@m15.magwien.gv.at), ref: EK-21-212-1021 2. Approved 14/06/2022, Ethikkommission für das Bundesland Salzburg (Sebastian-Stief-Gasse 2, 5020 Salzburg; +43 662 8042-2375; ethikkommission@salzburg.gv.at), ref: 1040/2022 |
| Condition | Early detection of dysphagia in geriatric patients |
| Intervention | Observational trial using a comparison between the index test (GEBS) and an internationally standardised and well documented, reliable instrumental swallowing test (FEES) to calculate the sensitivity and specificity of the index test Index test, GEBS, is applied (anamnesis plus observation of liquid and bolus intake with structured documentation). Within 6 days FEES (flexible endoscopic evaluation of swallowing - endoscope is lead through the nose so the larynx can be observed while swallowing different types of boli) is applied for objective diagnosis of dysphagia (and severity, if dysphagia is diagnosed). |
| Intervention type | Other |
| Primary outcome measure | Presence/absence of dysphagia measured using: 1. Index Test GEBS will be measured as PASS/FAIL at the beginning of participation 2. FEES using the Penetration-Aspiration Scale (PAS) within one week of the GEBS |
| Secondary outcome measures | Inter-Rater Reliability will be measured by applying the GEBS twice within three days by two different observers |
| Overall study start date | 10/04/2019 |
| Overall study end date | 30/09/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 75 Years |
| Sex | Both |
| Target number of participants | 100 |
| Participant inclusion criteria | 1. Aged 75 years or older 2. Admitted at one of the two study sites at the time of data collection 3. Able to give informed consent |
| Participant exclusion criteria | 1. Tracheostoma 2. Cognitive desease (Diagnosis of dementia) with MMSE 20 or lower 3. Anamnesis of stroke with NIHSS of 20 or higher 4. Anamnesis of neck-throat-cancer with structural changes in the anatomy relevant for swallowing |
| Recruitment start date | 01/07/2022 |
| Recruitment end date | 31/07/2024 |
Locations
Countries of recruitment
- Austria
Study participating centres
Ignaz-Harrer-Straße 79
Salzburg
5020
Austria
Wien
1160
Austria
Sponsor information
University/education
Institut für Pflegewissenschaft und -praxis
Strubergasse 21
Salzburg
5020
Austria
| Phone | +43 (0)662 24200 |
|---|---|
| office@pmu.ac.at | |
| Website | http://www.pmu.ac.at/ |
"ROR" |
https://ror.org/03z3mg085 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/03/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication of study protocol followed by publication of results in a high-impact peer-reviewed journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 06/04/2021 | No | No | ||
| Protocol article | 11/08/2023 | 14/08/2023 | Yes | No |
Additional files
- ISRCTN11581931_PROTOCOL_2020.pdf
- Uploaded 06/04/2021
Editorial Notes
19/07/2024: The overall end date was changed from 31/03/2024 to 30/09/2024.
14/05/2024: The recruitment end date was changed from 31/05/2024 to 31/07/2024.
18/03/2024: The recruitment end date was changed from 20/03/2023 to 31/05/2024.
14/08/2023: Publication reference added.
20/03/2023: The following changes were made to the trial record:
1. The overall end date was changed from 31/03/2023 to 31/03/2024.
2. The intention to publish date was changed from 01/03/2024 to 01/03/2025.
3. The plain English summary was updated to reflect these changes.
28/06/2022: The following changes were made to the trial record:
1. The second ethics approval was added.
2. The recruitment start date has been changed from 01/03/2022 to 01/07/2022.
18/03/2022: The following changes were made to the trial record:
1. The ethics approval was added.
2. The participant level data sharing plan was added.
19/01/2022: The recruitment start date has been changed from 01/01/2022 to 01/03/2022.
16/11/2021: The recruitment start date has been changed from 01/11/2021 to 01/01/2022.
17/09/2021: The recruitment start date was changed from 01/09/2021 to 01/11/2021.
06/04/2021: Uploaded protocol (not peer reviewed).
24/03/2021: Trial's existence confirmed by Paracelsus University.
