Stroke, AcuteARASNCT06162910
Validation of Aspiration Risk Assessment in Stroke Units
A study testing Daniels Water Swallow Test and Flexible Endoscopic Evaluation of Swallowing in people with Stroke, Acute, run by University of Giessen at 1 site in Germany.
Trial summary
The purpose of the study is to test the validity of a modified Daniels swallow test. The original test serves as reference method, the swallow endoscopy (FEES) as "gold standard". Furthermore, it will be examined whether the modified Daniels test can be performed by nursing staff. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- Daniels Water Swallow Test and Flexible Endoscopic Evaluation of Swallowing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2018to 28 Feb 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute (maximum 7 days old) cerebral infarction detected by cMRI or cCT
- Neurological deficits
- Written informed consent
Who cannot join
- Cerebral hemorrhage
- Pre-existing swallowing disorders of other etiologies
- Contraindications to clinical swallowing examination (lack of alertness as well as lack of compliance) - Contradictions to FEES (lack of alertness as well as lack of compliance)
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Giessen and Marburg, Campus Giessen
Giesen, Hesse, 35392
About this study
Official title: Aspiration Risk in Stroke Units. Validation of Clinical Investigation Procedures for Risk Stratification
The purpose of the study is to test the validity of a modified Daniels swallow test. The original test serves as reference method, the swallow endoscopy (FEES) as "gold standard".
Furthermore, it will be examined whether the modified Daniels test can be performed by nursing staff. As a reference method, the test will be performed by experienced speech therapists and the swallowing endoscopy (FEES) by speech therapists and/or physicians.
Read the detailed description
For each included patient, the standardized Daniels test is performed by a speech therapist within the first 24 hours after admission, as well as the modified Daniels test by a second speech therapist who is blinded to the result of the first test. This is immediately followed by the administration of the modified Daniels test by a nurse. All investigators are blinded to the results of the preceding water swallow tests. The water swallow tests are not performed by physicians.
Following the water swallow tests, FEES is performed by an examiner (physician or speech therapist) experienced in FEES. The examination is digitally recorded and evaluated by an external examiner (physician or speech therapist) using validated scores.
- Conditions
- Stroke, Acute
- Being tested
- Daniels Water Swallow Test, Flexible Endoscopic Evaluation of Swallowing
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daniels Water Swallow TestDiagnostic test
Clinical water swallow dysphagia screening
Flexible Endoscopic Evaluation of SwallowingDiagnostic test
Also called FEES
Endoscopic evaluation of swallowing function
| Study group | Role | What they receive |
|---|---|---|
| Clinical swallowing exam | Experimental | Patients with acute ischemic stroke Receives: Diagnostic Test: Daniels Water Swallow 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 (PAS) Penetration-Aspiration-Score (PAS)
Penetration-Aspiration-Score, minimum value 1, maximum value 8; higher scores mean worse outcome
Measured: Immediately after the intervention
Secondary outcomes (1)
Functional Oral Intake Scale-German (FOIS-G)
Functional Oral Intake Scale - German Version; minimum value 1, maximum value 7; higher scores mean better outcome
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start1 Feb 2018
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Why it stopped: Interim analysis resulted in reliable figures
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samra Hamzic, PhD, Principal investigator, University Hospital Giessen and Marburg, Campus GiessenTobias Braun, MD, Study director, University Hospital Giessen and Marburg, Campus Giessen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162910
- Sponsor's protocol ID
- ARAS-1
- Acronym
- ARAS
- Status last verified
- Jan 2024
- First submitted
- 30 Nov 2023
- Last updated
- 5 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspiration Risk in Stroke Units. Validation of Clinical Investigation Procedures for Risk Stratification
- ClinicalTrials.gov ID
- NCT06162910
- Acronym / sponsor ID
- ARAS / ARAS-1
- Conditions
- Stroke, Acute
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis resulted in reliable figures
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 8 Dec 2023 (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 purpose of the study is to test the validity of a modified Daniels swallow test. The original test serves as reference method, the swallow endoscopy (FEES) as "gold standard".
Furthermore, it will be examined whether the modified Daniels test can be performed by nursing staff. As a reference method, the test will be performed by experienced speech therapists and the swallowing endoscopy (FEES) by speech therapists and/or physicians.
Detailed description
For each included patient, the standardized Daniels test is performed by a speech therapist within the first 24 hours after admission, as well as the modified Daniels test by a second speech therapist who is blinded to the result of the first test. This is immediately followed by the administration of the modified Daniels test by a nurse. All investigators are blinded to the results of the preceding water swallow tests. The water swallow tests are not performed by physicians.
Following the water swallow tests, FEES is performed by an examiner (physician or speech therapist) experienced in FEES. The examination is digitally recorded and evaluated by an external examiner (physician or speech therapist) using validated scores.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical swallowing exam | Experimental | Diagnostic Test: Daniels Water Swallow Test, Diagnostic Test: Flexible Endoscopic Evaluation of SwallowingPatients with acute ischemic stroke |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute (maximum 7 days old) cerebral infarction detected by cMRI or cCT
- Neurological deficits
- Written informed consent
Key exclusion criteria (3 listed)
- Cerebral hemorrhage
- Pre-existing swallowing disorders of other etiologies
- Contraindications to clinical swallowing examination (lack of alertness as well as lack of compliance) - Contradictions to FEES (lack of alertness as well as lack of compliance)
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 |
|---|---|---|
| Daniels Water Swallow TestClinical water swallow dysphagia screening | Diagnostic test | Clinical swallowing exam |
| Flexible Endoscopic Evaluation of SwallowingAlso: FEESEndoscopic evaluation of swallowing function | Diagnostic test | Clinical swallowing exam |
Primary outcome
Penetration-Aspiration-Score (PAS) Penetration-Aspiration-Score (PAS)
Time frame: Immediately after the intervention
Penetration-Aspiration-Score, minimum value 1, maximum value 8; higher scores mean worse outcome
1 secondary outcome
Functional Oral Intake Scale-German (FOIS-G)
Time frame: Immediately after the intervention
Results and safety
The study was stopped early (reason given: Interim analysis resulted in reliable figures). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
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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.
Samra Hamzic, PhD principal investigator
University Hospital Giessen and Marburg, Campus Giessen
Tobias Braun, MD study director
University Hospital Giessen and Marburg, Campus Giessen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daniels Water Swallow Test and Flexible Endoscopic Evaluation of Swallowing in people with 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 5 Feb 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?
The study was stopped early (reason given: Interim analysis resulted in reliable figures). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penetration-Aspiration-Score (PAS) Penetration-Aspiration-Score (PAS) (time frame: Immediately after the intervention). 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 5 Feb 2024.