Acute StrokeTEDRASNCT04302883
Transesophageal Echocardiography: Dysphagia Risk in Acute Stroke (T.E.D.R.A.S. Trial)
A study testing Transesophageal Echocardiography (TEE) and Flexible Endoscopic Evaluation of Swallowing in people with Acute Stroke and Dysphagia, run by University of Giessen at 1 site in Germany.
Trial summary
The prevalence of dysphagia in acute stroke patients undergoing transesophageal echocardiography (TEE) is unknown. The aim of this study was to assess for the first time whether TEE has a negative influence on swallowing in acute stroke patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke, Dysphagia, Swallowing Disorder
- What is being tested?
- Transesophageal Echocardiography (TEE) and Flexible Endoscopic Evaluation of Swallowing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteGermany
- Study dates
- 12 Jun 2013to 1 Oct 2019
- 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 stroke (max. 7 days post-onset) as displayed by a cranial computed tomography (CT) or magnetic resonance imaging (MRI)
- written informed consent either by patients themselves or by a legal representative
- indication for TEE
Who cannot join
- brain hemorrhage
- either pre-existing neurogenic dysphagia or
- head-and-neck cancer induced dysphagia
- dementia
- aphasia with an impairment in language comprehension
Trial locations and contacts
1 site in 1 country.
About this study
The prevalence of dysphagia in acute stroke patients undergoing transesophageal echocardiography (TEE) is unknown. The aim of this study was to assess for the first time whether TEE has a negative influence on swallowing in acute stroke patients.
Read the detailed description
Dysphagia is common in patients with acute stroke and deteriorates the overall outcome (1). Transesophageal echocardiography (TEE) is a routine examination in the diagnostic workup of stroke etiology. In cardiac surgery it is known as cause of postoperative dysphagia (2).
Using flexible endoscopic evaluation of swallowing (FEES) T.E.D.R.A.S., as a prospective, blinded, randomized and controlled study, includes patients in two groups in order to test the influence of TEE on swallowing in acute stroke: an intervention group and a control group. FEES is performed for analysis of swallowing in the intervention group (1) one day before TEE, (2) 2-4 hours after TEE, (3) 24 hours after TEE. In the control group FEES is performed on three consecutive days with TEE taking place any time after the last FEES. Validated scores assess dysphagia severity in both groups.
- Conditions
- Acute Stroke, Dysphagia, Swallowing Disorder
- Being tested
- Transesophageal Echocardiography (TEE), Flexible Endoscopic Evaluation of Swallowing
- Medical subject headings
- Stroke, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transesophageal Echocardiography (TEE)Diagnostic test
Ultrasound of heart chambers via esophagus
Flexible Endoscopic Evaluation of SwallowingDiagnostic test
Endoscopical swallowing study
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | TEE FEES Receives: Diagnostic Test: Transesophageal Echocardiography (TEE); Diagnostic Test: Flexible Endoscopic Evaluation of Swallowing |
| Control group | Active comparator | FEES Receives: Diagnostic Test: Transesophageal Echocardiography (TEE); Diagnostic Test: Flexible Endoscopic Evaluation of Swallowing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Secretion severity
Change in presence and severity of dysphagia examined via FEES and scored by Murray´s Secretions Severity Rating Scale Minimum value: 0 Maximum value: 3 Higher scores mean worse outcome
Measured: Intervention group: One day before TEE; Control group: At least three days before TEE
Secretion severity
Change in presence and severity of dysphagia examined via FEES and scored by Murray´s Secretions Severity Rating Scale Minimum value: 0 Maximum value: 3 Higher scores mean worse outcome
Measured: Intervention group: 2-4 hours after TEE; Control group: At least two days before TEE
Secretion severity
Change in presence and severity of dysphagia examined via FEES and scored by Murray´s Secretions Severity Rating Scale Minimum value: 0 Maximum value: 3 Higher scores mean worse outcome
Measured: Intervention group: 24 hours after TEE; Control group: At least one day before TEE
Dysphagia severity
Change in presence and severity of dysphagia examined via FEES and scored by Rosenbek´s Penetration-Aspiration-Scale Minimum value: 1 Maximum value: 8 Higher scores mean worse outcome
Measured: Intervention group: One day before TEE; Control group: At least three days before TEE
Dysphagia severity
Change in presence and severity of dysphagia examined via FEES and scored by Rosenbek´s Penetration-Aspiration-Scale Minimum value: 1 Maximum value: 8 Higher scores mean worse outcome
Measured: Intervention group: 2-4 hours after TEE; Control group: At least two days before TEE
Dysphagia severity
Change in presence and severity of dysphagia examined via FEES and scored by Rosenbek´s Penetration-Aspiration-Scale Minimum value: 1 Maximum value: 8 Higher scores mean worse outcome
Measured: Intervention group: 24 hours after TEE; Control group: At least one day before TEE
Pharyngeal residue severity
Change in presence and severity of dysphagia examined via FEES and scored by Yale Pharyngeal Residue Severity Rating Scale Minimum value: 1 Maximum value: 5 Higher scores mean worse outcome
Measured: Intervention group: One day before TEE; Control group: At least three days before TEE
Pharyngeal residue severity
Change in presence and severity of dysphagia examined via FEES and scored by Yale Pharyngeal Residue Severity Rating Scale Minimum value: 1 Maximum value: 5 Higher scores mean worse outcome
Measured: Intervention group: 2-4 hours after TEE; Control group: At least two days before TEE
Pharyngeal residue severity
Change in presence and severity of dysphagia examined via FEES and scored by Yale Pharyngeal Residue Severity Rating Scale Minimum value: 1 Maximum value: 5 Higher scores mean worse outcome
Measured: Intervention group: 24 hours after TEE; Control group: At least one day before TEE
Secondary outcomes (2)
Stroke severity
Quantification of stroke severity via National Institutes of Health Stroke Scale (NIHSS):
Minimum value: 0 Maximum value: 42 Higher scores mean worse outcome
Measured: At the day of admission to hospital and up to 2 weeks after TEE
Degree of disability after stroke
Measuring the degree of disability or dependance of stroke survivors as measured by the Modified Rankin Scale (MRS):
Minimum value: 0 Maximum value: 6 Higher scores mean worse outcome
Measured: At the day of admission to hospital and up to 2 weeks after TEE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start12 Jun 2013
- Primary completion5 Sep 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute StrokeStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tibo Gerriets, MD, Principal investigator, Department of Neurology, University Hospital Giessen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04302883
- Sponsor's protocol ID
- TEDRAS-1
- Acronym
- TEDRAS
- Status last verified
- Feb 2020
- First submitted
- 19 Feb 2020
- Last updated
- 10 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barer DH. The natural history and functional consequences of dysphagia after hemispheric stroke. J Neurol Neurosurg Psychiatry. 1989 Feb;52(2):236-41. doi: 10.1136/jnnp.52.2.236.
PubMed 2564884Hogue CW Jr, Lappas GD, Creswell LL, Ferguson TB Jr, Sample M, Pugh D, Balfe D, Cox JL, Lappas DG. Swallowing dysfunction after cardiac operations. Associated adverse outcomes and risk factors including intraoperative transesophageal echocardiography. J Thorac Cardiovasc Surg. 1995 Aug;110(2):517-22. doi: 10.1016/S0022-5223(95)70249-0.
PubMed 7637370Hamzic S, Juenemann M, Braun T, Piayda K, Bauer P, Sossalla S, Gerriets T, Khilan H, Butz M, Schramm P, Omar OA. TEDRAS II - transesophageal echocardiography as dysphagia risk in the acute phase of stroke-protocol for a prospective pilot observational trial. Trials. 2025 Oct 27;26(1):445. doi: 10.1186/s13063-025-09065-5.
PubMed 41146308
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transesophageal Echocardiography: Dysphagia Risk in Acute Stroke (T.E.D.R.A.S. Trial)
- ClinicalTrials.gov ID
- NCT04302883
- Acronym / sponsor ID
- TEDRAS / TEDRAS-1
- Conditions
- Acute Stroke, Dysphagia, Swallowing Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Study start
- 12 Jun 2013 (actual)
- Primary completion
- 5 Sep 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 10 Mar 2020 (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 prevalence of dysphagia in acute stroke patients undergoing transesophageal echocardiography (TEE) is unknown. The aim of this study was to assess for the first time whether TEE has a negative influence on swallowing in acute stroke patients.
Detailed description
Dysphagia is common in patients with acute stroke and deteriorates the overall outcome (1). Transesophageal echocardiography (TEE) is a routine examination in the diagnostic workup of stroke etiology. In cardiac surgery it is known as cause of postoperative dysphagia (2).
Using flexible endoscopic evaluation of swallowing (FEES) T.E.D.R.A.S., as a prospective, blinded, randomized and controlled study, includes patients in two groups in order to test the influence of TEE on swallowing in acute stroke: an intervention group and a control group. FEES is performed for analysis of swallowing in the intervention group (1) one day before TEE, (2) 2-4 hours after TEE, (3) 24 hours after TEE. In the control group FEES is performed on three consecutive days with TEE taking place any time after the last FEES. Validated scores assess dysphagia severity in both groups.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Diagnostic Test: Transesophageal Echocardiography (TEE), Diagnostic Test: Flexible Endoscopic Evaluation of SwallowingTEE FEES |
| Control group | Active comparator | Diagnostic Test: Transesophageal Echocardiography (TEE), Diagnostic Test: Flexible Endoscopic Evaluation of SwallowingFEES |
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 stroke (max. 7 days post-onset) as displayed by a cranial computed tomography (CT) or magnetic resonance imaging (MRI)
- written informed consent either by patients themselves or by a legal representative
- indication for TEE
Key exclusion criteria (5 listed)
- brain hemorrhage
- either pre-existing neurogenic dysphagia or
- head-and-neck cancer induced dysphagia
- dementia
- aphasia with an impairment in language comprehension
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 |
|---|---|---|
| Transesophageal Echocardiography (TEE)Ultrasound of heart chambers via esophagus | Diagnostic test | Control group, Intervention group |
| Flexible Endoscopic Evaluation of SwallowingEndoscopical swallowing study | Diagnostic test | Control group, Intervention group |
Primary outcome
Secretion severity
Time frame: Intervention group: One day before TEE; Control group: At least three days before TEE
Change in presence and severity of dysphagia examined via FEES and scored by Murray´s Secretions Severity Rating Scale Minimum value: 0 Maximum value: 3 Higher scores mean worse outcome
Secretion severity
Time frame: Intervention group: 2-4 hours after TEE; Control group: At least two days before TEE
Change in presence and severity of dysphagia examined via FEES and scored by Murray´s Secretions Severity Rating Scale Minimum value: 0 Maximum value: 3 Higher scores mean worse outcome
Secretion severity
Time frame: Intervention group: 24 hours after TEE; Control group: At least one day before TEE
Change in presence and severity of dysphagia examined via FEES and scored by Murray´s Secretions Severity Rating Scale Minimum value: 0 Maximum value: 3 Higher scores mean worse outcome
Dysphagia severity
Time frame: Intervention group: One day before TEE; Control group: At least three days before TEE
Change in presence and severity of dysphagia examined via FEES and scored by Rosenbek´s Penetration-Aspiration-Scale Minimum value: 1 Maximum value: 8 Higher scores mean worse outcome
Dysphagia severity
Time frame: Intervention group: 2-4 hours after TEE; Control group: At least two days before TEE
Change in presence and severity of dysphagia examined via FEES and scored by Rosenbek´s Penetration-Aspiration-Scale Minimum value: 1 Maximum value: 8 Higher scores mean worse outcome
Dysphagia severity
Time frame: Intervention group: 24 hours after TEE; Control group: At least one day before TEE
Change in presence and severity of dysphagia examined via FEES and scored by Rosenbek´s Penetration-Aspiration-Scale Minimum value: 1 Maximum value: 8 Higher scores mean worse outcome
Pharyngeal residue severity
Time frame: Intervention group: One day before TEE; Control group: At least three days before TEE
Change in presence and severity of dysphagia examined via FEES and scored by Yale Pharyngeal Residue Severity Rating Scale Minimum value: 1 Maximum value: 5 Higher scores mean worse outcome
Pharyngeal residue severity
Time frame: Intervention group: 2-4 hours after TEE; Control group: At least two days before TEE
Change in presence and severity of dysphagia examined via FEES and scored by Yale Pharyngeal Residue Severity Rating Scale Minimum value: 1 Maximum value: 5 Higher scores mean worse outcome
Pharyngeal residue severity
Time frame: Intervention group: 24 hours after TEE; Control group: At least one day before TEE
Change in presence and severity of dysphagia examined via FEES and scored by Yale Pharyngeal Residue Severity Rating Scale Minimum value: 1 Maximum value: 5 Higher scores mean worse outcome
2 secondary outcomes
Stroke severity
Time frame: At the day of admission to hospital and up to 2 weeks after TEE
Degree of disability after stroke
Time frame: At the day of admission to hospital and up to 2 weeks after TEE
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Background: PubMed 2564884Barer DH. The natural history and functional consequences of dysphagia after hemispheric stroke. J Neurol Neurosurg Psychiatry. 1989 Feb;52(2):236-41. doi: 10.1136/jnnp.52.2.236.
- Background: PubMed 7637370Hogue CW Jr, Lappas GD, Creswell LL, Ferguson TB Jr, Sample M, Pugh D, Balfe D, Cox JL, Lappas DG. Swallowing dysfunction after cardiac operations. Associated adverse outcomes and risk factors including intraoperative transesophageal echocardiography. J Thorac Cardiovasc Surg. 1995 Aug;110(2):517-22. doi: 10.1016/S0022-5223(95)70249-0.
- Derived from this study: PubMed 41146308Hamzic S, Juenemann M, Braun T, Piayda K, Bauer P, Sossalla S, Gerriets T, Khilan H, Butz M, Schramm P, Omar OA. TEDRAS II - transesophageal echocardiography as dysphagia risk in the acute phase of stroke-protocol for a prospective pilot observational trial. Trials. 2025 Oct 27;26(1):445. doi: 10.1186/s13063-025-09065-5.
- Individual participant dataSharing planned: No
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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.
Tibo Gerriets, MD principal investigator
Department of Neurology, University Hospital 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 Transesophageal Echocardiography (TEE) and Flexible Endoscopic Evaluation of Swallowing in people with Acute Stroke and Dysphagia, 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 5 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: finished, as of the sponsor's last update on 10 Mar 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Secretion severity (time frame: Intervention group: One day before TEE; Control group: At least three days before TEE). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04302883, which also lists 3 linked publications.
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 10 Mar 2020.