Ischemic Stroke, AcuteTEDRAS2NCT06195501
Dysphagia After Transesophageal Echocardiography in Acute Stroke - Follow Up Trial
An observational study of Ischemic Stroke, Acute and Dysphagia Following Cerebrovascular Accident, run by University of Giessen at 1 site in Germany.
Trial summary
The aim of the prospective observational TEDRAS - Follow-up Trial is to investigate the limitations of the initial TEDRAS - Trial in patients with acute Dysphagia is a common consequence from ischemic stroke and it correlates with an increased risk of pulmonary complications such as aspiration pneumonia and an… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Acute, Dysphagia Following Cerebrovascular Accident
- What is being tested?
- Flexible Endoscopic Evaluation of Swallowing (FEES) ; Transesophageal Ecocardiography (TEE)
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2023to 31 Aug 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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
Study population: Patients with acute ischemic stroke and indication for TEE
Who may be able to join
- Acute cerebral infarction detected by cMRI or cCT
- Indication for TEE
- Neurological deficits
- Written informed consent
Who cannot join
- Cerebral hemorrhage
- Contraindications to FEES (lack of alertness as well as lack of compliance)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Giessen and Marburg
Giessen, Hesse, 35392
Samra Hamzic, M.A., +49 17699807230, samra.hamzic@neuro.med.uni-giessen.de
Samra Hamzic, M.A.
About this study
Official title: Transoesophageal Echocardiography - Dysphagia Risk in Acute Stroke- TEDRAS 2 - Follow Up
The aim of the prospective observational TEDRAS - Follow-up Trial is to investigate the limitations of the initial TEDRAS - Trial in patients with acute Dysphagia is a common consequence from ischemic stroke and it correlates with an increased risk of pulmonary complications such as aspiration pneumonia and an increased mortality risk.
TEDRAS-Trial (Transesophageal Echocardiography: Dysphagia Risk in the Acute Phase After Stroke; ClinTrial.gov identifier NCT04302883) was the first randomized and controlled trial to address the question of the extent to which TEE increases dysphagia risk in acute stroke patients. The results of the study confirmed the hypothesis that dysphagia severity worsens after TEE in the intervention group.
The aim of the prospective observational TEDRAS - Follow-up Trial is to investigate the limitations of the initial TEDRAS - Trial in patients with acute ischemic stroke.
Read the detailed description
Dysphagia is a common consequence from ischemic stroke and it correlates with an increased risk of pulmonary complications such as aspiration pneumonia and an increased mortality risk.
Early detection of dysphagia increases the overall outcome, reduces the mortality risk, the risk of aspiration pneumonia, malnutrition as well as the length of hospitalization and the overall costs of treatment.
In German stroke units within 24 hours of admission stroke patients undergo a clinical swallowing screening and the flexible endoscopic evaluation of swallowing (FEES), if necessary. FEES allows for a valid assessment of swallowing and description of dysphagia symptoms via standardized scores as the Secretion Severity Sating Scale (SSRS), the Penetration-Aspirations-Scale (PAS), the Yale Pharyngeal Residue Severity Scale (YSPRSS) and the Functional Oral Intake Scale (FOIS-G).
Transesophageal echocardiography (TEE) is conducted within the first few days after stroke as a routine examination to detect whether a cardiac disorder was the cause of stroke. The implementation of a TEE during cardiac surgery has a significant correlation with occurrences of postoperative dysphagia in patients after cardiac surgery [1].
TEDRAS-Trial (Transesophageal Echocardiography: Dysphagia Risk in the Acute Phase After Stroke; ClinTrial.gov identifier NCT04302883) [2] was the first randomized and controlled trial to address the question of the extent to which TEE increases dysphagia risk in acute stroke patients. The results of the study confirmed the hypothesis that dysphagia severity worsens after TEE in the intervention group [2].
The aim of the prospective observational TEDRAS - Follow-up Trial is to investigate the limitations of the initial TEDRAS - Trial in patients with acute ischemic stroke.
In particular, the following parameters will be examined:
- The influence of the type and route (intravenous vs. oral) of anesthesia administered during TEE on swallowing in all cohorts studied.
- The correlation between the duration of TEE and the degree of deterioration in FOIS-G after TEE.
- The interrater reliability for the FEES.
- Definition of typical dysphagia symptoms after TEE.
- Being tested
- Flexible Endoscopic Evaluation of Swallowing (FEES) ; Transesophageal Ecocardiography (TEE)
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible Endoscopic Evaluation of Swallowing (FEES) ; Transesophageal Ecocardiography (TEE)Diagnostic test
Flexible Endoscopic Evaluation of Swallowing (FEES):
FEES is performed for analysis of swallowing ability according to the same methodology as in the initial trial: one day before a TEE and max. 4 hours after TEE. Before the FEES anticongestive nose drops are applied and the nostrils are anaesthetized by applying a lidocaine gel via cotton sticks. During the FEES examination the participants sit upright and are asked to swallow various consistencies: FEES is aborted in case of aspiration of any of the consistencies during the examination.
Transesophageal Ecocardiography (TEE):
For the TEE anesthesia is applied via intravenous injection of propofol or a combined anesthesia, through intravenous application of propofol and local anesthesia, using lidocaine spray. All patients undergoing a TEE are sober before and at least two to four hours after TEE.
| Study group | Role | What they receive |
|---|---|---|
| Acute ischemic stroke | Patients with acute ischemic stroke and an indication for a transesophageal ecocardiography Receives: Diagnostic Test: Flexible Endoscopic Evaluation of Swallowing (FEES) ; Transesophageal Ecocardiography (TEE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penetration-Aspiration-Score (PAS)
Penetration-Aspiration-Score, minimum value 1, maximum value 8; higher scores mean worse outcome
Measured: Immediately after the intervention
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
Yale Scale (YS)
Yale Pharyngeal Residue Severity Rating Scale; minimum value 1, maximum value 5; higher scores mean worse 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 Jan 2024
- Study start1 May 2023
- Primary completion30 May 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samra Hamzic, University of Giessen
- Investigators
- Samra Hamzic, Dr, Principal investigator, University Hospital Giessen and Marburg, Campus Giessen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06195501
- Sponsor's protocol ID
- TEDRAS2
- Acronym
- TEDRAS2
- Status last verified
- Jun 2024
- First submitted
- 22 Dec 2023
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hamzic S, Braun T, Butz M, Khilan H, Weber S, Yeniguen M, Gerriets T, Schramm P, Juenemann M. Transesophageal Echocardiography - Dysphagia Risk in Acute Stroke (TEDRAS): a prospective, blind, randomized and controlled clinical trial. Eur J Neurol. 2021 Jan;28(1):172-181. doi: 10.1111/ene.14516. Epub 2020 Oct 10.
PubMed 32897605Hamzic 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 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transoesophageal Echocardiography - Dysphagia Risk in Acute Stroke- TEDRAS 2 - Follow Up
- ClinicalTrials.gov ID
- NCT06195501
- Acronym / sponsor ID
- TEDRAS2 / TEDRAS2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 8 Jan 2024 (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 aim of the prospective observational TEDRAS - Follow-up Trial is to investigate the limitations of the initial TEDRAS - Trial in patients with acute Dysphagia is a common consequence from ischemic stroke and it correlates with an increased risk of pulmonary complications such as aspiration pneumonia and an increased mortality risk.
TEDRAS-Trial (Transesophageal Echocardiography: Dysphagia Risk in the Acute Phase After Stroke; ClinTrial.gov identifier NCT04302883) was the first randomized and controlled trial to address the question of the extent to which TEE increases dysphagia risk in acute stroke patients. The results of the study confirmed the hypothesis that dysphagia severity worsens after TEE in the intervention group.
The aim of the prospective observational TEDRAS - Follow-up Trial is to investigate the limitations of the initial TEDRAS - Trial in patients with acute ischemic stroke.
Detailed description
Dysphagia is a common consequence from ischemic stroke and it correlates with an increased risk of pulmonary complications such as aspiration pneumonia and an increased mortality risk.
Early detection of dysphagia increases the overall outcome, reduces the mortality risk, the risk of aspiration pneumonia, malnutrition as well as the length of hospitalization and the overall costs of treatment.
In German stroke units within 24 hours of admission stroke patients undergo a clinical swallowing screening and the flexible endoscopic evaluation of swallowing (FEES), if necessary. FEES allows for a valid assessment of swallowing and description of dysphagia symptoms via standardized scores as the Secretion Severity Sating Scale (SSRS), the Penetration-Aspirations-Scale (PAS), the Yale Pharyngeal Residue Severity Scale (YSPRSS) and the Functional Oral Intake Scale (FOIS-G).
Transesophageal echocardiography (TEE) is conducted within the first few days after stroke as a routine examination to detect whether a cardiac disorder was the cause of stroke. The implementation of a TEE during cardiac surgery has a significant correlation with occurrences of postoperative dysphagia in patients after cardiac surgery [1].
TEDRAS-Trial (Transesophageal Echocardiography: Dysphagia Risk in the Acute Phase After Stroke; ClinTrial.gov identifier NCT04302883) [2] was the first randomized and controlled trial to address the question of the extent to which TEE increases dysphagia risk in acute stroke patients. The results of the study confirmed the hypothesis that dysphagia severity worsens after TEE in the intervention group [2].
The aim of the prospective observational TEDRAS - Follow-up Trial is to investigate the limitations of the initial TEDRAS - Trial in patients with acute ischemic stroke.
In particular, the following parameters will be examined:
- The influence of the type and route (intravenous vs. oral) of anesthesia administered during TEE on swallowing in all cohorts studied.
- The correlation between the duration of TEE and the degree of deterioration in FOIS-G after TEE.
- The interrater reliability for the FEES.
- Definition of typical dysphagia symptoms after TEE.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute ischemic stroke | – | Diagnostic Test: Flexible Endoscopic Evaluation of Swallowing (FEES) ; Transesophageal Ecocardiography (TEE)Patients with acute ischemic stroke and an indication for a transesophageal ecocardiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute ischemic stroke and indication for TEE
Key inclusion criteria (4 listed)
- Acute cerebral infarction detected by cMRI or cCT
- Indication for TEE
- Neurological deficits
- Written informed consent
Key exclusion criteria (2 listed)
- Cerebral hemorrhage
- Contraindications 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 |
|---|---|---|
| Flexible Endoscopic Evaluation of Swallowing (FEES) ; Transesophageal Ecocardiography (TEE)Flexible Endoscopic Evaluation of Swallowing (FEES): FEES is performed for analysis of swallowing ability according to the same methodology as in the initial trial: one day before a TEE and max. 4 hours after TEE. Before the FEES anticongestive nose drops are applied and the nostrils are anaesthetized by applying a lidocaine gel via cotton sticks. During the FEES examination the participants sit upright and are asked to swallow various consistencies: FEES is aborted in case of aspiration of any of the consistencies during the examination. Transesophageal Ecocardiography (TEE): For the TEE anesthesia is applied via intravenous injection of propofol or a combined anesthesia, through intravenous application of propofol and local anesthesia, using lidocaine spray. All patients undergoing a TEE are sober before and at least two to four hours after TEE. | Diagnostic test | Acute ischemic stroke |
Primary outcome
Penetration-Aspiration-Score (PAS)
Time frame: Immediately after the intervention
Penetration-Aspiration-Score, minimum value 1, maximum value 8; higher scores mean worse outcome
Functional Oral Intake Scale-German (FOIS-G)
Time frame: Immediately after the intervention
Functional Oral Intake Scale - German Version; minimum value 1, maximum value 7; higher scores mean better outcome
Yale Scale (YS)
Time frame: Immediately after the intervention
Yale Pharyngeal Residue Severity Rating Scale; minimum value 1, maximum value 5; higher scores mean worse outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Results publication: PubMed 32897605Hamzic S, Braun T, Butz M, Khilan H, Weber S, Yeniguen M, Gerriets T, Schramm P, Juenemann M. Transesophageal Echocardiography - Dysphagia Risk in Acute Stroke (TEDRAS): a prospective, blind, randomized and controlled clinical trial. Eur J Neurol. 2021 Jan;28(1):172-181. doi: 10.1111/ene.14516. Epub 2020 Oct 10.
- 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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, Dr principal investigator
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?
An observational study of Ischemic Stroke, Acute and Dysphagia Following Cerebrovascular Accident, 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samra Hamzic, Dr (+4917699807230, samra.hamzic@neuro.med.uni-giessen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penetration-Aspiration-Score (PAS) (time frame: Immediately after the intervention). The study lists 3 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 NCT06195501, which also lists 2 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 6 Jun 2024.