RecruitingOBSERVATIONAL

Dysphagia After Transesophageal Echocardiography in Acute Stroke - Follow Up Trial

This study, called the TEDRAS - Follow-up Trial, is looking into swallowing difficulties (dysphagia) after a type of heart scan called a transesophageal echocardiography (TEE) in people who have recently had a stroke. Having trouble swallowing is common after a stroke and can lead to serious issues like lung infections. A previous study, the TEDRAS-Trial, found that TEE might make swallowing problems worse in stroke patients. This new follow-up study aims to understand the reasons why this might happen and looks at things like the type of anaesthetic used during the TEE procedure. The goal is to improve care for stroke patients by understanding how different procedures might affect their recovery.

At a glance

Status

Recruiting

Sponsor

University of Giessen

Enrolment target

Start

01 May 2023

Estimated completion

31 Aug 2025

Ischemic Stroke, Acute Dysphagia Following Cerebrovascular Accident

What is this study about?

When someone has an acute stroke, it's quite common for them to experience difficulties with swallowing, a condition doctors call dysphagia. This can be serious because it increases the risk of food or drink going into the lungs, leading to infections like pneumonia, and can even increase the risk of dying. That's why it's really important for healthcare teams to spot swallowing problems early and help manage them.

After a stroke, doctors often perform a heart scan called a transesophageal echocardiography (TEE) to check if a heart problem caused the stroke. This scan involves a thin, flexible tube with a camera being gently guided down the throat. While very helpful, earlier research, including a study called the TEDRAS-Trial, suggested that having a TEE might sometimes make swallowing difficulties worse for stroke patients. This is similar to how TEE can sometimes cause swallowing problems after heart surgery.

This new study, the TEDRAS - Follow-up Trial, is being done to take a closer look at what was found in the first TEDRAS-Trial. Researchers want to understand more about why TEE might affect swallowing and look at specific details, like whether the type of pain relief or sedation (anaesthetic) given during the TEE scan makes a difference. By understanding these factors better, the aim is to find ways to make sure stroke patients get the best possible care during their recovery.

Key takeaways

Looks at swallowing problems (dysphagia) after stroke.
Investigates a potential link between heart scans (TEE) and worsening dysphagia.
Aims to improve stroke patient care by understanding effects of TEE.
This is an 'observational' study, meaning no new treatments are given.
Builds on previous research findings.

Who may be eligible?

To be considered for this study, you would need to have had a recent stroke that affects your brain (doctors call this an acute cerebral infarction, which they see on scans like an MRI or CT scan). You would also need to be a candidate for the TEE heart scan, meaning your doctors recommend you have one.

There are also some reasons why you wouldn't be able to join. For example, if your stroke caused bleeding in the brain (a cerebral hemorrhage), or if you couldn't safely have a special swallowing test called a FEES (Flexible Endoscopic Evaluation of Swallowing). This FEES test requires you to be alert enough to cooperate with the procedure.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have you recently had a stroke affecting your brain?
Has your doctor recommended you have a TEE heart scan?
Do you not have bleeding in your brain (cerebral hemorrhage)?
Are you able to be alert and cooperate for a swallowing test (FEES) if needed?

Answer every question to see your result.

What does participation involve?

If you join this study, it's called an "observational" study. This means the researchers will be carefully observing and collecting information about your usual medical care, rather than giving you new or experimental treatments. They will gather information related to your stroke, the TEE heart scan you receive as part of your standard care, and how your swallowing is assessed. This will likely involve careful tracking of your progress, particularly around the time of your TEE scan and your swallowing assessments. You will not be given any study drugs or have any extra procedures outside of what your doctors would normally recommend. The exact number of visits or the total length of your participation isn't specified, but it will follow your usual hospital stay and recovery.

Potential risks and benefits

Because this is an observational study, you wouldn't be taking any experimental medicines or having procedures that aren't already part of your standard care. The main benefit is that your participation could help doctors better understand how different procedures affect stroke recovery, potentially leading to improved care for future stroke patients. There are no additional risks beyond those associated with your routine medical care and the standard TEE and swallowing assessments. You are always free to decide to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

University Hospital Giessen and Marburg
Verified postcode
Giessen, Germany· Recruiting

Common questions

What is dysphagia?

Dysphagia is the medical term for difficulty swallowing, which can happen after a stroke.

What is a TEE scan?

A TEE (transesophageal echocardiography) is a heart scan where a small camera is passed down your throat to get a clear picture of your heart.

Why is this study important?

This study helps doctors understand if a TEE scan can affect swallowing problems after a stroke, which could improve patient care.

Does this study involve new treatments?

No, this is an observational study. You'll receive your usual medical care, and researchers will gather information about it.

Will my care change if I join?

No, joining this study will not change the medical care you receive from your doctors.

How to find out more

Samra Hamzic, Dr

samra.hamzic@neuro.med.uni-giessen.de +4917699807230 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.