Actively Recruiting

Age: 18Years +
All Genders
ID06195501

Transoesophageal Echocardiography - Dysphagia Risk in Acute Stroke TEDRAS 2 Follow Up

Led by University of Giessen · Updated on 2024-06-06

40

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Dysphagia, or difficulty swallowing, is a common problem after an ischemic stroke and is linked to higher risks of lung infections like aspiration pneumonia and increased chances of death. Early detection of dysphagia can improve outcomes and reduce complications, hospital stay length, and treatment costs. This trial follows up on an earlier study called TEDRAS, which first explored how a heart test called transesophageal echocardiography (TEE) affects swallowing problems in stroke patients. The goal is to better understand the limitations of that initial study in patients with acute ischemic stroke. Participants in this observational trial undergo swallowing assessments using a test called Flexible Endoscopic Evaluation of Swallowing (FEES) both one day before and within four hours after having TEE. TEE is done within the first few days after stroke to check if heart problems caused the stroke. During TEE, anesthesia is given either through an intravenous injection of propofol or a combination of propofol and local lidocaine spray. Patients are required to fast before and for several hours after the TEE procedure. Throughout the study, researchers will evaluate swallowing by using standardized scales such as the Penetration-Aspiration Score (PAS), the Functional Oral Intake Scale-German (FOIS-G), and the Yale Scale immediately after TEE. They will also study factors like the type of anesthesia, how long the TEE lasts, and typical swallowing symptoms after TEE. The study involves clinical swallowing screenings, neurological exams, and informed consent, with safety monitored by observing patient alertness and cooperation during tests.

CONDITIONS

Brief Title

Dysphagia After Transesophageal Echocardiography in Acute Stroke - Follow Up Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Acute cerebral infarction confirmed by brain MRI or CT scan
  • Indication for transesophageal echocardiography (TEE)
  • Presence of neurological deficits
  • Ability to provide written informed consent
Not Eligible

You will not qualify if you...

  • Presence of cerebral hemorrhage
  • Contraindications to Flexible Endoscopic Evaluation of Swallowing (FEES), such as lack of alertness or inability to comply with procedures

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Within 2 days around the TEE procedure

Participants undergo Flexible Endoscopic Evaluation of Swallowing (FEES) one day before and up to 4 hours after Transesophageal Echocardiography (TEE) to assess swallowing ability and dysphagia symptoms.

2 visits (in-person)

Long-term Monitoring

Duration - Up to several weeks post-TEE depending on clinical follow-up

Participants are observed for swallowing function and dysphagia symptoms following the TEE and FEES assessments to investigate the influence of anesthesia type and TEE duration on swallowing.

Visit schedule varies depending on clinical follow-up

Trial Site Locations

Total: 1 location

1

University Hospital Giessen and Marburg

Giessen, Hesse, Germany, 35392

Actively Recruiting

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Research Team

S

Samra Hamzic, Dr

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Transesophageal Echocardiography - Dysphagia Risk in Acute Stroke (TEDRAS): a prospective, blind, randomized and controlled clinical trial.

S Hamzic, T Braun, M Butz...

https://pubmed.ncbi.nlm.nih.gov/32897605

TEDRAS II - transesophageal echocardiography as dysphagia risk in the acute phase of stroke-protocol for a prospective pilot observational trial.

Samra Hamzic, Martin Juenemann, Tobias Braun...

https://pubmed.ncbi.nlm.nih.gov/41146308