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/32897605Actively Recruiting
Led by University of Giessen · Updated on 2024-06-06
40
Participants Needed
1
Research Sites
13 weeks
Total Duration
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
Dysphagia After Transesophageal Echocardiography in Acute Stroke - Follow Up Trial
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You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
Total: 1 location
1
University Hospital Giessen and Marburg
Giessen, Hesse, Germany, 35392
Actively Recruiting
S
Samra Hamzic, Dr
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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S Hamzic, T Braun, M Butz...
https://pubmed.ncbi.nlm.nih.gov/32897605Samra Hamzic, Martin Juenemann, Tobias Braun...
https://pubmed.ncbi.nlm.nih.gov/41146308