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

backgroundDysphagia is as a common consequence of cerebral infarction affecting approximately 50% of stroke patients. It often results in aspiration pneumonia, malnutrition and dehydration. Dysphagia is also seen after mechanical manipulation of the larynx, for example after prolonged intubation and after the perioperative use of transesophageal echocardiography (TEE). TEE is a semi-invasive procedure assessing the function of the intra-atrial septum and heart valves, yielding more detailed results compared to transthoracic echocardiography (1). It has become a routine in the diagnostic work-up of stroke. The study Transoesophageal echocardiography: dysphagia risk in the acute phase after stroke (TEDRAS study) was the first to investigate the extent of dysphagia risk after TEE in acute stroke patients. The trial findings supported the hypothesis that dysphagia severity worsens following TEE. This follow-up trial is designed to address the limitations of the first TEDRAS study, focusing on patients with ischaemic stroke and transient ischemic attack (TIA).

methodsThe study is a prospective, single-blinded, controlled pilot trial, designed in accordance with the SPIRIT reporting guidelines. The study protocol outlines that both FEES and TEE will be performed on patients with acute ischaemic stroke or transient ischemic attack (TIA) who provide informed consent to participate. Specifically, the following parameters are to be analyzed in both groups: (1) The impact of the type and method of anaesthesia administration (intravenous vs. local anesthetic spray application) during TEE on swallowing function in both cohorts; (2) The effect of the duration of the TEE procedure on swallowing function in both cohorts; (3) The experience level of the TEE examiner; (4) The interrater reliability of the FEES assessment. The trial will be conducted at the University Medical Centre of the Justus-Liebig-University in Giessen (UKGM) through collaboration between the Departments of Neurology and Cardiology of the UKGM. DISCUSSION: This protocol presents a prospective pilot single-blinded controlled study designed to assess further risks of dysphagia following TEE. The trial aims to address several outcomes, specifically the impact of anaesthesia and the duration of TEE on swallowing, which will be correlated with the severity of dysphagia after TEE.

trial registrationClinTrial.gov Identifier NCT04302883. URL: https://clinicaltrials.gov/study/NCT06195501?term=TEDRAS&rank=1 Registered June 2024.