Transesophageal Echocardiography: Dysphagia Risk in Acute Stroke (T.E.D.R.A.S. Trial) (TEDRAS)

University of Giessen

Status: Completed

Conditions: Dysphagia; Swallowing Disorder; Acute Stroke

Treatments: Diagnostic Test: Transesophageal Echocardiography (TEE); Diagnostic Test: Flexible Endoscopic Evaluation of Swallowing

Study type: Interventional

Funder types: Other

Identifiers

NCT04302883

TEDRAS-1

Details and patient eligibility

About

The prevalence of dysphagia in acute stroke patients undergoing transesophageal echocardiography (TEE) is unknown. The aim of this study was to assess for the first time whether TEE has a negative influence on swallowing in acute stroke patients.

Full description

Dysphagia is common in patients with acute stroke and deteriorates the overall outcome (1). Transesophageal echocardiography (TEE) is a routine examination in the diagnostic workup of stroke etiology. In cardiac surgery it is known as cause of postoperative dysphagia (2).

Using flexible endoscopic evaluation of swallowing (FEES) T.E.D.R.A.S., as a prospective, blinded, randomized and controlled study, includes patients in two groups in order to test the influence of TEE on swallowing in acute stroke: an intervention group and a control group. FEES is performed for analysis of swallowing in the intervention group (1) one day before TEE, (2) 2-4 hours after TEE, (3) 24 hours after TEE. In the control group FEES is performed on three consecutive days with TEE taking place any time after the last FEES. Validated scores assess dysphagia severity in both groups.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• acute stroke (max. 7 days post-onset) as displayed by a cranial computed tomography (CT) or magnetic resonance imaging (MRI)
• written informed consent either by patients themselves or by a legal representative
• indication for TEE

Exclusion criteria

• brain hemorrhage
• either pre-existing neurogenic dysphagia or
• head-and-neck cancer induced dysphagia
• dementia
• aphasia with an impairment in language comprehension

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups

Intervention group

Experimental group

Description:

TEE FEES

Treatment:

Diagnostic Test: Flexible Endoscopic Evaluation of Swallowing

Diagnostic Test: Transesophageal Echocardiography (TEE)

Control group

Active Comparator group

Description:

FEES

Treatment:

Diagnostic Test: Flexible Endoscopic Evaluation of Swallowing

Diagnostic Test: Transesophageal Echocardiography (TEE)