NCT04302883

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: University of Giessen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Acute Stroke
• Dysphagia
• Swallowing Disorder

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Transesophageal Echocardiography (TEE)	Ultrasound of heart chambers via esophagus
DIAGNOSTIC_TEST	Flexible Endoscopic Evaluation of Swallowing	Endoscopical swallowing study

Timeline

• Start date: 2013-06-12
• Primary completion: 2019-09-05
• Completion: 2019-10-01
• First posted: 2020-03-10
• Last updated: 2020-03-10

Locations

1 site across 1 country: Germany