Transesophageal Echocardiography: Dysphagia Risk in Acute Stroke (T.E.D.R.A.S. Trial)
- Conditions
- Acute StrokeSwallowing DisorderDysphagia
- Interventions
- Diagnostic Test: Transesophageal Echocardiography (TEE)Diagnostic Test: Flexible Endoscopic Evaluation of Swallowing
- Registration Number
- NCT04302883
- Lead Sponsor
- University of Giessen
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
- 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
- brain hemorrhage
- either pre-existing neurogenic dysphagia or
- head-and-neck cancer induced dysphagia
- dementia
- aphasia with an impairment in language comprehension
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Transesophageal Echocardiography (TEE) TEE FEES Intervention group Flexible Endoscopic Evaluation of Swallowing TEE FEES Control group Transesophageal Echocardiography (TEE) FEES Control group Flexible Endoscopic Evaluation of Swallowing FEES
- Primary Outcome Measures
Name Time Method Dysphagia severity Intervention group: 24 hours after TEE; Control group: At least one day before TEE Change in presence and severity of dysphagia examined via FEES and scored by Rosenbek´s Penetration-Aspiration-Scale Minimum value: 1 Maximum value: 8 Higher scores mean worse outcome
Pharyngeal residue severity Intervention group: 24 hours after TEE; Control group: At least one day before TEE Change in presence and severity of dysphagia examined via FEES and scored by Yale Pharyngeal Residue Severity Rating Scale Minimum value: 1 Maximum value: 5 Higher scores mean worse outcome
Secretion severity Intervention group: 24 hours after TEE; Control group: At least one day before TEE Change in presence and severity of dysphagia examined via FEES and scored by Murray´s Secretions Severity Rating Scale Minimum value: 0 Maximum value: 3 Higher scores mean worse outcome
- Secondary Outcome Measures
Name Time Method Stroke severity At the day of admission to hospital and up to 2 weeks after TEE Quantification of stroke severity via National Institutes of Health Stroke Scale (NIHSS):
Minimum value: 0 Maximum value: 42 Higher scores mean worse outcomeDegree of disability after stroke At the day of admission to hospital and up to 2 weeks after TEE Measuring the degree of disability or dependance of stroke survivors as measured by the Modified Rankin Scale (MRS):
Minimum value: 0 Maximum value: 6 Higher scores mean worse outcome
Trial Locations
- Locations (1)
University Hospital Giessen and Marburg
🇩🇪Gießen, Hessen, Germany