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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acute Stroke, Dysphagia, Swallowing Disorder

Intervention / Treatment
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* Diagnostic Test: Transesophageal Echocardiography (TEE)
* Diagnostic Test: Flexible Endoscopic Evaluation of Swallowing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>TEE FEES | Diagnostic Test: Transesophageal Echocardiography (TEE)<br>* Ultrasound of heart chambers via esophagus<br>Diagnostic Test: Flexible Endoscopic Evaluation of Swallowing<br>* Endoscopical swallowing study<br>|
| Active Comparator: Control group<br>FEES | Diagnostic Test: Transesophageal Echocardiography (TEE)<br>* Ultrasound of heart chambers via esophagus<br>Diagnostic Test: Flexible Endoscopic Evaluation of Swallowing<br>* Endoscopical swallowing study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secretion severity | 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 | Intervention group: One day before TEE; Control group: At least three days before TEE | 
| Secretion severity | 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 | Intervention group: 2-4 hours after TEE; Control group: At least two days before TEE | 
| Secretion severity | 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 | Intervention group: 24 hours after TEE; Control group: At least one day before TEE | 
| Dysphagia severity | 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 | Intervention group: One day before TEE; Control group: At least three days before TEE | 
| Dysphagia severity | 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 | Intervention group: 2-4 hours after TEE; Control group: At least two days before TEE | 
| Dysphagia severity | 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 | Intervention group: 24 hours after TEE; Control group: At least one day before TEE | 
| Pharyngeal residue severity | 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 | Intervention group: One day before TEE; Control group: At least three days before TEE | 
| Pharyngeal residue severity | 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 | Intervention group: 2-4 hours after TEE; Control group: At least two days before TEE | 
| Pharyngeal residue severity | 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 | Intervention group: 24 hours after TEE; Control group: At least one day before TEE | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke severity | Quantification of stroke severity via National Institutes of Health Stroke Scale (NIHSS): Minimum value: 0 Maximum value: 42 Higher scores mean worse outcome | At the day of admission to hospital and up to 2 weeks after TEE | 
| Degree of disability after stroke | 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 | At the day of admission to hospital and up to 2 weeks after TEE |