Acute Stroke, Dysphagia, Swallowing Disorder
Conditions
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.
Interventions
DIAGNOSTIC_TESTTransesophageal Echocardiography (TEE)
Ultrasound of heart chambers via esophagus
DIAGNOSTIC_TESTFlexible Endoscopic Evaluation of Swallowing
Endoscopical swallowing study
Sponsors
University of Giessen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Secretion severity | Intervention group: One day before TEE; Control group: At least three days 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 |
| Dysphagia severity | Intervention group: One day before TEE; Control group: At least three days 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: One day before TEE; Control group: At least three days 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 outcome |
| Degree 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 |
Countries
Germany
Outcome results
None listed