Transesophageal Echocardiography: Dysphagia Risk in Acute Stroke (T.E.D.R.A.S. Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Dysphagia severity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •brain hemorrhage
- •either pre-existing neurogenic dysphagia or
- •head-and-neck cancer induced dysphagia
- •aphasia with an impairment in language comprehension
结局指标
主要结局
Dysphagia severity
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- Stroke severity(At the day of admission to hospital and up to 2 weeks after TEE)
- Degree of disability after stroke(At the day of admission to hospital and up to 2 weeks after TEE)