Transoesophageal Echocardiography - Dysphagia Risk in Acute Stroke- TEDRAS 2 - Follow Up
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Yale Scale (YS)
研究概览
简要总结
The aim of the prospective observational TEDRAS - Follow-up Trial is to investigate the limitations of the initial TEDRAS - Trial in patients with acute Dysphagia is a common consequence from ischemic stroke and it correlates with an increased risk of pulmonary complications such as aspiration pneumonia and an increased mortality risk.
TEDRAS-Trial (Transesophageal Echocardiography: Dysphagia Risk in the Acute Phase After Stroke; ClinTrial.gov identifier NCT04302883) was the first randomized and controlled trial to address the question of the extent to which TEE increases dysphagia risk in acute stroke patients. The results of the study confirmed the hypothesis that dysphagia severity worsens after TEE in the intervention group.
The aim of the prospective observational TEDRAS - Follow-up Trial is to investigate the limitations of the initial TEDRAS - Trial in patients with acute ischemic stroke.
详细描述
Dysphagia is a common consequence from ischemic stroke and it correlates with an increased risk of pulmonary complications such as aspiration pneumonia and an increased mortality risk.
Early detection of dysphagia increases the overall outcome, reduces the mortality risk, the risk of aspiration pneumonia, malnutrition as well as the length of hospitalization and the overall costs of treatment.
In German stroke units within 24 hours of admission stroke patients undergo a clinical swallowing screening and the flexible endoscopic evaluation of swallowing (FEES), if necessary. FEES allows for a valid assessment of swallowing and description of dysphagia symptoms via standardized scores as the Secretion Severity Sating Scale (SSRS), the Penetration-Aspirations-Scale (PAS), the Yale Pharyngeal Residue Severity Scale (YSPRSS) and the Functional Oral Intake Scale (FOIS-G).
Transesophageal echocardiography (TEE) is conducted within the first few days after stroke as a routine examination to detect whether a cardiac disorder was the cause of stroke. The implementation of a TEE during cardiac surgery has a significant correlation with occurrences of postoperative dysphagia in patients after cardiac surgery [1].
TEDRAS-Trial (Transesophageal Echocardiography: Dysphagia Risk in the Acute Phase After Stroke; ClinTrial.gov identifier NCT04302883) [2] was the first randomized and controlled trial to address the question of the extent to which TEE increases dysphagia risk in acute stroke patients. The results of the study confirmed the hypothesis that dysphagia severity worsens after TEE in the intervention group [2].
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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 cerebral infarction detected by cMRI or cCT
- •Indication for TEE
- •Neurological deficits
- •Written informed consent
排除标准
- •Cerebral hemorrhage
- •Contraindications to FEES (lack of alertness as well as lack of compliance)
结局指标
主要结局
Yale Scale (YS)
时间窗: Immediately after the intervention
Yale Pharyngeal Residue Severity Rating Scale; minimum value 1, maximum value 5; higher scores mean worse outcome
Functional Oral Intake Scale-German (FOIS-G)
时间窗: Immediately after the intervention
Functional Oral Intake Scale - German Version; minimum value 1, maximum value 7; higher scores mean better outcome
Penetration-Aspiration-Score (PAS)
时间窗: Immediately after the intervention
Penetration-Aspiration-Score, minimum value 1, maximum value 8; higher scores mean worse outcome
次要结局
未报告次要终点
研究者
Samra Hamzic
Prinicipal Investigator
University of Giessen