Aspiration Risk in Stroke Units. Validation of Clinical Investigation Procedures for Risk Stratification
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Penetration-Aspiration-Score (PAS) Penetration-Aspiration-Score (PAS)
研究概览
简要总结
The purpose of the study is to test the validity of a modified Daniels swallow test. The original test serves as reference method, the swallow endoscopy (FEES) as "gold standard".
Furthermore, it will be examined whether the modified Daniels test can be performed by nursing staff. As a reference method, the test will be performed by experienced speech therapists and the swallowing endoscopy (FEES) by speech therapists and/or physicians.
详细描述
For each included patient, the standardized Daniels test is performed by a speech therapist within the first 24 hours after admission, as well as the modified Daniels test by a second speech therapist who is blinded to the result of the first test. This is immediately followed by the administration of the modified Daniels test by a nurse. All investigators are blinded to the results of the preceding water swallow tests. The water swallow tests are not performed by physicians.
Following the water swallow tests, FEES is performed by an examiner (physician or speech therapist) experienced in FEES. The examination is digitally recorded and evaluated by an external examiner (physician or speech therapist) using validated scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
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 (maximum 7 days old) cerebral infarction detected by cMRI or cCT
- •Neurological deficits
- •Written informed consent
排除标准
- •Cerebral hemorrhage
- •Pre-existing swallowing disorders of other etiologies
- •Contraindications to clinical swallowing examination (lack of alertness as well as lack of compliance) - Contradictions to FEES (lack of alertness as well as lack of compliance)
研究组 & 干预措施
Clinical swallowing exam
Patients with acute ischemic stroke
干预措施: Flexible Endoscopic Evaluation of Swallowing (Diagnostic Test)
Clinical swallowing exam
Patients with acute ischemic stroke
干预措施: Daniels Water Swallow Test (Diagnostic Test)
结局指标
主要结局
Penetration-Aspiration-Score (PAS) 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
- Functional Oral Intake Scale-German (FOIS-G)(Immediately after the intervention)