Findings and Side-effects of Flexible Endoscopic Evaluation of Swallowing - the FEES-Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,401
- 试验地点
- 1
- 主要终点
- FEES-related side effects - 6. Decreased level of consciousness
研究概览
简要总结
Neurogenic dysphagia is one of the most frequent and prognostically relevant neurological deficits in a variety of disorders, such as stroke, parkinsonism and advanced neuromuscular diseases. Flexible endoscopic evaluation of swallowing (FEES) is now probably the most frequently used tool for objective dysphagia assessment in Germany. It allows evaluation of the efficacy and safety of swallowing, determination of appropriate feeding strategies and assessment of the efficacy of different swallowing manoeuvres. The literature furthermore indicates that FEES is a safe and well-tolerated procedure. The FEES-Registry aims at evaluating findings and side effects of FEES in a heterogeneous collective of patients with neurogenic dysphagia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
FEES-related side effects - 6. Decreased level of consciousness
时间窗: during the procedure
Number of patients with a decline in consciousness during the procedure (measured with the Richmond agitation and sedation scale)
FEES-related side effects - 2. Oxygen saturation decline
时间窗: during the procedure
Oxygen saturation will be measured directly prior, during and directly after the procedure. The initial value will be compared to the lowest value measured during/directly after the procedure.
FEES-related side effects - 1. systolic blood pressure increase
时间窗: during the procedure
Systolic blood pressure will be measured directly prior, during and after the procedure. The initial value will be compared to the highest blood pressure value measured during/directly after the procedure.
FEES-related side effects - 3. Heart rate decrease
时间窗: during the procedure
Heart rate will be measured directly prior, during and directly after the procedure. The initial value will be compared to the lowest value measured during/directly after the procedure.
FEES-related side effects - 5. Laryngospasm
时间窗: during the procedure
Number of patients with laryngospasm during the procedure
FEES-related side effects - 4. Nose bleed
时间窗: during the procedure
Number of patients with nose bleed during the procedure
Patients subjective FEES-related discomfort
时间窗: during the procedure
Number of patients with procedure related discomfort measured with a 4 point scale ranging from 1=no discomfort to 4=extremely painful sensation during the procedure
次要结局
- Changes of dietary status after FEES(immediately prior and immediately after the procedure)