The Pathophysiology of Post-extubation Dysphagia in ICU Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- The number of patients with aspiration during FEES will be assessed.
研究概览
简要总结
Mechanical ventilation is a widely used treatment on the Intensive Care Unit (ICU). Swallowing dysfunction (dysphagia) after extubation may cause aspiration, and is associated with poor outcomes: pneumonia, reintubation, a prolonged length of hospital stay and increased mortality. The exact underlying pathophysiology of post-extubation dysphagia (PED) is unknown. This exploratory pilot study is the first step that aims to fill this knowledge gap to ultimately improve current treatment and prevention of post-extubation dysphagia.
Using FEES (Flexible Endoscopic Evaluation of Swallowing), HRIM (High Resolution Impedance Manometry) and EMG (electromyography) simultaneously, 5 healthy subjects and 25 patients within 24 hours after extubation will be studied.
详细描述
Observational study model:
The group of healthy subjects will be recruited using posters at the local university and the internet. The healthy subjects will be studied before the group of patients to assess the feasibility and possible interactions of simultaneously recording FEES, HRIM and EMG. Then, the group of patients will be studied. They will be recruited from the Intensive Care Unit. See In- and Exclusion criteria for details.
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
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
The number of patients with aspiration during FEES will be assessed.
时间窗: At time of measurement (within 24 hours post-extubation)
次要结局
- Interaction of FEES on HRIM recording(At time of measurement (within 24 hours post-extubation))
- Correlation of FEES with HRIM(At time of measurement (within 24 hours post-extubation))
- The number of adverse events will be assessed.(Participants will be followed until hospital discharge, an expected average of 28 days)
- Pathophysiology of PED(At time of measurement (within 24 hours post-extubation))