Feasibility of a Water-soluble Contrast Application Into Dysphagia Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 755
- 试验地点
- 1
- 主要终点
- Laryngeal protection
研究概览
简要总结
In traditional video-fluoroscopic-swallowing study, a lipid-soluble contrast (barium sulfate) has been used more than 30 years. However, it can cause chemical pneumonitis and subsequently impair reliability of video-fluoroscopic-swallowing study if aspirated. The authors reviewed the safety and usefulness of an water soluble agent-based swallowing test.
详细描述
Parallel-group, case-controlled trial was conducted from September 2015 to November 2017. All the patients who referred for video-fluoroscopic-swallowing study were screened.
Based on the pre-emptive evaluation, high-risky patients were allocated to iohexol (Omnipaque)-used video-fluoroscopic-swallowing study and others were allocated to barium sulfate-used video-fluoroscopic-swallowing study.
Statistical Package for the Social Sciences 24 was used to perform statistical analysis for the data. Quantitative data were presented as mean ± standard errors.
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
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All the patients who referred for video-fluoroscopic-swallowing study
排除标准
- 未提供
结局指标
主要结局
Laryngeal protection
时间窗: within 1 hour after video-fluoroscopic-swallowing study
Penetration aspiration scale (zero to eight)
次要结局
- Oral feeding(within 1 week before video-fluoroscopic-swallowing study)
研究者
Chang Ho Hwang
Associated Professor, PhD and MD
Ulsan University Hospital