Influence of Swallow Gel and Semi-solid Consistency on Medication Dysphagia: A Multicenter Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- Medication dysphagia score according to Labeit et al 2022; DOI: 10.1038/s41531-022-00421-9
研究概览
简要总结
This research project examines the prevalence of medication-related dysphagia in patients with dysphagia-associated diseases. Its primary aim is to assess how frequently swallowing difficulties occur during medication intake and to evaluate the impact of different consistencies-such as semi-solid formulations and commercial swallowing gels-on the swallowing process. Flexible endoscopic evaluation of swallowing serves as the diagnostic gold standard to determine whether alternative administration forms can facilitate safer swallowing. The findings are intended to support the optimization of medication intake and the prevention of complications in patients with dysphagia.
详细描述
Dysphagia refers to an impairment of the swallowing process, encompassing the transport of the food bolus from the oral cavity to the gastrointestinal tract. In neurological patients, combined disturbances of the oral and pharyngeal phases frequently occur, known as oropharyngeal dysphagia. This form of dysphagia not only significantly reduces quality of life but may also lead to severe complications.
A particularly relevant aspect of dysphagia is impaired swallowing of medication, referred to as medication dysphagia. This may compromise swallowing efficiency, for example when tablets or capsules remain in the oral cavity or pharynx and dissolve prematurely. Swallowing safety can also be affected, especially in cases of penetration or aspiration during medication intake.
To compensate for these difficulties, patients are often advised to swallow medication together with semi-solid substances instead of liquids. In addition, a commercially available swallowing gel has recently become accessible, designed specifically to facilitate medication intake in patients with dysphagia.
Despite its clinical relevance, medication dysphagia has rarely been investigated systematically with instrumental diagnostics. In particular, the compensatory strategies widely applied in practice have not yet been scientifically evaluated.
Objectives
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
- •Adults with a dysphagia-associated disease (neurovascular, neurodegenerative, neuroinflammatory, or neuromuscular disorders; in other centers also ENT-related diseases), for whom FEES is clinically indicated.
- •Capable of providing informed consent and cognitively able to follow the study protocol.
- •Healthy Controls Adults without any dysphagia-associated disease (no neurovascular, neurodegenerative, neuroinflammatory, or neuromuscular disorders; no ENT-related diseases with structural abnormalities of the oropharynx or esophagus).
- •Capable of providing informed consent and cognitively able to follow the study protocol.
排除标准
- •No additional exclusion criteria beyond those specified in the inclusion criteria.
结局指标
主要结局
Medication dysphagia score according to Labeit et al 2022; DOI: 10.1038/s41531-022-00421-9
时间窗: on the day of enrollment. This is not a longitudinal study but a one-time examination; all assessments take place on the day of enrollment.
Medication dysphagia swallowing score according to FEES (Labeit et al 2022; doi: 10.1038/s41531-022-00421-9)
时间窗: on the day of enrollment. This is not a longitudinal study but a one-time examination; all assessments take place on the day of enrollment.
as published here: Labeit et al 2022; doi: 10.1038/s41531-022-00421-9
次要结局
未报告次要终点