Valuation of Airway Protection (Swalling) in Patient Sedated for Gastroenteric Endoscopic Procedure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Swallowing impairment
研究概览
简要总结
Aim of this study is to evaluate swallowing functionality in patient sedated for gastroenteric endoscopic procedure.
Swallowing will be study by laryngeal fibroscopy and evaluate using Penetration-Aspiration Scale and Aspiration Risk validated in scientific literature.
Aim of the study is to describe swallowing, as an expression of airway protection, in sedated patient. in particular, our purpose is to determine the incidence of moderate-severe and severe swallowing alteration (level 3 or 4 of Aspiration Risk scale).
详细描述
All patients will be sedated using propofol target controlled infusion (TCI) with a target of 2-5 mcg/ml During sedation and examination will be monitored: cardiac frequency, peripheral oxygen saturation and non-invasive arterial blood pressure.
During sedation, before starting the gastroenteric endoscopic exam, will be performed a fibroscopic swallowing evaluation made by an expert otolaryngologist.
Fibroscopic evaluation consist of:
- laryngeal fibroscopy to evaluate vocal cord motility
- swallowing trial using 3 blue colored water bolus (3-4ml) and computing a " Penetration-aspiration scale" and an " Aspiration risk scale"
Rosenbek, Robbins et al. A Penetration-Aspiration Scale. Dysphagia 11:93-98, 1996:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status I-II-III
- •Able to give written consent with none exclusion criteria.
排除标准
- •presence of feeding tube
- •presence of tracheostomy actual or in the past
- •severe respiratory deficit
- •neurological disease which can compromise swallowing function
- •history of surgery for mouth or pharyngeal or esophageal cancer
- •history of otolaryngology surgery
- •faring-laryngeal radiotherapy
- •emergent procedure
- •psychic alteration
- •patient in therapy with any kind of antidepressant drugs
- •insulin dependent diabetes mellitus patient
结局指标
主要结局
Swallowing impairment
时间窗: 12 months
Primary outcomes of this study is to verify if there is any kind of swallowing impairment during sedation with propofol and to quantify the eventual impairment. Swallowing function will be study by fibroscopic evaluation, that consists of: * laryngeal fibroscopy to evaluate vocal cord motility * swallowing trial using 3 blue colored water bolus (3-4ml) and computing a " Penetration-aspiration scale" and an " Aspiration risk scale" (see above)
次要结局
- Inhalation(12 months)
研究者
Agostoni Massimo
Medical Doctor
Ospedale San Raffaele