Nasal Bridle Versus Nasal Patch for Fixation of Nasoenteral Feeding Tubes: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Premature dislocation of feeding tube
研究概览
简要总结
Aim of this study is to compare fixation of nasoenteral feeding tubes using either a nasal patch or a nasal bridle in clinical patients with regard to the occurrence of tube dislocation, complications, and discomfort. 78 (2 * 39) eligible patients will be included in this randomized controlled trial. The study is executed in two general teaching hospitals in the Netherlands (Gelre Hospitals Apeldoorn and Medical Spectrum Twente).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
盲法说明
The data analist who will perform the statistical analyses (TS) will be masked (i.e., will analyze groups labelled as 'A' and 'B').
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
- •adult patient (18 years or older)
- •received a nasoenteral feeding tube while being hospitalized
- •providing written informed consent
排除标准
- •contraindication for a nasal bridle (e.g., cleft lip or damaged nasal mucosa)
- •clinical need to place a nasal bridle
- •anticipated feeding nasoenteral feeding tube placement for < 3 days
- •failure of nasoenteral feeding tube placement
结局指标
主要结局
Premature dislocation of feeding tube
时间窗: Within 14 days after initial placement of the feeding tube
Occurrence of a first premature dislocation of the feeding tube
次要结局
- Pain experienced from the nasal fixation(During the 14-day period after initial placement of the feeding tube)
- Discomfort experienced from the nasal fixation(During the 14-day period after initial placement of the feeding tube)
- Complications related to fixation of the feeding tube(During the 14-day period after initial placement of the feeding tube)
