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临床试验/NCT05694299
NCT05694299招募中不适用

Nasal Bridle Versus Nasal Patch for Fixation of Nasoenteral Feeding Tubes: a Randomized Controlled Clinical Trial

Gelre Hospitals2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2021年11月1日最近更新:
适应症

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

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)

研究者

发起方
Gelre Hospitals
申办方类型
Other
责任方
Sponsor

研究点 (2)

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