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临床试验/NCT04621734
NCT04621734已完成不适用

Improving Retention of Nasoenteric Feeding Tubes in Pediatric Patients Using a Nasal Bridle

The University of Texas Health Science Center at San Antonio2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2020年2月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
2
主要终点
Number of Tube Dislodgements Per 10 Tube Days.

研究概览

简要总结

A study to compare tube dislodgment rates when a nasoenteric feeding tube is secured with adhesive tape vs the AMT BridlePro device.

详细描述

The adhesive tape will be the tape available in the unit and will be placed by the nurse or provider at the time of nasoenteric tube placement. The tape will be placed around the tube and secured to the cheek on the side of tube. The tape will be replaced as needed per nursing discretion when soiled or the adhesive properties are failing and this information will be tracked. The AMT BridlePro will be placed by the nurse or provider at the time of nasoenteric tube placement. Placement will use the BridlePro system included in the individual BridlePro packaging. Placement and securement will follow manufacturer recommendations and teaching. The BridlePro encircles the vomer bone of the nasal cavity to secure the tube. Sedation medication may be given per standard of care for nasoenteric tube placement at the discretion of the provider team but no separate or additional sedation medication will be given for securement with adhesive tape or the BridlePro.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Need for nasoenteric feeding
  • Admitted to University Hospital
  • Age 0-18 years

排除标准

  • Facial trauma
  • Nasal airway obstructions
  • Thrombocytopenia (<100 K/μL)
  • s/p septoplasty
  • Patients with vomer bone graft
  • Nasoenteric feeding tube placed and secured prior to being screened for study
  • Contraindication for the use of the BridlePro
  • Does not meet inclusion criteria

结局指标

主要结局

Number of Tube Dislodgements Per 10 Tube Days.

时间窗: 10 days

The number of times the tube is dislodged for every 10 days of feeding tubes.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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