A Randomized Controlled Trial for Optimal Feeding Tube Placement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Duration of Time
研究概览
简要总结
A randomized controlled trial comparing current standard blind method to CORTRAK enteral access system (CEAS), an FDA approved electromagnetic device to place enteric tubes.
详细描述
Patient population would include patients in pediatric intensive care unit, pediatric cardiac unit, intermediate medical care unit and pediatric floor who receives postpyloric feeding tube placements. The study team are going to monitor total time and number attempts required for each successful placement, correlation of findings on x-ray versus CEAS, cost-effectiveness of this new equipment with standard blind method and decrease in radiation exposure with CEAS.
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
- 否
入选标准
- •Patient admitted to pediatric floor, intermediate care unit, pediatric intensive care unit, or congenital care unit requiring post-pyloric feeding tube placement of size eight french or more and not meeting any of
排除标准
- •Exclusion Criteria: Under three kilograms, Open chest wall, Open abdominal wall
研究组 & 干预措施
Standard Blind Technique of Tube placement
FDA approved technique of enteral nutrition tube placement
干预措施: Enteric Tube (Device)
CORTRAK enteral access system (CEAS) placement
An electromagnetic device used to enable enteral nutrition tube placement
干预措施: CORTRAK enteral access system (Device)
结局指标
主要结局
Duration of Time
时间窗: Baseline to End of procedure up to 30 minutes
Time taken for placement of enteral tube
次要结局
- Number of X-Rays(Baseline to End of procedure up to 30 minutes)
研究者
Andrew D. Meyer
Andrew Meyer, MD
The University of Texas Health Science Center at San Antonio