TubeClear System Evaluation in Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Behavioral Response
研究概览
简要总结
Enteral access devices (EADs) provide necessary hydration, nutrition, and medications to numerous patients in hospitals across the United States. When patient's EAD becomes clogged it can delay administration of important nutrition and medications which can cause adverse effects such as malnutrition, and dehydration, especially in pediatric patients. Traditional methods of unclogging EADs can require the use of special enzymes or chemicals but these produce a variable rate of success. The TubeClear system has been developed to help alleviate the need for use of special enzymes or chemicals and to provide a quick, safe alternative for those with a clogged or sluggish EAD all while at the patient's bedside. This system prevents the need for subsequent exposure to radiation and contrast media for confirmation of EAD location after replacement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females under the age of 18 for the entire duration of the study procedure and follow up with an occluded (partial/sluggish or fully blocked) EAD
- •Indwelling EAD must be NE, NG, NJ tube composed of PVC or polyurethane and is 6-18 FR, 38-140 cm
- •NG tube being used as a J tube inserted through a G tube and is 6-18 Fr; 38-140 cm
- •G and J tubes 10-18 Fr; 20-36cm
- •Specific GJ tubes: G-Jet, MIC, and MIC-KEY Tubes that are size 14-22Fr and have a jejunal length of 15-45cm
排除标准
- •Wards of the State
- •Positive urine pregnancy test/pregnant females or inability to take a pregnancy test
- •Any active gastrointestinal abnormalities, including but not limited to infections, inflammation, and/or recent abdominal surgery (except for recent gastrostomy placement) or trauma
- •Constant dependency on the EAD for glucose source
- •Unable to tolerate water volume needed for EAD flush
- •Unknown length of EAD
- •Attending physician declines enrollment based on clinical judgment
- •Subject turns 18 years of age during study duration
- •Very low birth weight (<1.5kg)
研究组 & 干预措施
TubeClear
This is an open label study without a control group. It is designed to evaluate the safety and efficacy of TubeClear in patients with occluded (partial/sluggish or fully blocked) feeding tubes.
干预措施: TubeClear (Device)
结局指标
主要结局
Behavioral Response
时间窗: Immediately following intervention and Days 1-3
Evaluating the behavioral response to the simultaneous noise and vibration in pediatric patients using behavioral score (0-5)
次要结局
未报告次要终点
研究者
Brenton Reading
Pediatric Radiologist, Division Chief of Interventional Radiology
Children's Mercy Hospital Kansas City