Accuracy of Ultrasound for the Evaluation of Percutaneous Gastrostomy Tube Position and Leakage
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Proportion of Ultrasound that Agree with Fluoroscopy with Respect to Identifying the GT Location
研究概览
简要总结
The goal of this clinical trial is to compare using ultrasound imaging to look at the position of the gastrostomy tube (GT) against fluoroscopic imaging in pediatric patients who had a recent GT tube replacement.
The main questions it aims to answer are:
- If ultrasound is just as accurate as fluoroscopy to assess the GT position.
- If ultrasound takes less time than fluoroscopy to assessing the GT position.
Participants will be imaging using ultrasound to assess GT positioning before their standard of care fluoroscopic imaging.
详细描述
This clinical trial will address the validity of using ultrasound to evaluate the position of the gastrostomy tube (GT) retention balloon against the clinical gold standard of fluoroscopic tube injection to assess for potential larger studies and the implementation in clinical practice. This study will address the ability to visualize the retention balloon within the gastric lumen, the ability to assess for leakage from the GT within the abdomen, and the relative length of each study to perform.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •An individual who presents with a dislodged GT and meets one of the following minor criteria:
- •Surgical GT placement less than 90 days from presentation
- •Traumatic GT dislodgement/removal
- •Recent stoma dilation
- •Clinician uncertainty about position of GT placement
排除标准
- •An individual >18 years of age
- •Acutely ill patients defined as hemodynamically unstable defined as any child who has abnormal vital signs or disruption of vital functions (i.e. airway, breathing, circulation, mental function). Vital signs are based on patient age. Initial assessment of clinical patient stability will be provided by the ordering/referring provider.
研究组 & 干预措施
Ultrasound Imaging
This study consists of one group/ All participants will receive ultrasound imaging prior to the standard of care fluoroscopic imaging.
干预措施: Ultrasound Imaging (Device)
结局指标
主要结局
Proportion of Ultrasound that Agree with Fluoroscopy with Respect to Identifying the GT Location
时间窗: Upon completion of all study image data collection for all participants [approximately 1 year]
Proportional accuracy of ultrasound in identifying the gastrostomy tube (GT) balloon location based on the readers' (radiologists) ability to use the ultrasound to locate the GT balloon in comparison with the gold standard (fluoroscopic tube injection).
次要结局
- Sensitivity of ultrasound (US) to determine the visualization of GT leakage(Upon completion of all study image data collection for all participants [approximately 1 year])
- Specificity of ultrasound (US) to determine the visualization of GT leakage(Upon completion of all study image data collection for all participants [approximately 1 year])
- Duration of ultrasound (US) to complete evaluation of GT position(Upon completion of all study image data collection for all participants [approximately 1 year])