NCT05884216终止不适用
Entarik Feeding Tube System Placement in Adult ICU
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Percentage of accurate verifications of anatomical locations of the tip of the Entarik feeding tube. The position of the feeding tube tip as processed by the Entarik placement algorithm will be compared to x-ray.
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of the Entarik Feeding Tube System in an adult ICU patient population for the administration of nutrition, fluids and medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be able to swallow tabletsAt least 18 years old
- •Able to provide informed consent or ability to have a legally authorized representative provide informed consent
- •Adults in the ICU requiring an 8Fr, 10Fr, or 12Fr NG tube. The size of the feeding tube should be determined clinically, and the Entarik Feeding Tube should only be placed if that size is appropriate.
- •Suitable to start enteral (gastric but no post-pyloric) feeding
- •Anticipated to receive enteral feeding (either bolus or continuous feeds) for more than 6 hours and conclude the enteral nutrition while in the care of the ICU. If enteral nutrition has already been initiated, indicated for replacement of an NG feeding tube Note: Both subjects on a ventilator (non-invasive or invasive ventilation) or not requiring a ventilator are eligible for this study.
排除标准
- •inability to receive a feeding tube including subjects with known history of issues such as esophagitis or strictures, frequent nose bleeds, basilar skull fracture or GI bleeding disorders
- •Known major upper airway malformation
- •Known major GI abnormality, upper GI malignancy, or partial gastric resection
- •History of gastroparesis
- •Currently pregnant
- •NPO status - expected to remain NPO for the following 72 hours.
- •Patient needs an MRI in the immediate future (e.g., 6-12h) where placement of the feeding tube (non-MRI compatible) is going to mandate replacement with standard feeding tube
- •Critically ill, facing imminent death
- •Deemed unsuitable for enrollment in study by the investigator based on subject's history (e.g., active anticoagulation therapy) or physical examination
研究组 & 干预措施
Entarik
Experimental
Entarik FT System guided placement
干预措施: Entarik Feeding Tube System (Device)
Control
Active Comparator
Entarik Ft placement placement not guided with monitor
干预措施: Entarik Feeding Tube System without monitoring (Device)
结局指标
主要结局
Percentage of accurate verifications of anatomical locations of the tip of the Entarik feeding tube. The position of the feeding tube tip as processed by the Entarik placement algorithm will be compared to x-ray.
时间窗: 1 year
All patients will receive placement verification per institutional standard of care.
次要结局
未报告次要终点
研究者
研究点 (4)
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