NCT03512145已完成不适用
A Prospective Evaluation of the VIPUN Balloon Catheter 0.2: an Investigational Medical Device for the Monitoring of Gastric Motility in Adult Critically Ill Patients
Prof Dr Jan Tack1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年4月16日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Gastric motility
研究概览
简要总结
An open label, non-randomized, monocentric, interventional investigation in a cohort of adult critically ill patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Signed Informed Consent
- •Of adult age (18 years or older)
- •ICU patients in which enteral nutrition is planned to be initiated and are expected to stay at least 1 day in ICU on enteral feeding.
- •Patients should be mechanically ventilated or have an endotracheal tube or tracheostomy in place.
排除标准
- •Contra-indication for (re-) placement of nasogastric feeding catheters.
- •History of gastric or esophageal surgery
- •Any gastrointestinal surgery or trauma that could significantly increase the risk related to the investigational medical device in the opinion of the investigator
- •Fed by mouth or enterally prior to inclusion
- •Patient is moribund
- •Known pregnancy or breastfeeding women
- •Receives gastroprokinetic medication (e.g., erythromycin, metoclopramide, domperidone)
研究组 & 干预措施
VIPUN Balloon Catheter
Experimental
Recording of gastric motility with the investigational medical device. Gastric emptying rate of a liquid meal is assessed with the 13C-octanoate breath test.
干预措施: VIPUN Balloon Catheter (Device)
结局指标
主要结局
Gastric motility
时间窗: 10 hours
Assessed with the VIPUN Balloon Catheter
gastric emptying rate
时间窗: 6 hours
Assessed with 13C-octanoate breath test
次要结局
- Safety parameters potentially related to the use of the investigational medical device(Day 0 until day 30)
- Success rate placement and removal balloon catheter(Day 0 until day 1 (<24 h))
研究者
Prof Dr Jan Tack
Member of staff hepato-gastroenterology
Universitaire Ziekenhuizen KU Leuven
研究点 (1)
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