Functionality and Accuracy of the smARTrack System in Real-Life ICU Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- System accurately guides correct initial placement
研究概览
简要总结
This study conducted in order to validate the functionality and accuracy of the smARTrack™ System in a real-life ICU setting. The smARTrack™ Feeding Tube System is a novel system with nasogastric tube developed by ART Healthcare Ltd, based on sensor-lined tubes that transmit real-time information to an external console. The smARTrack™ feeding tube is equipped with reflux sensors which alert when gastric contents regurgitating into the esophagus. In addition, the smARTrack™ feeding tube is equipped with sensors designed to provide information about the location of the tube thus assisting in reducing the incident of misplacement during first positioning. The smARTrack™ feeding tube is also automatically and in real-time stops feeding if the feeding tube moves out of position during ongoing use or detect gastric content in esophagus. Furthermore, smARTrack™ Feeding Tube System can guide operator to correctly re-position the tube.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Males and females 18 years or older
- •Patient has already been admitted to ICU
- •Patient requires enteral feeding
- •Patients receiving PPI therapy
- •Informed consent by independent physician and next of kin
- •ICU ventilated patients
排除标准
- •Patients with anomalies or diseases of the nose, throat, or esophagus and or stomach.
- •Patients with known sensitivities or allergies to any of the feeding tube materials
- •Inability to place patient is semi-Fowler's position.
- •Any clinically significant abnormality upon physical examination which may, in the opinion of the investigator, pose difficulty in inserting the feeding tube (e.g. cervical spine disorder)
- •Pregnancy
- •Recent abdominal surgery (less than 30 days)
研究组 & 干预措施
General
One arm study: smARTrack Feeding Tube System.
干预措施: smARTrack Feeding Tube System (Device)
结局指标
主要结局
System accurately guides correct initial placement
时间窗: 24-72 hours
The system is able to accurately guide the user to ensure correct initial placement (verified by X-ray)
System accurately detects tube movement/displacement during ongoing use
时间窗: 24-72 hours
The system is able to detect tube movement/displacement during ongoing use (verified by markings on the tube)
System automatically stops feeding when displacement is detected
时间窗: 24-72 hours
The system automatically stops feeding when tube displacement is detected
System is able to detect overfeeding
时间窗: 24-72 hours
The system is able to detect overfeeding
Occurrence of device related Adverse Events (Safety)
时间窗: 24-72 hours
Occurrence of device related adverse events
次要结局
- Aspiration of gastric contents percentage compared to standard feeding (as reported in literature)(24-72 hours)
- Correlation between patient clinical information and the occurrence of reflux and sensors data(24-72 hours)
- The system user interface is easy for use(24-72 hours)
- Correlation of impedance detected to patient positioning(24-72 hours)
- Quantification of the amount of discarded nutritional supplement by implementing GRV test(24-72 hours)