Bedside Ultrasound Assessment of Feeding Tube Position in the Intensive Care Unit: the US-FEED Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 423
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy
研究概览
简要总结
This diagnostic accuracy study aims to evaluate the performance of bedside ultrasound compared to x-ray in detecting the correct position of feeding tubes among critically ill adult patients. The main questions it aims to answer are: • diagnostic accuracy of bedside ultrasound • feasibility of its wide adoption among practitioners with minimal training in busy intensive care units.
详细描述
This multicenter diagnostic accuracy study consists of a non-consecutive convenience sample of adult patients admitted to the intensive care unit starting from March 2023 who require a feeding tube as defined by the medical attending team.
Right after feeding tube placement following the institutional standard operating procedure, attending physicians perform bedside ultrasound assessment to verify the correct position of the tube. They report whether or not visualizing the feeding tube in four steps: 1) in the esophagus from either the right or left side of the patient's neck; 2) in the transverse view of the patient's epigastrium; 3) in the longitudinal view of the patient's epigastrium and 4) during the injection of 20 mL of air into the tube to detect the 'fogging sign.' Finally, the abdominal radiograph (gold standard) confirms the gastric or duodenal placement of the feeding tube.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Age greater than or equal to 18 years old;
- •Need for a tube feeding for receiving diet and/or medication, as indicated by the medical team;
- •Blind insertion of a tube feeding in the intensive care unit, following the standard operating procedure;
- •Presence of a trained physician for ultrasound scanning of the tube feeding immediately after installation.
排除标准
- •Major abdominal postoperative wounds, peritoneostomy, or any other conditions that preclude ultrasound abdominal examination;
- •Exclusive presence of a gastric decompression probe, which does not require radiographic confirmation;
- •Tube feeding introduced under digestive endoscopy guidance;
- •Gestation;
- •Abdominal radiography confirming the tube position obtained before the ultrasound assessment.
结局指标
主要结局
Diagnostic accuracy
时间窗: The expected time between ultrasound assessment and abdominal radiography is under 2 hours..
Estimating sensitivity, specificity, positive predictive rate, negative predictive rate, and total accuracy of bedside ultrasound compared with abdominal radiography (gold standard). A receiver operating characteristic (ROC) curve will display the discriminatory properties of the ultrasound assessment.
次要结局
未报告次要终点