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NASO-GASTRIC FEEDING TUBE PLACEMENT VERIFICATION SYSTEM

鼻胃饲管放置验证系统

基本信息

批准号：
2431416
负责人：
Robert Neal Golden
金额：
$ 29.05万
依托单位：
LUCENT MEDICAL SYSTEMS, INC.
依托单位国家：
美国
项目类别：
财政年份：
1994
资助国家：
美国
起止时间：
1994-07-01 至 1999-05-14
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/2431416
关键词：
biomedical equipment development biosensor device clinical biomedical equipment clinical research gastrointestinal imaging /visualization human subject magnetic field tube feeding

项目摘要

Naso-gastric (NG) feeding tubes are used to deliver nutrition to patients who cannot eat for themselves in nursing homes, hospitals, and home care settings. Improper placement into the esophagus, lungs or trachea of NG tubes by caregivers can result in complications, including pneumonia and death. Currently, the only certain method of proper NG tube placement is radiographic - an X-ray film is taken of the abdomen to verify the location of the NG tube. However, X-rays deliver a radiation dose are time consuming and are relatively expensive. A hand-held, non-radiographic, NG tube position verification system would improve patient care in many situations by reducing both risks and cost. During Phase II the prototype system consisting of a magnetic-field detector and magnet-tipped NG tubes, developed during phase I will be refined and tested. The Tube Finder detector will be developed into a self-contained hand-held unit with an onboard controller and display. The detector and magnet-tipped tubes will be used in preliminary clinical trials to establish the system's accuracy and reliability relative to X-ray verification, and to begin fulfilling FDA licensing criteria. PROPOSED COMMERCIAL APPLICATION: It is estimated that about 7 million NG feeding tubes are placed into patients per year in the U.S. and that of least 10% of these are inserted with X-ray confirmation. X-ray confirmation costs to the hospital or patient range from $80 to $100 - giving an approximate health care cost of over $60 million. A large percentage of this cost (and associated physician time) would be eliminated by the proposed non-radiographic system. In addition, this system would allow NG tubes to be confidently placed in patients where there is no ready access to X-ray equipment for example in nursing homes or in the patient's own home.

鼻胃（NG）饲管用于向患者输送营养在疗养院、医院和家庭护理中无法自己吃饭的人设置. NG的食管、肺或气管放置不当护理人员的插管可能导致并发症，包括肺炎，死亡目前，正确放置NG管的唯一确定方法是放射学-拍摄腹部X光片以验证位置的NG管。然而，X射线提供的辐射剂量是时间消耗量大，相对昂贵。手持式非射线照相NG 管位置验证系统将在许多方面改善患者护理降低风险和成本。在第二阶段，原型系统由磁场组成，探测器和磁铁尖NG管，在第一阶段开发将是精炼和测试。该探测器将被开发成一种自带控制器和显示器的独立手持设备。的探测器和磁头管将用于初步临床试验以确定系统相对于X射线的准确性和可靠性验证，并开始履行FDA许可标准。建议的商业应用：预计约700万NG 在美国，其中至少10%是通过X光确认插入的。 x射线医院或病人的确认费用从80美元到100美元不等，估计医疗费用超过六千万美元大这一成本的百分比（和相关的医生时间）将被消除通过拟议的非射线照相系统。此外，该系统将使NG管可以放心地放置在患者体内，使用X射线设备，例如在疗养院或患者的自己的家