SBIR-STTR Award

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 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 tip 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. A prototype non-radiographic, NG tube verification system will be developed. It will be based around a technology licensed from the University of Washington, Seattle. The specific Phase I goal is to establish the feasibility and costs of a system using this technology. The prototype will be refined and developed into a hand-held unit. It will be used in preliminary clinical trials to establish the system's accuracy relative to X-ray verification and to begin fulfilling FDA licensing criteria.National Center for Research Resources (NCRR)

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.

Thesaurus Terms:
biomedical equipment development, clinical biomedical equipment, tube feeding biosensor, clinical trial phase II /III /IV, gastrointestinal visualization, magnetic field clinical research, human subject