Optical Detection of Intravenous Infiltration

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DESCRIPTION (provided by applicant): In the United States, about 80% of hospital patients require IV therapy and about 50% of IV lines fail due to infiltration, a clot in the cannula, an inflammatory response of the vein, or separation of the cannula from the vein. IV infiltration is usually accompanied by pain, erythema, and/or swelling at the cannula tip or the insertion site. Severe infiltration may lead to necrosis requiring skin debridement, skin grafting, or amputation. One common area of malpractice lawsuits filed against physicians and nurses involves infiltration. The leakage of cytotoxic drugs, intravenous nutrition, solutions of calcium, potassium, and bicarbonate, and even 10% dextrose outside the vein into which they are delivered is known to cause skin necrosis and to precipitate significant scarring around joints. Early detection of infiltration prevents the occurrence of serious incidents that may require surgical correction. The long-term objective of the project is to provide an accurate, reliable, and low-cost tool that allows objective assessment of IV infiltrations. Specific aims of the Competing Continuation effort are: to refine the IV infiltration detection device, to conduct a clinical trial, and to submit a 510 (k) application to the U.S. Food and Drug Administration.