System for Monitoring Turning/Repositioning Therapy

DESCRIPTION (provided by applicant): Pressure injury in high-risk patients is an important and potentially costly nosocomial complication of hospital therapy. This proposed project will be a collaborative effort between Sarcos Research Corporation (SRC) and the LDS Hospital in Salt Lake City in developing and clinically testing a wireless sensor system for scheduling and monitoring turning/repositioning therapy in high-risk patients. When completed, this project will result in a system that (1) will have been clinically tested and engineered for economical production, (2) for which the 510(k) application will have been submitted, (3) will be available for multicenter clinical studies, and (4) will be ready for immediate commercialization in Phase 3. The proposed system will provide health care institutions with (1) a longitudinal record of patient position changes while in bed, (2) an alert signal that turning/positioning is needed after a programmable time interval, and (3) a reminder that patient position has not changed at a prescribed interval, or that patient position has suddenly changed, thereby immediately alerting staff to impending or actual danger to the patient. The system will be economical in acquisition and use, and will lower the costs of pressure injury prevention in high risk patients. Phase 1 will determine the optimum sensor attachment position in volunteers. The development will be conducted in collaboration between SRC and the clinical team at the LDS Hospital. In this phase, we will conduct a study in volunteers and develop engineering designs for the sensor and the sensor attachment to the body. The designs will be evaluated by the clinical team and the Phase 1 testing will show whether the attached sensor accurately indicates turning/repositioning in hospital bed. In this phase, engineering design of the system, the system prototype and developmental study in volunteers will be completed. Phase 1 will be completed in 4-6months period of time