System for Monitoring Turning/Repositioning Therapy

监测翻转/重新定位治疗的系统

• 批准号: 6883405
• 负责人: Tomasz J Petelenz
• 金额: $ 10.59万
• 依托单位: STERLING RESEARCH CORPORATION
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-16 至 2007-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6883405
• 关键词: accidental falls; behavioral /social science research tag; biomedical equipment development; clinical biomedical equipment; clinical research; computer assisted patient care; computer human interaction; computer system design /evaluation; cost effectiveness; decubitus ulcer; health services research tag; human subject; human therapy evaluation; iatrogenic disease; information display; injury prevention; intensive care; nursing care; patient monitoring device; patient oriented research; patient safety /medical error; skin irritation /irritant; telemetry

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

描述（由申请人提供）：高危患者的压力损伤是医院治疗的重要且可能昂贵的医院并发症。 这个拟议的项目将是Sarcos Research Corporation（SRC）与盐湖城LDS医院之间的合作努力，以开发和临床测试无线传感器系统，用于调度和监测高危患者的转弯/重新定位疗法。 完成后，该项目将导致（1）将对经济生产进行临床测试和设计，（2）将为510（k）申请提交，（3）将用于多中心临床研究，（4）将准备好在第3阶段中立即进行商业化。 拟议的系统将为（1）在床上旁边的患者位置变化的纵向记录，（2）警报信号，表明在可编程时间间隔后需要转动/定位，以及（3）提醒患者的位置没有在处方间隔内发生变化，或者突然改变患者，以使工作人员立即改变了即时的患者或实际的危险或实际的危险。该系统在获取和使用方面将是经济的，并将降低高风险患者预防压力损伤的成本。 第1阶段将确定志愿者中的最佳传感器附着位置。该开发项目将在SRC与LDS医院的临床团队之间合作进行。在此阶段，我们将对志愿者进行一项研究，并为传感器和传感器的附件开发工程设计。这些设计将由临床团队评估，第一阶段测试将显示附件的传感器是否准确表明在医院病床中转动/重新定位。在此阶段，将完成系统的工程设计，系统原型和志愿者的发展研究将完成。 第1阶段将在4-6个月的时间内完成