Disposable Respiratory Flow Measurement Device

描述（由申请人提供）：该项目的总体目标是开发，正式基准测试和验证一种新的流量传感器，该传感器将准确量化儿科和成人患者群体的不同程度的通气。流量传感器是一种简单的、非接触的、一次性的部件，即使在低流量范围内也能提供呼吸活动的定量测量。目前的技术缺乏精确测量潮汐量的能力，只能提供呼吸模式的半定量测量。肺记录仪（可以提供定量数据）对患者的舒适度和呼吸努力来说过于繁重，无法获得长期的呼吸测量。在提交拨款之前，他们已经自行开发了初步原型，并在巴尔的摩的约翰霍普金斯睡眠障碍中心进行了测试。原型机的性能可与金标准（气记录仪）相媲美。本项目将完成设计的开发，正式用气压记录仪对流量传感器进行基准测试，并检验设计的稳定性和准确性。在此之后，设计将进行与患者舒适度和依从性相关的计划改进。该项目将在夜间睡眠诊所进行正式的临床验证研究，以比较和验证新的流量传感器与现有技术。最终的设计修改将集中在“即插即用”接口的优化上，从而简化与现有多导睡眠图记录单元的集成，提高技术人员的易用性和患者的舒适度。该应用程序产生的数据和原型最终将转化为对易患呼吸衰竭的患者的改进护理，并最终作为家庭环境中患者的门诊诊断系统。这种流量传感器将对睡眠实验室的患者监测产生直接影响，并将进一步影响肺部医学、麻醉和其他医学学科的诊断程序。

DESCRIPTION (provided by applicant): The overall goal of this project is to develop, formally benchmark and validate a new flow sensor that will accurately quantify varying degrees of ventilation in pediatric and adult patient populations. The flow sensor is a simple, non-contact, disposable part that provides quantitative measurement of respiratory activity, even in the low-flow range. Current technologies lack the ability to accurately measure tidal volume but rather provide a semi-quantitative measure of respiratory patterns. A pneumotachograph (which can provide quantitative data) is too burdensome on patient comfort and breathing effort to obtain long term respiration measurements. Self-funded preliminary prototypes were developed prior to this grant submission and tested at the Johns Hopkins Sleep Disorders Center in Baltimore. The prototypes performed comparable to the gold standard (pneumotachograph). This project will finish development of the design, formally benchmark the flow sensor with the pneumotachograph, as well as examine the stability and accuracy of the design. Following this, the design will undergo planned improvements related to patient comfort and compliance. The project will conclude with formal clinical validation studies at overnight sleep clinics across a spectrum of patients to compare and validate the new flow sensor to current technology. Final design modifications will focus on optimization of a "plug-and-play" interface thereby simplifying integration with existing polysomnographic recording units and improving technician ease of use and patient comfort. The data and prototypes generated by this application will ultimately translate into improved care of patients that are susceptible to ventilatory failure and eventually as an ambulatory diagnostic system for patients in the home setting. This flow sensor will have an immediate impact on patient monitoring in sleep laboratories and will further influence diagnostic procedures in pulmonary medicine, anesthesia and other medical disciplines.