Disposable Respiratory Flow Measurement Device

描述(由申请人提供)：该项目的总体目标是开发、正式基准和验证一种新的流量传感器，该传感器将准确地量化儿童和成人患者群体中不同程度的通风。流量传感器是一种简单的非接触式一次性部件，即使在低流量范围内也能提供呼吸活动的定量测量。目前的技术缺乏准确测量潮气量的能力，而是提供了对呼吸模式的半定量测量。呼吸机(可以提供定量数据)对患者的舒适度和呼吸努力造成太大的负担，无法获得长期的呼吸测量结果。自筹资金的初步原型是在这次拨款申请之前开发出来的，并在巴尔的摩的约翰·霍普金斯睡眠障碍中心进行了测试。样机的性能与黄金标准(气动测速仪)相当。本项目将完成设计的开发，将流量传感器与气动测速仪进行正式基准测试，并对设计的稳定性和准确性进行检验。之后，该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对一系列患者进行正式的临床验证研究，以将新的流量传感器与当前技术进行比较和验证。最终的设计修改将侧重于“即插即用”界面的优化，从而简化与现有多导睡眠记录仪的集成，并提高技术人员的易用性和患者的舒适性。这一应用程序产生的数据和原型最终将转化为对易受呼吸机故障影响的患者的改善护理，并最终成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立竿见影的影响，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.