APD to Measure the Resistance of the Respiratory System

APD 测量呼吸系统阻力

基本信息

批准号：
7486329
负责人：
JAFAR VOSSOUGHI
金额：
$ 43.14万
依托单位：
ENGINEERING AND SCIENTIFIC RESEARCH ASSO
依托单位国家：
美国
项目类别：
财政年份：
2004
资助国家：
美国
起止时间：
2004-09-16 至 2011-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7486329
关键词：
Adult Ambulances Breathing Cause of Death Child Chronic Chronic Obstructive Airway Disease Chronic Obstructive Asthma Clinic Clinical Data Clinics and Hospitals Data Devices Diagnosis Exhalation Funding Health Health Care Costs Health Professional Healthcare Home environment Individual Interruption Intervention Life Lung diseases Marketing Measurement Measures Mechanical Ventilators Monitor Operative Surgical Procedures Oral cavity Patients Pharmaceutical Preparations Pharmacologic Substance Phase Physicians&apos Offices Production Pulmonary function tests Resistance Respiration Disorders Respiratory System Screening procedure Spirometry Standards of Weights and Measures Testing Therapeutic Therapeutic Intervention Time Today United States Weight concept cost improved older patient patient home care pressure respiratory sensor size

项目摘要

DESCRIPTION (provided by applicant): Respiratory screening and diagnosis are important in today's health care. Asthma and chronic obstructive pulmonary disease (COPD) constitute major health problems in the US. Mechanical ventilators are used increasingly for life support in patients with serious respiratory illness. Traditional pulmonary function tests (spirometry) are often not adequate to provide the respiratory functional information required by health care professionals. The Airflow Perturbation Device (APD) has undergone significant improvements over several years. APD is simple in concept, employing a rotating wheel in the flow path to change flow by 20-45%, with associated small changes in mouth pressure. From these changes, resistance is calculated. APD is simple in operation, requiring only normal breathing for one minute and is useful in children as well as adults. APD can display resistance changes in real time, and can be modified to measure resistance of ventilated patients and made as portable as a camera. We have used APD it its current implementation to measure average respiratory resistance, as well as separate inspiratory and expiratory values, in nearly 1,500 people. The Phase I clinical data shows that the Standard Deviation (SD) for APD is smaller than IOS on identical measurements. Existing competitive commercial Pulmonary Function Testing (PFT) devices include spirometry, forced oscillation (FO, e.g. IOS), and interrupter (Rint). These either require patients to forcefully exhale (spirometers), or are very expensive and very sensitive to airflow leak (forced oscillation, FO, such as IOS), or require complete interruption of airflow limiting data acquired to only one measurement every 3 breaths (Rint). Three major advantages of APD include a requirement for natural breathing only, relatively less effect from airflow leak than in FO, and it provides an order of magnitude more measurements than Rint. APD can be used by young children, ill adults and in elderly patients. Phase I funding enabled us to considerably advance APD to its current configuration. Pre-Phase I APD weight/cost were 10 pounds/$3,500. APD is now 14.7 ounces/$600, and portable. In Phase II we plan to further reduce its size and cost, improve the flow sensor's accuracy and sensitivity, and add additional capabilities including flow-volume display. To bring APD into commercial production (our long term objective), further refinements are necessary. After that, clinical data must be obtained, and regulatory approval must be sought. The market for the APD is huge, including hospitals, clinics, physician's offices, ambulances, and home care facilities. Because of its size and cost and ease of operation, the APD is an ideal device for home use and for pharmaceutical testing of new drugs. In Phase II we plan to test the device on at least 1,750 individuals at 4 different clinics. Chronic obstructive pulmonary disease (COPD) is fourth leading cause of death in the United States; and respiratory screening for Asthma and COPD, and monitoring of therapeutic interventions are important in US health care. Because of its small size, modest cost, ease of operation and sensitivity to small airway function, the proposed device (APD) can effectively and economically screen for respiratory disease, and monitor interventions in patients with COPD and other respiratory disorders. This will improve diagnosis and recognition of therapeutic benefits as well as lower the cost of the health care.

描述（由申请人提供）：在当今的医疗保健中，呼吸筛查和诊断很重要。在美国，哮喘和慢性阻塞性肺疾病（COPD）构成了主要的健康问题。机械呼吸机越来越多地用于严重呼吸道疾病的患者的生命支持。传统的肺功能测试（肺活量测定法）通常不足以提供卫生保健专业人员要求的呼吸功能信息。气流摄动装置（APD）在几年内经历了重大改进。 APD在概念上很简单，在流动路径中采用旋转轮，将流动变化20-45％，与口感相关的小变化。通过这些变化，计算电阻。 APD的运行简单，仅需要一分钟的正常呼吸，并且对儿童和成人都有用。 APD可以实时显示电阻变化，并且可以修改以测量通风患者的阻力并像相机一样便携。我们已经使用了当前的实施方法来衡量近1,500人的平均呼吸阻力以及单独的灵感和呼气值。 I期临床数据表明，在相同的测量中，APD的标准偏差（SD）小于iOS。现有的竞争商用肺功能测试（PFT）设备包括肺活量测定法，强制振荡（FO，例如iOS）和Interupter（RINT）。这些要么要求患者强行呼气（肺活量计），要么非常昂贵，并且对气流泄漏（强制振荡，FO，例如iOS）非常敏感，或者需要完全中断每3次呼吸（RINT）获得的气流限制数据仅获得一次测量。 APD的三个主要优势包括仅对天然呼吸的要求，与FO相比，气流泄漏的影响相对较小，并且比RINT提供的测量范围更高。幼儿，生病的成年人和老年患者可以使用APD。第一阶段的资金使我们能够大大提高APD的当前配置。 IPD前的体重/成本为10磅/$ 3,500。 APD现在为14.7盎司/$ 600，并且便携式。在第二阶段，我们计划进一步降低其大小和成本，提高流动传感器的准确性和灵敏度，并添加其他功能，包括流量显示器。为了将APD带入商业生产（我们的长期目标），需要进一步的改进。之后，必须获得临床数据，并且必须寻求法规批准。 APD的市场很大，包括医院，诊所，医师办公室，救护车和家庭护理设施。由于其规模，成本和易于操作，APD是家庭使用和新药测试的理想设备。在第二阶段，我们计划在4个不同诊所的至少1,750个人上测试该设备。慢性阻塞性肺疾病（COPD）是美国的第四大死亡原因。哮喘和COPD的呼吸筛查以及对治疗干预措施的监测在美国医疗保健中很重要。由于其尺寸较小，成本适中，操作易于操作和对小气道功能的敏感性，建议的装置（APD）可以有效地筛选出呼吸道疾病的筛查，并监测COPD和其他呼吸系统疾病患者的干预措施。这将改善对治疗益处的诊断和认识，并降低医疗保健的成本。