APD to Measure the Resistance of the Respiratory System

APD 测量呼吸系统阻力

• 批准号: 7329052
• 负责人: JAFAR VOSSOUGHI
• 金额: $ 47.41万
• 依托单位: ENGINEERING AND SCIENTIFIC RESEARCH ASSO
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-16 至 2009-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7329052
• 关键词: Adult; Air; Ambulances; Breathing; Categories; Cause of Death; Characteristics; Child; Chronic; Chronic Obstructive Airway Disease; Chronic Obstructive Asthma; Clinic; Clinical; Clinical Data; Clinical Trials; Clinics and Hospitals; Collaborations; Communication; Compatible; Computer software; Computers; Data; Data Storage and Retrieval; Development; Devices; Diagnosis; Diagnostic; Documentation; Exercise; Exhalation; Frequencies; Funding; Graph; Hand; Health; Health Care Costs; Health Personnel; Health Professional; Healthcare; Home environment; Hospitals; Individual; Interruption; Intervention; Laboratories; Life; Lung; Lung diseases; Marketing; Measurement; Measures; Mechanical Ventilators; Mechanics; Medical; Miniaturization; Monitor; Noise; Nose; Occupational; Operating System; Operative Surgical Procedures; Oral cavity; Oscillometry; Patients; Peripheral; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Physicians' Offices; Production; Pulmonary function tests; Resistance; Respiration Disorders; Respiratory System; Respiratory physiology; Rest; Sales; Screening procedure; Secure; Series; Signal Transduction; Specialist; Spirometry; Standards of Weights and Measures; System; Testing; Therapeutic; Therapeutic Intervention; Time; Today; United States; United States Food and Drug Administration; Week; Weight; Work; base; concept; cost; expiration; improved; laptop; older patient; patient home care; pressure; programs; pulmonary function; respiratory; respiratory airflow measurement; sensor; size; software development

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）：呼吸系统筛查和诊断在当今的医疗保健中非常重要。哮喘和慢性阻塞性肺病（COPD）是美国的主要健康问题。机械呼吸机越来越多地用于严重呼吸系统疾病患者的生命支持。传统的肺功能测试（肺活量测定）通常不足以提供医疗保健专业人员所需的呼吸功能信息。气流扰动装置 (APD) 多年来经历了重大改进。 APD 的概念很简单，在流路中采用旋转轮将流量改变 20-45%，同时口腔压力发生微小变化。根据这些变化，可以计算出阻力。 APD 操作简单，只需正常呼吸一分钟，对儿童和成人都很有用。 APD可以实时显示阻力变化，并且可以进行修改以测量通气患者的阻力，并使其像相机一样便携。我们使用当前实施的 APD 来测量近 1,500 人的平均呼吸阻力，以及单独的吸气和呼气值。 I 期临床数据显示，在相同测量值下，APD 的标准偏差 (SD) 小于 IOS。现有的具有竞争力的商业肺功能测试 (PFT) 设备包括肺量计、受迫振荡 (FO，例如 IOS) 和中断器 (Rint)。这些要么需要患者用力呼气（肺活量计），要么非常昂贵且对气流泄漏非常敏感（强制振荡，FO，例如 IOS），或者需要完全中断气流，限制每 3 次呼吸仅获取一次测量数据（Rint ）。 APD 的三大优点包括仅需要自然呼吸、与 FO 相比，气流泄漏的影响相对较小，并且它提供的测量值比 Rint 多一个数量级。 APD 可供幼儿、成人和老年患者使用。第一阶段的资金使我们能够将 APD 大幅推进到当前的配置。第一阶段之前的 APD 重量/成本为 10 磅/3,500 美元。 APD 现在为 14.7 盎司/600 美元，并且便于携带。在第二阶段，我们计划进一步减小其尺寸和成本，提高流量传感器的精度和灵敏度，并添加包括流量显示在内的附加功能。为了将 APD 投入商业生产（我们的长期目标），需要进一步完善。之后，必须获得临床数据，并寻求监管部门的批准。 APD 的市场巨大，包括医院、诊所、医生办公室、救护车和家庭护理设施。由于其尺寸、成本和操作简便性，APD 是家庭使用和新药药物测试的理想设备。在第二阶段，我们计划在 4 个不同诊所的至少 1,750 人身上测试该设备。慢性阻塞性肺病 (COPD) 是美国第四大死因；哮喘和慢性阻塞性肺病的呼吸道筛查以及治疗干预措施的监测在美国医疗保健中非常重要。由于其尺寸小、成本适中、易于操作且对小气道功能敏感，所提出的设备（APD）可以有效且经济地筛查呼吸系统疾病，并监测慢性阻塞性肺病和其他呼吸系统疾病患者的干预措施。这将改善诊断和对治疗益处的认识，并降低医疗保健成本。