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）：呼吸道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（肺活量测定法）通常不足以提供卫生保健专业人员所需的呼吸功能信息。气流扰动装置（APD）在过去几年中经历了重大改进。APD概念简单，在流动路径中采用旋转轮来改变20- 45%的流量，并伴随口腔压力的微小变化。根据这些变化，计算电阻。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可以真实的显示电阻变化，并且可以修改以测量通气患者的电阻，并且可以像相机一样便携。我们在目前的实施中使用APD测量了近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的标准差（SD）小于IOS。现有的竞争性商业肺功能测试（PFT）设备包括肺活量测定、强迫振荡（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，如IOS），要么需要完全中断气流，限制每3次呼吸仅采集一次测量数据（Rint）。APD的三个主要优点包括仅需要自然呼吸，气流泄漏的影响相对小于FO，并且它提供比Rint多一个数量级的测量。APD可用于幼儿、成人患者和老年患者。第一阶段的资金使我们能够大大推进APD到目前的配置。第I阶段前APD重量/成本为10磅/3，500美元。APD现在是14.7盎司/600美元，便携式。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，并增加额外的功能，包括流量显示。为了使APD进入商业化生产（我们的长期目标），需要进一步改进。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、救护车和家庭护理机构。由于其尺寸和成本以及易于操作，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个不同的诊所对至少1,750名患者进行测试。慢性阻塞性肺疾病（COPD）是美国第四大死亡原因;哮喘和COPD的呼吸道筛查以及治疗干预的监测在美国医疗保健中非常重要。由于其体积小、成本适中、易于操作和对小气道功能的敏感性，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COPD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。