Neonatal APD, a Simple Noninvasive Diagnostic/Monitoring Device for Neonatal ICU

描述（由申请人提供）：由于技术进步和患者护理的改善，极低出生体重（ELBW）早产儿的存活率大幅提高，导致支气管肺发育不良（BPD）患者数量显著增加。BPD已成为一个主要的公共卫生问题，每年有7,000至10,000个新病例发生。这些早产儿（500至1500克出生体重）在新生儿重症监护病房（NICUs）停留较长时间，并经常接受各种潜在毒性的肺部疾病药物治疗，但没有切实可行的方法来准确确定这种治疗的必要性或监测其有效性。这是因为目前还没有无创肺诊断/监测设备可用于新生儿重症监护病房。我们开发了一种无创肺诊断装置，气流扰动装置（APD），可以在一分钟内无创、快速、轻松地评估患者的呼吸阻力。该装置体积小，便于携带，而且生产成本很低。在NIH NHLBI SBIR资助下，APD得到了极大的增强，目前已进入第二阶段。我们已经对2000多名年龄在2岁到88岁之间的人进行了APD验证。最近，我们利用APD，探索了乔治城大学医院早产儿和足月婴儿呼吸阻力评估的可能性（使用IRB批准的方案）。结果令人鼓舞，并表明，通过一些设备增强（更敏感的压力和流量传感器，减少死区等），APD可以适用于婴儿群体使用。如果成功，它将成为唯一一种可以无创诊断/监测早产儿肺功能的设备。这将填补新生儿重症监护室和门诊诊所的关键需求，允许改善护理和更合理地使用潜在毒性药物。新的增强型设备“新生儿APD”将满足用于新生儿的设备的严格要求（高灵敏度，低死区，轻松地与口罩一起使用）。最终产品将是一种可靠的设备，可以快速、廉价地诊断/监测婴儿肺功能，无需患者积极配合。所提出的工作包括工程和临床两部分。工程方面的工作包括改进和增强现有的APD，使其具有足够的灵敏度，可以在20秒内可靠地检测小婴儿的口压和流量，减少死区。在临床部分，我们将评估200例早产儿和足月儿的呼吸阻力。研究对象包括正常婴儿、BPD患者和其他呼吸系统疾病患者。我们将对接受支气管扩张剂、利尿剂、咖啡因等治疗的婴儿进行研究，以证明该设备检测气道阻力变化的能力。本申请是根据申请“RFA-HD-09-017；新生儿重症监护病房使用的安全有效的仪器和设备（SBIR [R43]）”。

DESCRIPTION (provided by applicant): Due to technological advances and improvements in patient care the survival rate of the extremely low birth weight (ELBW) preterm infants has increased substantially, resulting in a significant increase in the number of patients with bronchopulmonary dysplasia (BPD). BPD has become a major public health problem with 7,000 to 10,000 new cases occurring each year. These preterm infants (500 to 1,500 g birth weight) remain in Neonatal Intensive Care Units (NICUs) for extended periods and often receive a variety of potentially toxic medications for their lung disease with no practical way of accurately determining the need for such treatment or monitoring its effectiveness. This is because currently, there is no non-invasive pulmonary diagnostic/monitoring device available for NICU use. We have developed a non-invasive pulmonary diagnostic device, Airflow Perturbation Device (APD) that can evaluate the respiratory resistance of patients non-invasively, rapidly, and effortlessly in less than one minute. The device is small, portable and can be produced at a very low cost. The APD has been considerably enhanced using the NIH NHLBI SBIR grant, now at the end of its Phase II term. We have validated the APD on over 2,000 individuals aged 2 to 88 years. Recently, using the APD, we have explored the possibility of evaluating respiratory resistance of preterm and full term infants at Georgetown University Hospital (using an IRB approved protocol). The results are encouraging and indicate that, with some device enhancement (more sensitive pressure and flow transducers, reduced dead space, etc), the APD can be adapted for infant population use. If successful, it will be the only device that can non-invasively diagnose/monitor the pulmonary function of preterm infants. This would fill a critical need in the NICU and outpatient clinic, allowing for improved care and more rational use of potentially toxic medications. The new enhanced device, the "Neonatal APD", will meet the stringent requirements for a device for use in newborns (high sensitivity, low dead space, used with a face mask effortlessly). The final product will be a reliable device that can diagnose/monitor infant pulmonary function quickly, inexpensively and without active patient cooperation. The work proposed consists of two parts, engineering and clinical. The engineering aspect of the work includes modification and enhancement of the existing APD with sufficient sensitivity to detect the small infant mouth pressure and flow reliably in 20 seconds, reducing dead space. In the clinical part we will evaluate respiratory resistance of 200 preterm and full term infants. The subjects will include normal infants, those with BPD and other respiratory disorders. We will study infants receiving bronchodilators, diuretics, caffeine, etc. to demonstrate the ability of the device to detect changes in airway resistance in response to these therapies. This application is prepared in response to the request for application "RFA-HD-09-017; Safe and Effective Instruments and Devices for use in the Neonatal Intensive Care Units (SBIR [R43])". PUBLIC HEALTH RELEVANCE: There is a high incidence of bronchopulmonary dysplasia (BPD) in extremely low birth weight infants that has become a major public health problem with 7,000 to 10,000 new cases occurring each year. Currently there is no non-invasive device to diagnose/monitor these infants. We have developed such a device (APD) that works perfectly for children and adults. We are proposing to enhance the APD for use in infant population that will be non-invasive, sensitive, reliable and inexpensive. The new device, Neonatal APD will be a useful tool in Neonatal Intensive Care Units.