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

描述(申请人提供)：由于技术的进步和病人护理的改善，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)患者的数量显著增加。BPD已成为一个主要的公共卫生问题，每年新增7000至10000例。这些早产儿(出生体重500至1500克)长期留在新生儿重症监护病房(NICU)，经常接受各种可能有毒的肺部疾病药物治疗，没有实际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非侵入性的肺部诊断/监测设备可供NICU使用。我们开发了一种非侵入性肺部诊断设备--气流微扰仪，它可以在不到一分钟的时间内无创、快速、毫不费力地评估患者的呼吸阻力。该设备体积小，携带方便，生产成本非常低。通过NIH NHLBI SBIR赠款，apd得到了极大的加强，现已进入第二阶段。我们已经对2,000多名年龄在2岁到88岁之间的人进行了警察局的验证。最近，我们探索了在乔治敦大学医院(使用IRB批准的方案)评估早产儿和足月儿呼吸阻力的可能性。结果是令人鼓舞的，并表明，通过一些设备的改进(更灵敏的压力和流量传感器，减少死腔等)，apd可以适应婴儿人群的使用。如果成功，这将是唯一可以非侵入性诊断/监测早产儿肺功能的设备。这将满足NICU和门诊的迫切需求，允许改善护理和更合理地使用潜在有毒药物。这款新的增强型设备--“新生儿防护器”--将满足新生儿使用设备的严格要求(高灵敏度、低死腔、轻松地与面罩配合使用)。最终的产品将是一种可靠的设备，可以快速、廉价地诊断/监测婴儿的肺功能，而不需要积极的患者合作。建议的工作包括工程和临床两部分。这项工作的工程方面包括对现有的apd进行修改和增强，使其具有足够的灵敏度，能够在20秒内可靠地检测到小婴儿的口腔压力和流量，减少死腔。在临床部分，我们将评估200名早产儿和足月儿的呼吸阻力。研究对象将包括正常婴儿、患有BPD和其他呼吸系统疾病的婴儿。我们将研究接受支气管扩张剂、利尿剂、咖啡因等的婴儿，以证明该设备检测这些治疗后呼吸道阻力变化的能力。本申请书是应《新生儿重症监护病房(SBIR[R43])用安全有效的仪器设备》申请的要求而编制的。 与公共卫生相关：极低出生体重儿的支气管肺发育不良(BPD)发病率很高，已成为一个主要的公共卫生问题，每年新增7000至10,000例。目前还没有非侵入性设备来诊断/监测这些婴儿。我们已经开发了这样一种设备(Apd)，它完美地适用于儿童和成人。我们正在提议加强无创、敏感、可靠和廉价的apd在婴儿人群中的使用。这一新设备--新生儿apd将成为新生儿重症监护病房的有用工具。

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.