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

新生儿 APD，一种用于新生儿 ICU 的简单无创诊断/监测设备

• 批准号: 7907279
• 负责人: JAFAR VOSSOUGHI
• 金额: $ 27.13万
• 依托单位: ENGINEERING AND SCIENTIFIC RESEARCH ASSO
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-06-01 至 2012-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7907279
• 关键词: Adult; Airway Resistance; Ambulatory Care Facilities; Back; Birth Weight; Bronchodilator Agents; Bronchopulmonary Dysplasia; Caffeine; Caring; Child; Clinical; Clinical Data; Clinical Engineering; Devices; Diagnosis; Diagnostic; Direct Costs; Diuretics; Effectiveness; Engineering; Extremely Low Birth Weight Infant; Grant; Incidence; Individual; Infant; Lung; Lung diseases; Modification; Monitor; National Heart, Lung, and Blood Institute; Neonatal; Neonatal Intensive Care Units; Newborn Infant; Oral cavity; Patient Care; Patients; Pharmaceutical Preparations; Phase; Population; Premature Infant; Protocols documentation; Public Health; Request for Applications; Research Ethics Committees; Resistance; Respiration Disorders; Small Business Innovation Research Grant; Survival Rate; Time; Transducers; United States National Institutes of Health; University Hospitals; Work; aged; compliance behavior; cost; face mask; follow-up; improved; infant monitoring; instrument; meetings; monitoring device; pressure; public health relevance; pulmonary function; respiratory; response; spelling; tool

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.

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增加，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例新发病例。这些早产儿（出生体重500至1，500 g）长期留在新生儿重症监护室（NICU），并且经常接受各种可能有毒的药物治疗其肺部疾病，没有实际的方法准确确定是否需要这种治疗或监测其有效性。这是因为目前没有可供NICU使用的无创肺部诊断/监测设备。我们开发了一种无创肺部诊断设备，气流扰动设备（APD），可以在不到一分钟的时间内无创、快速、轻松地评估患者的呼吸阻力。该装置体积小、便携，并且可以以非常低的成本生产。APD已大大加强使用NIH NHLBI SBIR赠款，现在在其第二阶段的期限结束。我们已经在2,000多名2至88岁的人身上验证了APD。最近，使用APD，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。结果令人鼓舞，并表明，通过一些设备增强（更灵敏的压力和流量传感器，减少死腔等），APD可以适用于婴儿人群。如果成功，它将是唯一一种可以无创诊断/监测早产儿肺功能的设备。这将满足新生儿重症监护室和门诊诊所的迫切需求，从而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，低死腔，轻松地与面罩一起使用）。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，而无需患者积极合作。提出的工作包括两个部分，工程和临床。工程方面的工作包括修改和增强现有的APD，具有足够的灵敏度，以在20秒内可靠地检测小婴儿口腔压力和流量，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。受试者将包括正常婴儿、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、咖啡因等治疗的婴儿，以证明该设备检测气道阻力变化的能力。本申请是为了响应“RFA-HD-09-017;新生儿重症监护室（SBIR [R43]）使用的安全有效仪器和器械”的申请而编写的。 公共卫生关系：极低出生体重儿中支气管肺发育不良（BPD）的发病率很高，每年有7，000至10，000例新发病例，已成为一个主要的公共卫生问题。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），它完全适合儿童和成人。我们建议加强APD用于婴儿人群，这将是非侵入性的，敏感的，可靠的和廉价的。新设备，新生儿APD将是一个有用的工具，在新生儿重症监护病房。