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: 8077385
• 负责人: JAFAR VOSSOUGHI
• 金额: $ 25.79万
• 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 2014-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8077385
• 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; Institutional Review Boards; Lung; Lung diseases; Methods; 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; 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）：由于技术的进步和患者护理的改善，出生体重（ELBW）婴儿的生存率大大增加，导致支气管肺发育不良（BPD）的患者数量显着增加。 BPD已成为一个重大的公共卫生问题，每年发生7,000至10,000例新病例。这些早产儿（500至1,500 g出生体重）长期保留在新生儿重症监护病房（NICUS），并且经常接受各种潜在有毒药物来治疗其肺部疾病它的有效性。这是因为当前，没有可用于使用NICU的非侵入性肺诊断/监测设备。我们已经开发了一种非侵入性的肺诊断装置，气流扰动装置（APD），该装置可以在不到一分钟的时间内评估非侵入性，快速且毫不费力地评估患者的呼吸阻力。该设备很小，便携式，可以以非常低的成本生产。使用NIH NHLBI SBIR赠款，APD已在其II期术语结束时大大增强。我们已经对2至88岁的2,000多名个人验证了APD。最近，使用APD，我们探索了乔治敦大学医院（IRB批准的方案）评估早产和全学期婴儿呼吸抗药性的可能性。结果令人鼓舞，并表明，通过一些设备增强（更敏感的压力和流动传感器，减少的死空间等），APD可以适应婴儿种群的使用。如果成功，它将是唯一可以非侵入性诊断/监测早产儿的肺功能的装置。这将满足NICU和门诊诊所的关键需求，从而改善护理和更多合理地使用潜在有毒药物。新的增强设备“新生儿APD”将满足用于新生儿使用设备的严格要求（高灵敏度，低死亡空间，毫不费力地使用面罩）。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，而无需主动患者合作。拟议的工作包括工程和临床的两个部分。工作的工程方面包括对现有APD的修改和增强，具有足够的灵敏度，可以在20秒内可靠地检测出小婴儿的口服和流动，从而减少了死亡空间。在临床部分，我们将评估200个早产儿和全学期婴儿的呼吸阻力。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，咖啡因等的婴儿，以证明该设备对响应这些疗法的检测气道耐药性变化的能力。该申请是根据要求“ RFA-HD-09-017；安全有效的工具和设备用于新生儿重症监护病房（SBIR [R43]）的要求的，准备了此申请”。 公共卫生相关性：在极低的出生体重婴儿中，支气管肺发育不良（BPD）的发生率很高，这已成为一个重大的公共卫生问题，每年发生7,000至10,000例新病例。当前没有无创设备来诊断/监测这些婴儿。我们已经开发了这样的设备（APD），可完美地适合儿童和成人。我们建议增强APD以供婴儿种群中使用，这将是无创，敏感，可靠和便宜的。新设备Neonatal APD将是新生儿重症监护病房中的有用工具。