Pulse Oximeter for Newborn Screening

用于新生儿筛查的脉搏血氧仪

基本信息

批准号：
8454540
负责人：
Manal Beshay
金额：
$ 32.62万
依托单位：
INTELLIGENT OPTICAL SYSTEMS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-07-05 至 2014-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8454540
关键词：
Address Adult Algorithms Anatomy Anterior Benchmarking Cause of Death Centers for Disease Control and Prevention (U.S.)Cessation of life Clinical Clinical Data Clinical Research Clinical Trials Clinical effectiveness Congenital Abnormality Data Detection Development Devices Distress Effectiveness Engineering Evaluation Event Feedback Goals Government Hand Hospitals Hour Human Resources Infant Infection prevention Lead Left Life Light Measurement Medical center Morbidity - disease rate Morphologic artifacts Movement Neonatal Screening Newborn Infant Nurseries Optics Outcome Oxygen saturation measurement Patients Persons Phase Physical Examination Physiologic pulse Positioning Attribute Procedures Pulse Oximetry Reading Recruitment Activity Research Screening procedure Shapes Signal Transduction Source System Testing Time Training Validation Work clinical practice computerized data processing congenital heart disorder cost cost effectiveness design detector foot improved instrument meetings mortality phase 1 study phase 2 study programs prototype public health relevance safety testing screening sensor time use tool

项目摘要

DESCRIPTION (provided by applicant): Congenital heart diseases (CHD) are the most common serious congenital anomalies and the leading cause of death due to birth defects. Clinical practice relying on physical examination of the newborn before discharge from the nursery often misses newborns with critical CHD (CCHD), which can lead to death or long-term morbidities. Using pulse oximetry (PO) can improve clinical examination by detecting CCHD that would otherwise be missed. In September 2011, DHHS decided to add pulse oximetry screening in the right hand and one foot for CCHD detection to the Recommended Uniform Screening Panel. Hospitals throughout the US are now working expeditiously to implement PO screening programs so that all newborns will have PO screening prior to nursery discharge. However, there is no PO device for newborns and many are concerned about the high false screening rates and cost using current pulse oximeters. The goal of this project is to develop a pulse oximeter for newborn screening (PONS) that has many advantages: 1) simple to use thus reducing training time and cost; 2) much shorter procedure time; 3) better signal quality from multiple sensors; 4) lower cost from lower false positive rate and elimination of disposable sensors; less patient distress. We aim to develop a PONS prototype with multiple sensors for newborn screening. Our PONS device will slip over the infant's hand or foot, and a unique combination of algorithms and sensor placement will provide accurate, reproducible, SpO2 reading in less than two minutes. A single use interior cover of the device will be used to prevent infection, enhance signal acquisition, and reduce the cost of screening. After initial bench top testing, safety and efficacy, the PONS will be evaluated in 5 adults first, then in 5 newborns with co-oximetry validation. We will then conduct a clinical effectiveness study on newborns to benchmark PONS readings against conventional readings with a commercial pulse oximeter. We will recruit 100 newborns from the nursery at Harbor-UCLA Medical Center. All newborns will have pulse oximeter checks by a commercial device and the PONS at 24 hours of life. The primary expected outcome is a reduction of total procedure time with the PONS device. We will also compare the following parameters-SpO2, signal quality, time for signal acquisition, cost, and user feedback. In Phase II of this project, the Phase I clinical will be used to re-engineer th device and conduct a clinical trial evaluating the cost-effectiveness of the PONS for CCHD detection in newborns during Phase II.

描述（由申请人提供）：先天性心脏病（CHD）是最常见的严重先天性异常，也是由于先天缺陷而导致的死亡原因。依靠新生儿进行体格检查的临床实践在出院之前，经常会错过新生儿的关键冠心病（CCHD），这可能导致死亡或长期病毒。使用脉搏血氧饱和度（PO）可以通过检测CCHD来改善临床检查。 2011年9月，DHHS决定在右手中添加脉搏血氧仪筛查，一只脚以CCHD检测到建议的均匀筛选面板。现在，美国各地的医院正在迅速努力实施PO筛查计划，以便所有新生儿都将在托儿所出院之前进行PO筛查。但是，没有用于新生儿的PO设备，许多人担心使用当前的脉搏血氧仪的高假筛查率和成本。该项目的目的是开发具有许多优势的新生儿筛查（PON）的脉搏血氧仪：1）易于使用，从而减少训练时间和成本； 2）步骤时间较短； 3）多个传感器的信号质量更好； 4）较低的假正率和消除一次性传感器的成本较低；耐心的困扰减少。我们旨在开发带有多个新生儿筛选的多个传感器的PON原型。我们的PONS设备将滑过婴儿的手或脚，算法和传感器放置的独特组合将在不到两分钟的时间内提供准确，可重现的SPO2读数。设备的一次使用内部盖将用于防止感染，增强信号获取并降低筛查成本。在初始台式测试，安全性和功效后，将首先在5名成人中评估PON，然后在5个新生儿中进行评估共氧化验证。然后，我们将对新生儿进行一项临床有效性研究，以基准用商业脉搏血氧仪对常规读数进行基准pons读数。我们将从苏联医疗中心的托儿所招募100名新生儿。所有新生儿都将通过商用装置进行脉搏血氧仪检查，并在生命的24小时内进行PON。预期的主要结果是使用PONS设备减少了总过程时间。我们还将比较以下参数SPO2，信号质量，信号获取的时间，成本和用户反馈。在该项目的第二阶段中，I期临床将用于重新工程设备，并进行临床试验，以评估II期新生儿中PON对新生儿中CCHD检测的成本效益。