Pulse Oximeter Innovation to Measure Pulsus Paradoxus and Respiratory Disease Severity

脉搏血氧仪创新测量奇异脉和呼吸系统疾病严重程度

• 批准号: 9046119
• 负责人: DONALD Hayes ARNOLD
• 金额: $ 15万
• 依托单位: KESTREL LABS, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-06-07 至 2018-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9046119
• 关键词: Acute; Admission activity; Adult; Aftercare; Age; Agreement; Algorithms; Applications Grants; Area Under Curve; Arterial Lines; Asthma; Blood Pressure; Breathing; Bronchiolitis; Cardiac Tamponade; Child; Childhood; Chronic; Chronic Obstructive Airway Disease; Clinical; Communities; Data; Data Collection; Data Set; Decision Making; Development; Devices; Diagnosis; Disease; Emergency department visit; Environment; Evaluation; Goals; Government; Grant; Guidelines; Health Care Costs; Healthcare; Healthcare Systems; Hospitalization; Hospitals; Indwelling Catheter; Left; Light; Lung diseases; Manuals; Marketing; Measurement; Measures; Medical; Methods; Modeling; Monitor; Output; Patient Care; Patient Discharge; Patients; Performance; Persons; Phase; Physiologic pulse; Pneumothorax; Principal Investigator; Process; Pulse Oximetry; Recommendation; Relapse; Research; Research Methodology; Respiration Disorders; Sales; Sampling; Savings; Severities; Severity of illness; Small Business Innovation Research Grant; Stethoscopes; Stream; Stroke Volume; Techniques; Time; Tissues; Trauma; Triage; United States National Institutes of Health; Validation; Variant; Ventricular; Work; absorption; airway obstruction; asthmatic patient; base; design; expiration; improved; innovation; non-compliance; pressure; prevent; product development; public health relevance; respiratory; success; technology development; temporal measurement; tool; treatment response; trend; trend analysis

 DESCRIPTION (provided by applicant): Asthma is the most common chronic childhood disease and the most frequent reason for hospitalization of children. It is also the most common chronic respiratory disorder in adults. It results in over 1.7 million emergency department visits and about 450,000 hospitalizations annually in the U.S. alone. The National Institutes of Health (NIH) expert guidelines recommend the measurement of Pulsus Paradoxus (the variation in systolic blood pressure that occurs with inspiration and expiration) as a clinical standard for determination of acute asthma exacerbation severity and to help guide appropriate treatment and hospitalization decisions for these patients. Currently, however, there are no invasive or noninvasive monitors for the automated measurement of Pulsus Paradoxus. Worse still the only clinically-available noninvasive technique is performed using a stethoscope and a blood pressure cuff and is so time consuming and difficult to perform in a clinical environment that compliance with this NIH recommendation is estimated at less than 1%. Given the well-recognized clinical value of Pulsus Paradoxus, and the enormous financial burden of acute asthma attacks on the healthcare system, it is clear that an automated, easy-to-use, noninvasive monitor for Pulsus Paradoxus would improve patient care and reduce unnecessary hospital re- admissions, increase compliance with NIH recommendations, and decrease healthcare costs associated with acute asthma. This SBIR Grant proposal is designed to determine whether Pulsus Paradoxus information is contained in the raw pulse oximetry data, and whether these data can be extracted and processed to provide an accurate, noninvasive, real-time measurement of Pulsus Paradoxus. What sets this grant up for success is the combination of expertise provide by having two principal investigators. One is a clinical expert in asthma diagnosis and treatment, including prior work studying current methodologies and research concepts for the measurement and use of Pulsus Paradoxus, and the other has over 30 years in the field of pulse oximetry technology and product development. Once this proof of concept study is successfully completed, Phase II work would include integrating this measurement into an existing pulse oximeter to provide easy-to-use, real-time measurement of this crucial parameter and to demonstrate that this capability could increase compliance with NIH guidelines from the current <1% to over 80% in the clinical environment.

 描述(申请人提供)：哮喘是儿童最常见的慢性疾病，也是儿童住院的最常见原因。这也是成人最常见的慢性呼吸系统疾病。仅在美国，每年就有超过170万人去急诊科就诊，约45万人住院治疗。美国国立卫生研究院(NIH)的专家指南建议，测量脉搏反常(随着吸气和呼气而发生的收缩压变化)作为确定哮喘急性加重严重程度的临床标准，并帮助指导这些患者的适当治疗和住院决定。然而，目前还没有侵入性或非侵入性的监测仪来自动测量脉冲反常现象。更糟糕的是，临床上唯一可用的非侵入性技术是使用听诊器和血压袖带进行的，而且在临床环境中执行起来非常耗时和困难，因此符合NIH的建议估计不到1%。鉴于Pulsus paroxus公认的临床价值，以及急性哮喘发作对医疗系统造成的巨大经济负担，显然，对Pulsus Paroxus进行自动化、易于使用、非侵入性的监测将改善患者护理，减少不必要的再次住院，提高对NIH建议的遵从性，并降低与急性哮喘相关的医疗成本。SBIR GRANT建议旨在确定原始脉搏血氧仪数据中是否包含脉搏血氧饱和度信息，以及这些数据是否可以被提取和处理以提供准确、非侵入性、实时的脉搏血氧饱和度测量。这笔赠款之所以成功，是因为有两名首席调查人员提供的专业知识的结合。其中一位是 一个是哮喘诊断和治疗，包括研究目前测量和使用Pulsus paroxus的方法和研究概念的先前工作，另一个是在脉搏血氧仪技术和产品开发领域的30多年的工作。一旦这项概念验证研究成功完成，第二阶段的工作将包括将这一测量集成到现有的脉搏血氧仪中，以提供对这一关键参数的易于使用的实时测量，并证明这种能力可以将临床环境中对NIH指南的遵从性从当前的1%提高到80%以上。

项目成果

Prediction of acute asthma exacerbation severity and interrater reliability of manual pulsus paradoxus measurement.

手动奇脉测量的急性哮喘发作严重程度和受试者间可靠性的预测。

• DOI: 10.1016/j.anai.2019.03.027
• 发表时间: 2019
• 期刊: Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology
• 作者: Arnold,DonaldH;Vukovic,AdamA;Arnold,CosbyG;Penrod,Cody;Pologe,JonasA
• 通讯作者: Pologe,JonasA