A new breath monitor for detection of the acute phase response in patients

一种用于检测患者急性期反应的新型呼吸监测仪

• 批准号: 8931372
• 负责人: Daniel E Butz
• 金额: $ 100.51万
• 依托单位: ISOMARK, LLC
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-01 至 2016-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8931372
• 关键词: Acute-Phase Reaction; Adult; Animals; Biological Markers; Breath Tests; Budgets; Carbon Dioxide; Cells; Childhood; Clinical; Clinical Research; Clinical Trials; Critical Illness; Data; Detection; Development; Device Approval; Device Designs; Devices; Disease; Early Diagnosis; Early treatment; Endotoxemia; Engineering; Equipment; Evaluation; Family suidae; Gases; Goals; Government; Health; Hour; Human; Incubators; Infection; Intensive Care; Intensive Care Units; Lead; Legal patent; Length of Stay; Letters; Marketing; Measurement; Mechanical Ventilators; Methods; Monitor; Morbidity - disease rate; Patient Monitoring; Patients; Performance; Phase; Physiological; Research; Sampling; Scanning; Scientist; Sepsis; Spectrum Analysis; Techniques; Technology; Testing; Time; Validation; Work; base; design; graphical user interface; high risk; instrument; meetings; miniaturize; mortality; novel; pediatric patients; point of care; preclinical study; prototype; septic

DESCRIPTION: Infections are a leading cause of mortality in adult and pediatric ICUs. Earlier diagnosis and treatment of infection could significantly reduce patient morbidity and mortality. Unfortunately, current methods of detection cannot routinely detect infection early in the disease course. Isomark has developed a breath-based early detection technology (biomarkers and instruments for detection) that can pinpoint the onset of acute phase response (APR) to infection enabling earlier diagnosis/treatment. Infections in hospitalized patients lengthen hospital stays-a major expense. Isomark's overarching goal for this project is to commercialize its compact breath analyzer and patented method for monitoring breath for changes indicative of the onset of infection. This technology will aid in early detection of infections in high-risk intensive care unit (ICU) patients. Isomark has developed a noninvasive marker for monitoring patients at high risk of developing infections. In preclinical studies, Isomark's technology effectively detected the onset of the APR to infection via breath delta values (BDV) as early as 2 h after endotoxemia onset. In a preliminary clinical study (33 adult and pediatric patients), Isomark's technology detected the onset of APR to infection in 2 patients who acquired infections fully 24 h before doctors suspected infection. Based on these data, Isomark's breath analysis will provide clinicians a new physiological marker of the APR to infection that will aid i earlier diagnosis. In this Fast-Track project, Isomark scientists and engineers will work with strategic partner Picarro Inc. (Picarro; Santa Clara, CA; see Letters of Support) to develop a miniaturized point of care (POC) BDV monitor that easily attaches to existing mechanical ventilator equipment and monitors for changes in breath that indicate the APR to developing infections. In phase I, a team consisting of Isomark staff and engineers at strategic partner Picarro will develop a novel method of cavity enhanced spectroscopy, based on free spectral resonance of the gas cell, for BDV measurement in human breath that is miniaturizable and less expensive that current technologies. Isomark will also produce a prototype device and graphical user interface. In phase II, Isomark will miniaturize the device and integrate the graphical user interface. Isomark will validate that the product performs to expected specifications in the clinicl setting by performing an animal study of sepsis in mechanically ventilated swine. Finally, Isomark will produce a prototype device and device design file to facilitate regulatory approval of the device. The successful completion of this project will result in a the Isomark CanaryPOC BDV monitor capable of real- time detection of the acute phase response to infection in mechanically ventilated patients. The Phase I project will demonstrate proof of principal for this new measurement technique. In phase II, Isomark will construct the final prototype device and validate that it functions as espected. In phase III, Isomark will perform clinical trials for FDA clearance of the new incubator for early detection of sepsis, and then begin marketing the device.

描述：感染是成人和儿科icu死亡的主要原因。早期诊断和治疗感染可显著降低患者的发病率和死亡率。不幸的是，目前的检测方法不能在病程早期常规检测感染。Isomark开发了一种基于呼吸的早期检测技术（生物标志物和检测仪器），可以精确定位感染的急性期反应（APR）的开始，从而实现早期诊断/治疗。住院病人的感染延长了住院时间——这是一项主要开支。Isomark在该项目的总体目标是将其紧凑型呼吸分析仪和用于监测呼吸变化的专利方法商业化，以指示感染的发生。这项技术将有助于早期发现高危重症监护病房（ICU）患者的感染。Isomark开发了一种无创标志物，用于监测高风险感染患者。在临床前研究中，Isomark的技术通过呼吸δ值（BDV）早在内毒素血症发作后2小时就能有效地检测到APR对感染的发作。在一项初步临床研究（33名成人和儿童患者）中，Isomark的技术在医生怀疑感染前24小时检测到2名获得感染的患者的APR感染发病。基于这些数据，Isomark的呼吸分析将为临床医生提供一种新的APR感染生理标志物，有助于早期诊断。在这个快速通道项目中，Isomark的科学家和工程师将与战略合作伙伴Picarro公司（Picarro; Santa Clara， CA；见支持信）合作，开发一种小型化的护理点（POC） BDV监测仪，该监测仪可以轻松地连接到现有的机械呼吸设备上，并监测呼吸变化，表明APR发生感染。在第一阶段，一个由Isomark员工和战略合作伙伴Picarro的工程师组成的团队将开发一种新的腔增强光谱方法，基于气体细胞的自由光谱共振，用于测量人类呼吸中的BDV，这种方法比现有技术小型化且更便宜。Isomark还将生产一个原型设备和图形用户界面。在第二阶段，Isomark将使设备小型化并集成图形用户界面。Isomark将通过对机械通气猪进行脓毒症动物研究，验证该产品在临床环境中是否符合预期规格。最后，Isomark将生产一个原型设备和设备设计文件，以促进监管部门的批准