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

用于检测患者急性期反应的新型呼吸监测器

• 批准号: 8713848
• 负责人: Daniel E Butz
• 金额: $ 22.41万
• 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 2014-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8713848
• 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; 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; Simulate; Spectrum Analysis; Techniques; Technology; Testing; Time; Validation; Work; base; design; graphical user interface; high risk; instrument; meetings; miniaturize; mortality; novel; point of care; preclinical study; prototype; public health relevance; 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。感染的早期诊断和治疗可以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常规地在病程早期发现感染。Isomark已经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)，可以准确地确定对感染的急性阶段反应(APR)的开始，从而能够更早地进行诊断/治疗。住院患者的感染延长了住院时间--这是一项主要费用。Isomark这个项目的首要目标是将其紧凑型呼吸分析仪和监测呼吸变化以指示感染开始的专利方法商业化。这项技术将有助于及早发现高危重症监护病房(ICU)患者的感染。Isomark已经开发出一种非侵入性标记，用于监测有高感染风险的患者。在临床前研究中，Isomark的技术最早在内毒素血症开始后2小时就通过呼吸增量值(BDV)有效地检测到APR对感染的开始。在一项初步的临床研究中(33名成人和儿童患者)，Isomark的技术检测到2名患者在医生怀疑感染之前完全24小时获得感染后出现APR。基于这些数据，Isomark的呼气分析将为临床医生提供一个新的APR对感染的生理标记物，这将有助于早期诊断。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 Inc.(Picarro；Santa Clara，CA；参见Letters of Support)合作，开发一种微型护理点(POC)BDV监护仪，该监护仪可以轻松连接到现有的机械呼吸机设备上，并监测呼吸的变化，以指示正在发生的感染的APR。在第一阶段，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，基于气室的自由光谱共振，用于测量人体呼气中的BDV，该方法可微型化，且成本低于当前技术。Isomark还将生产一款原型设备和图形用户界面。在第二阶段，Isomark将使设备微型化并集成图形用户界面。Isommark将通过对机械通风猪的脓毒症进行动物研究，验证该产品在临床环境中的性能达到预期的规格。最后，Isomark将生成原型设备和设备设计文件，以便于监管部门批准 这个装置。该项目的成功完成将使Isomark CanaryPOC BDV监测仪能够实时检测机械通气患者对感染的急性期反应。第一阶段项目将展示这一新测量技术的原理证明。在第二阶段，Isomark将建造最终的原型设备，并验证其功能是否符合预期。在第三阶段，Isomark将进行临床试验，以获得FDA批准的新保温箱的早期检测脓毒症，然后开始销售该设备。