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

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在疾病过程的早期常规检测感染。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），从而实现早期诊断/治疗。住院患者的感染延长了住院时间-这是一项主要的费用。Isomark在该项目中的首要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风险重症监护病房（ICU）患者的感染。Isomark开发了一种非侵入性标记物，用于监测感染高危患者。在临床前研究中，Isomark的技术早在内毒素血症发作后2小时就通过呼吸δ值（BDV）有效地检测到感染的APR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2名患者中检测到了APR感染的发生，这些患者在医生怀疑感染前24小时获得了感染。基于这些数据，Isomark的呼吸分析将为临床医生提供一种新的感染APR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 Inc.（皮卡罗;加利福尼亚州圣克拉拉;参见支持信）来开发小型化的护理点（POC）BDV监测器，其容易地附接到现有的机械呼吸机设备并且监测指示APR发展为感染的呼吸变化。在第一阶段，由战略合作伙伴Picarro的Isomark员工和工程师组成的团队将开发一种基于气室自由光谱共振的腔增强光谱学新方法，用于人体呼吸中的BDV测量，该方法可实现且比当前技术便宜。Isomark还将制作一个原型设备和图形用户界面。在第二阶段，Isomark将对设备进行数字化，并集成图形用户界面。Isomark将通过在机械通气猪中进行脓毒症动物研究，确认产品在临床环境中的性能符合预期质量标准。最后，Isomark将制作一个原型设备和设备设计文件，以便于监管部门批准 设备.该项目的成功完成将使Isomark CanaryPOC BDV监测仪能够真实的实时检测机械通气患者对感染的急性期反应。第一阶段项目将证明这种新测量技术的原理。在第二阶段，Isomark将构建最终的原型设备，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对用于早期检测败血症的新型培养箱的批准，然后开始销售该设备。

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.