Diagnostic Monitor to Guide Early Goal-Directed Therapy in Emergency Departments

描述（由申请人提供）：用于指导急诊科早期目标导向治疗的诊断监视器摘要危重患者的死亡率不必要地高，因为通常在急诊科进行诊断需要延长时间（6-7小时），而等待被送往适当的重症监护病房（ICU）进行治疗。我们需要的是一种仪器，它可以立即诊断出这类患者，并提供治疗指南，使急诊科人员能够在到达急诊室后的头6个小时内开始挽救生命的医疗治疗。虽然有几种无创监测仪可以测量心输出量（CO）和各种其他血液动力学参数，但它们由于无法监测足够的参数以量化和纠正生理干扰而受到限制。所提出的开发具有同时获取这些关键参数的能力。由于所有“干扰”因素都是对疾病诊断和患者管理具有重要意义的生理参数，因此建议的监测器被称为紧急诊断监测器（EDM）。建议的电火花加工提供了足够数量的测量（称为“全套”），以确保其中任何一个测量的准确性。这种监测仪是非侵入性的，通过使用肺部作为气体注射（示踪剂浓度）和测量的端口，几乎消除了患者的风险。该方法的初步测试在实验动物身上证明是成功的。然而，对慢性阻塞性肺疾病（COPD）受试者的研究表明，异步通气是导致显著误差的原因。因此，为了使监护仪能够处理广泛的病理，需要额外的心肺测量，以量化异步通气及其对其他参数的影响。因此，主要任务是通过使用双注入方案来解决异步通风问题，这需要测量额外的惰性（示踪）气体。为了使“成套”的概念在经济上可行，气体分析仪必须能够经济地监测13种气体，并且只有高度定量的仪器才能做到这一点。它还必须满足医疗设备的成本限制。医学质谱的一个重大进展是开发了一种专利的压电控制入口阀（由该小组开发）。以此为基础，开发了一种低功率商用医用质谱仪（Solo(R)），该质谱仪在医院环境中显示出高度的可靠性。修改Solo(R)将允许监测校正通风相位所需的额外气体，这是本提案的任务之一。edm的诊断能力通过包括18个生理参数的测量集得到增强。在感染性休克患者中验证其早期目标导向治疗（EGDT）指导是本i期研究的主要重点。危重病人的死亡率是不必要的高，因为在急诊科做出诊断通常需要6-7小时的时间，而等待被送到适当的重症监护病房（ICU）治疗。我们所需要的是一种非侵入性仪器，能够立即诊断出这类患者，并提供治疗指导，使急诊科人员能够在ICU治疗可用之前开始挽救生命的医疗治疗。该项目的目标是开发和测试一种可靠性和全面性的无创仪器，为急救人员提供感染性休克的早期检测和实用指导。

DESCRIPTION (provided by applicant): Diagnostic Monitor to Guide Early Goal-Directed Therapy in Emergency Departments Summary Mortality rates for critically ill patients are unnecessarily high because of the extended time (6-7 hrs) that it usually takes for diagnoses to be rendered in Emergency Departments while waiting to be sent to an appropriate intensive care unit (ICU) for treatment. What is needed is an instrument that can immediately diagnose such patients and provide therapy guidelines that would allow Emergency Department personnel to initiate life-saving medical treatment during the first 6 hours after arrival to Emergency. While there are several noninvasive monitors that measure cardiac output (CO) and various other hemodynamic parameters, they are limited by their inability to monitor sufficient parameters in order to quantify and correct for physiological interferences. The proposed development has the capability to acquire these critical parameters simultaneously. Since all "interfering" elements are physiological parameters that have significance for disease diagnosis and patient management, the proposed monitor is referred to as an Emergency Diagnostic Monitor (EDM). The proposed EDM provides a sufficient number of measurements (referred to as a "complete set") to assure accuracy of any one of them. This monitor is noninvasive, and patient risk is virtually eliminated by using the lung as a port for both injection of gases (in tracer concentrations) and their measurements. Initial tests of the methodology proved successful in experimental animals. However, studies with chronic obstructive pulmonary disease (COPD) subjects revealed that asynchronous ventilation was the cause of significant error. Therefore, in order for the monitor to address a wide range of pathologies, additional cardiopulmonary measurements are needed which allow quantification of asynchronous ventilation and its effects on other parameters. Therefore, a major task is to solve the problem of asynchronous ventilation by use of a dual injection scheme, which requires measurement of additional inert (tracer) gases. In order for the concept of a "complete set" to be economically viable, the gas analyzer must be capable of monitoring thirteen gases economically and with accuracy found in only highly quantitative instruments. It must also meet cost constraints of medical devices. A significant advance in medical mass spectroscopy has been the development of a patented piezo controlled inlet valve (developed by this group). From this, a low power commercial medical mass spectrometer (Solo(R)) was developed which displayed a high degree of reliability in the hospital environment. Modification of Solo(R) will allow monitoring of the additional gases needed to correct for ventilation phasing and is one of the tasks of this proposal. The EDMs diagnostic capability is enhanced by a measurement set that includes a total of 18 physiological parameters. Its validation in septic shock patients for early goal-directed therapy (EGDT) guidance is the main focus of this Phase I. PUBLIC HEALTH RELEVANCE: Diagnostic Monitor to Guide Early Goal-Directed Therapy in Emergency Departments Narrative Mortality rates for critically ill patients are unnecessarily high because of the extended time (6-7 hrs) that it usually takes for diagnoses to be rendered in Emergency Departments while waiting to be sent to an appropriate intensive care unit (ICU) for treatment. What is needed is a noninvasive instrument that can immediately diagnose such patients and provide therapy guides to allow Emergency Department personnel to initiate life-saving medical treatment before ICU treatment is available. The goal of this project is to develop and test a noninvasive instrument with the reliability and comprehensiveness needed to provide earlier detection, of septic shock and practical guidance by Emergency personnel.