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

描述（由申请人提供）：在急诊科指导早期目标导向治疗的诊断监测器摘要危重患者的死亡率不必要地高，因为在急诊科等待被送往适当的重症监护室（ICU）治疗时，通常需要延长诊断时间（6-7小时）。需要的是一种能够立即诊断此类患者并提供治疗指南的仪器，该治疗指南将允许急诊科人员在到达急诊室后的前6个小时内开始挽救生命的医疗治疗。虽然存在测量心输出量（CO）和各种其他血液动力学参数的若干无创监测器，但是它们受限于它们不能监测足够的参数以便量化和校正生理干扰。拟议的开发有能力同时获得这些关键参数。由于所有“干扰”元素都是对疾病诊断和患者管理具有重要意义的生理参数，因此申报监护仪被称为紧急诊断监护仪（EDM）。拟议的EDM提供了足够数量的测量（称为“全套”），以确保其中任何一个的准确性。该监护仪是非侵入性的，通过使用肺作为气体注射（示踪剂浓度）及其测量的端口，几乎消除了患者风险。该方法的初步测试在实验动物中证明是成功的。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错误的原因。因此，为了使监护仪能够处理各种病理，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，一个主要的任务是通过使用双注入方案来解决异步通风的问题，这需要测量额外的惰性（示踪）气体。为了使“全套”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，并且只有在高度定量的仪器中才能找到准确度。它还必须满足医疗设备的成本限制。医疗质谱的一个重大进步是专利压电控制进气阀的开发（由该小组开发）。由此，开发了低功率商用医用质谱仪（Solo（R）），其在医院环境中显示出高度的可靠性。Solo（R）的修改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的诊断能力通过测量集得到增强，该测量集包括总共18个生理参数。其在感染性休克患者中的早期目标导向治疗（EGDT）指导的验证是本I期的主要焦点。公共卫生相关性：在急诊科指导早期目标导向治疗的诊断监测重症患者的叙述死亡率不必要地高，因为在急诊科等待被送往适当的重症监护室（ICU）进行治疗时，通常需要延长诊断时间（6-7小时）。我们需要的是一种非侵入性的仪器，可以立即诊断这些患者，并提供治疗指南，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。该项目的目标是开发和测试一种非侵入性仪器，其可靠性和全面性需要提供早期检测，脓毒性休克和急救人员的实际指导。

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.