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

诊断监测仪指导急诊科早期目标导向治疗

• 批准号: 7747733
• 负责人: Justin S. Clark
• 金额: $ 10.59万
• 依托单位: MEDICAL PHYSICS, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-15 至 2011-03-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7747733
• 关键词: Accident and Emergency department; Address; Alveolar; Animals; Biological Neural Networks; Blood Vessels; Blood Volume; Carbon Dioxide; Cardiac Output; Cardiopulmonary; Catheters; Central venous pressure; Chronic; Chronic Obstructive Airway Disease; Computer software; Congestive; Critical Illness; Data; Dependence; Development; Diagnosis; Diagnostic; Early Diagnosis; Early treatment; Elements; Emergency Situation; Environment; Environmental air flow; Extravascular Lung Water; Functional Residual Capacity; Functional disorder; Gases; Goals; Guidelines; Heart; Hemoglobin; Hospitals; Hour; Human Resources; Infection; Injection of therapeutic agent; Intensive Care Units; Legal patent; Life; Lung; Mass Spectrum Analysis; Measurement; Measures; Medical; Medical Device; Methodology; Methods; Modification; Monitor; Network-based; Oxygen; Pathology; Patients; Phase; Physiological; Pilot Projects; Problem Solving; Production; Risk; Rivers; Scheme; Septic Shock; Shunt Device; Staging; Stroke Volume; Testing; Tidal Volume; Time; Tracer; Validation; Venous; Water; artery occlusion; base; capillary; cost; disease diagnosis; early onset; gas analyzer; hemodynamics; instrument; mass spectrometer; meetings; mortality; pressure; public health relevance; septic; success; uptake

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.

描述（由申请人提供）：指导急诊科早期目标导向治疗的诊断监测器 摘要 由于诊断通常需要很长的时间（6-7 小时），危重患者的死亡率不必要地高。急诊科正在等待被送往适当的重症监护室 (ICU) 接受治疗。我们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，使急诊科人员能够在到达急诊室后的前 6 小时内启动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) 和各种其他血流动力学参数，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。拟议的开发能够同时获取这些关键参数。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，因此所提出的监测器被称为紧急诊断监测器（EDM）。所提出的 EDM 提供了足够数量的测量（称为“完整集”）以确保其中任何一个的准确性。该监测仪是非侵入性的，通过使用肺部作为气体注入（示踪剂浓度）和测量的端口，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，对慢性阻塞性肺病 (COPD) 受试者的研究表明，异步通气是造成重大误差的原因。因此，为了使监测仪能够解决广泛的病理问题，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，一个主要任务是通过使用双注射方案来解决异步通气问题，这需要测量额外的惰性（示踪）气体。为了使“全套”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，并且具有只有高度定量仪器才能达到的精度。它还必须满足医疗设备的成本限制。医学质谱领域的一项重大进步是开发了获得专利的压电控制入口阀（由该小组开发）。由此开发了一种低功耗商用医用质谱仪 (Solo(R))，它在医院环境中表现出高度的可靠性。对 Solo(R) 的修改将允许监测纠正通风相位所需的额外气体，这是该提案的任务之一。 EDM 的诊断能力通过包含总共 18 个生理参数的测量集得到增强。其在感染性休克患者中验证早期目标导向治疗 (EGDT) 指导是第一阶段的主要焦点。 公共健康相关性：诊断监测指导急诊科的早期目标导向治疗 危重患者的叙述死亡率是不必要的之所以高，是因为在等待被送往适当的重症监护室 (ICU) 进行治疗时，急诊科通常需要很长的时间（6-7 小时）进行诊断。 治疗。我们需要的是一种无创仪器，可以立即诊断此类患者并提供治疗指南，以便急诊科人员在 ICU 治疗之前启动挽救生命的医疗治疗。该项目的目标是开发和测试一种非侵入性仪器，该仪器具有提供感染性休克早期检测和急救人员实际指导所需的可靠性和全面性。