Dynamic Breath Gas Sensor (DBGS™) for Detection of Pulmonary Edema

用于检测肺水肿的动态呼吸气体传感器 (DBGS™)

基本信息

批准号：
9901870
负责人：
Reza Shekarriz
金额：
$ 29.83万
依托单位：
EXHALIX, LLC
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-02-17 至 2022-01-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9901870
关键词：
Acetone Acute Address Adult Respiratory Distress Syndrome Affect Alveolar American Animals Auscultation Behavior Blood capillaries Blood-Air Barrier Breath Tests Cardiovascular Diseases Cardiovascular Physiology Characteristics Clinical Clinical Research Cohort Studies Competence Detection Development Devices Diagnosis Diagnostic Procedure Diagnostic radiologic examination Diffuse Disease Early Diagnosis Echocardiography Electrocardiogram Engineering Environment Equipment Evaluation Exhalation Extravasation Extravascular Lung Water Failure Floods Formaldehyde Gases General Practitioners Goals Government Heart failure Hematological Disease Hematopoietic Stem Cell Transplantation Home environment Hospitals Human Human Resources Hydrogen Sulfide Hypoxemia Impairment Interobserver Variability Investigation Ions Isoprene Laboratories Laboratory Animals Lead Legal patent Life Link Liquid substance Lung Mass Spectrum Analysis Measurement Measures Medical Device Medicine Membrane Methodology Methods Monitor Natriuretic Peptides New Mexico Non-Invasive Cancer Detection Patients Performance Phase Phase I Clinical Trials Physiological Price Protocols documentation Pulmonary Edema Reaction Time Research Research Personnel Resolution Resources Risk Semiconductors Severities Small Business Innovation Research Grant Solubility Sprague-Dawley Rats Stethoscopes Techniques Technology Testing Thermodilution Thoracic Radiography Time Tube Ultrasonography Universities Vascular Diseases Vascular Permeabilities Water Work clinical application college commercialization cost diagnostic accuracy effective therapy hydrophilicity innovation laboratory experiment lipophilicity male medical schools metal oxide phase 1 study portability product development professor prototype pulmonary vascular permeability routine screening screening sensor success temporal measurement tool user-friendly

项目摘要

Project Summary/Abstract The proposed effort addresses an unmet need for early detection of pulmonary edema (PE). PE is a cardiovascular disorder and is the underlying cause of acute respiratory distress syndrome and acute heart failure, projected to affect more than 8 million Americans by 2030. PE is caused by abnormally high capillary leakage into the alveolar cavities leading to accumulation of extravascular lung water (EVLW). It can be life-threatening, but effective therapy is available to save patients from harmful consequences of this lung fluid imbalance if detected early. However, delays and missed diagnosis are common in PE due to unavailability of effective tools outside of hospitals. Tools such as echocardiography and chest radiography are best performed in patients with acute heart failure in the hospital setting. This highlights the need for a simple, inexpensive, noninvasive detection method that can be used to routinely screen those at risk for PE, including patients with vascular or blood disorders or patients having undergone hematopoietic stem cell transplantation (HSCT). In the proposed study, we intend to demonstrate a technology and methodology that will enable the use of endogenous exhaled gases as probes to assess presence and amount of excessive EVLW. There are indications that simultaneous detection of the rate at which two or more gas molecules permeate the blood-air barrier into the exhaled breath can provide a strong link to the amount of extravascular lung water. In this SBIR Phase I study, Exhalix will collaborate with the University of Cincinnati College of Engineering to perform simulated gas exchange laboratory experiments to demonstrate the merits of this technique for detection of trace amount of water. By teaming with the University of New Mexico School of Medicine, we intend to perform animal studies in which isolated lungs from male Sprague-Dawley rats will be used to evaluate feasibility in detection of EVLW under stimulated PE conditions. We anticipate that these studies will last 12 months and success in feasibility demonstration is expected to lead to a Phase II effort for development of prototypes for human studies in clinical environments.

项目摘要/摘要提出的努力解决了早期检测肺水肿（PE）的未满足的需求。 PE是心血管疾病并且是急性呼吸窘迫综合征和急性心力衰竭的根本原因，预计会影响超过到2030年，有800万美国人。PE是由异常高的毛细血管泄漏到肺泡腔导致的血管外肺水（EVLW）的积累。这可能是威胁生命的，但是有效的疗法可以节省如果早期检测到这种肺液不平衡的有害后果患者。但是，延迟和错过的诊断由于无法在医院之外使用有效的工具，因此在体育中很常见。超声心动图和胸部等工具在医院环境中急性心力衰竭的患者中，射线照相表现最好。这突出了需要简单，廉价，无创检测方法，可用于常规筛选有PE风险的人，包括血管或血液疾病或患有造血干细胞移植（HSCT）的患者。在拟议的研究中，我们打算展示一种技术和方法，该技术将能够使用内源性呼出气体作为评估过度EVLW的存在和数量的探针。有迹象表明同时检测两个或多个气体分子渗透到呼出的呼吸的速率与血管外肺水的量提供了牢固的联系。在SBIR I阶段研究中，Exhalix将与辛辛那提大学工程学院进行模拟的天然气交换实验室实验以证明该技术检测痕量水的优点。通过与新墨西哥大学的学校合作在医学上，我们打算进行动物研究，其中雄性Sprague-Dawley大鼠孤立的肺部将用于评估在受刺激的PE条件下检测EVLW的可行性。我们预计这些研究将持续12 预计几个月和可行性证明的成功将导致II期为开发原型的努力人类研究在临床环境中。