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™)

• 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
• 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

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.

项目总结/摘要 所提出的努力解决了肺水肿（PE）早期检测的未满足需求。PE是一种心血管疾病 是急性呼吸窘迫综合征和急性心力衰竭的根本原因，预计影响超过 到2030年，美国人口将达到800万。肺栓塞是由异常高的毛细血管渗漏到肺泡腔中引起的， 血管外肺积水（EVLW）。它可能危及生命，但有效的治疗可以挽救 如果早期发现，患者将免受这种肺液体失衡的有害后果。然而，延误和漏诊 在PE中很常见，因为在医院外无法获得有效的工具。超声心动图和胸部检查等工具 最好在医院环境中对急性心力衰竭患者进行放射摄影。这突出表明， 简单、廉价、无创的检测方法，可用于常规筛查PE风险人群，包括 患有血管或血液疾病的患者或经历过造血干细胞移植（HSCT）的患者。 在拟议的研究中，我们打算展示一种技术和方法， 呼出气体作为探针，以评估是否存在过量EVLW和过量EVLW。有迹象表明， 检测两种或更多种气体分子透过血液-空气屏障进入呼出气的速率可以 与血管外肺水量有很强的联系。在这项SBIR I期研究中，Exhalix将与 辛辛那提大学工程学院进行模拟气体交换实验室实验，以证明 该技术用于痕量水检测的优点。通过与新墨西哥州大学商学院合作， 我们打算进行动物研究，其中雄性Sprague-Dawley大鼠的离体肺将用于 评估在刺激PE条件下检测EVLW的可行性。我们预计这些研究将持续12年， 预计可行性论证的成功将导致第二阶段的原型开发工作， 临床环境中的人体研究。