Development of a 'Nurse-Friendly' Bedside Test for Aspiration

描述（由申请人提供）：拟议研究的最终目的是开发一种可靠的床边试验来检测肺吸进胃内容物。这样的测试对危重病人、接受管饲的机械通气病人尤其重要。虽然这些人偶尔会出现明显的大容量胃内容物的胃内吐，但反流胃内容物的微量胃内吐更为常见。这些微小的抱负在临床上通常是无声的，直到它们累积起来导致肺部问题（如化学性肺炎或可能危及生命的吸入性肺炎）。目前，还没有可靠的床边试验。不幸的是，没有这样的测试，护士无法区分频繁和不频繁的无声吸气。这反过来又阻碍了他们及时干预以防止患者预后不良的能力。我们的研究团队开发了一种高灵敏度和特异性的胃酶胃蛋白酶实验室检测方法，胃蛋白酶是胃内容物吸入肺部的代理。该测试已在一个研究环境中有效地用于测试500多名机械通气患者的误吸。虽然我们的实验室化验提供准确和有用的结果，但需要大约24小时才能完成。拟议的研究将尝试改进我们的实验室检测方法，以便在5分钟内在床边使用。该分析将基于新技术（称为分子钳技术），由生物化学合作者在拟议的研究中开发。新的基于抗体的传感器设计允许快速和敏感地检测目标蛋白质，比实验室检测相同蛋白质所需的步骤少得多。该项目共有2,200份人气管支气管分泌物，将用于在床边测定法和参考实验室测定法之间进行比较时确定敏感性、特异性和可重复性。公共卫生相关性：该研究的目的是开发一种床边检测方法来检测胃内容物的肺微抱负。需要这样的测试来区分频繁和不频繁的吸痰者，以便可以相应地计划干预措施。该项目共有2,200份人气管支气管分泌物，将用于在床边测定法和参考实验室测定法之间进行比较时确定敏感性、特异性和可重复性。

DESCRIPTION (provided by applicant): The ultimate aim of the proposed study is to develop a reliable bedside test to detect pulmonary aspiration of gastric contents. Such a test is of especial importance in critically ill, mechanically ventilated patients receiving tube feedings. While obvious large-volume aspirations occasionally occur in these individuals, micro-aspirations of regurgitated gastric contents are far more common. These micro-aspirations are usually clinically silent until they cumulatively lead to pulmonary problems (such as chemical pneumonitis or potentially life-threatening aspiration pneumonia). At present, there is no reliable bedside test for aspiration. Unfortunately, without such a test, nurses are unable to distinguish between frequent and infrequent silent aspirators. This, in turn, impedes their ability to intervene in a timely fashion to prevent poor patient outcomes. Our research team has developed a highly sensitive and specific laboratory assay for the major gastric enzyme, pepsin, which serves as a proxy for the aspiration of gastric contents into the lung. The test has been used effectively in a research setting to test for aspiration in over 500 mechanically ventilated patients. Although our laboratory assay provides accurate and useful results, it takes about 24 hours to perform. The proposed study will attempt to refine our laboratory assay for use at the bedside within a 5 minute period. The assay will be based on new technology (referred to as molecular pincer technology), developed by the biochemistry collaborators on the proposed study. The new antibody-based sensor design allows rapid and sensitive detection of target proteins with significantly fewer steps than required for laboratory assays of the same proteins. A total of 2,200 aliquots of human tracheobronchial secretions are available for the project and will be used to determine measures of sensitivity, specificity, and reproducibility when comparisons are made between the bedside assay and the reference laboratory assay. Public Health Relevance: The study's aim is to develop a bedside assay to detect pulmonary micro-aspirations of gastric contents. Such a test is needed to differentiate between frequent and infrequent aspirators so that interventions can be planned accordingly. A total of 2,200 aliquots of human tracheobronchial secretions are available for the project and will be used to determine measures of sensitivity, specificity, and reproducibility when comparisons are made between the bedside assay and the reference laboratory assay.