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

描述（由申请方提供）：拟定研究的最终目的是开发一种可靠的床旁试验，以检测胃内容物的肺吸入。这样的测试是特别重要的危重病，机械通气病人接受管饲。虽然在这些个体中偶尔会发生明显的大容量吸入，但胃内容物的微吸入更为常见。这些微吸入通常在临床上是无声的，直到它们累积导致肺部问题（如化学性肺炎或可能危及生命的吸入性肺炎）。目前，尚无可靠的吸入性床边试验。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引器。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。我们的研究小组已经开发出一种高度敏感和特异性的实验室测定主要胃酶，胃蛋白酶，作为胃内容物吸入肺的代理。该测试已在研究环境中有效地用于测试500多名机械通气患者的误吸。虽然我们的实验室检测提供了准确和有用的结果，但它需要大约24小时才能完成。拟议的研究将试图在5分钟内完善我们的实验室检测，以便在床边使用。该试验将基于生物化学合作者在拟定研究中开发的新技术（称为分子钳技术）。新的基于抗体的传感器设计允许快速和灵敏地检测目标蛋白质，其步骤明显少于相同蛋白质的实验室测定所需的步骤。共有2，200份人气管支气管分泌物等分试样可用于该项目，并将用于在床旁检测和参考实验室检测之间进行比较时确定灵敏度、特异性和重现性指标。公共卫生相关性：该研究的目的是开发一种床旁测定法，以检测胃内容物的肺部微吸入。需要进行这样的测试，以区分频繁和不频繁的吸引器，从而可以相应地计划干预措施。共有2，200份人气管支气管分泌物等分试样可用于该项目，并将用于在床旁检测和参考实验室检测之间进行比较时确定灵敏度、特异性和重现性指标。

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.