An Integrated Catheter Dressing for Early Detection of Catheter-related Bloodstream Infections

用于早期检测导管相关血流感染的集成导管敷料

• 批准号: 10647072
• 负责人: Hatice Ceylan Koydemir
• 金额: $ 17.5万
• 依托单位: TEXAS A&M UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10647072
• 关键词: Address; Adherence; Affect; Animal Model; Animals; Antibiotic Therapy; Antibiotics; Bacteremia; Bacteria; Bacterial Antibiotic Resistance; Bacterial Infections; Biological Assay; Biosensor; Catheter-related bloodstream infection; Catheters; Central Venous Catheterization; Chemicals; Classification; Clinical; Collaborations; Custom; Data; Data Analyses; Detection; Development; Devices; Early Diagnosis; Early treatment; Electronics; Equipment; Escherichia coli; Excision; Exploratory/Developmental Grant; Foundations; Goals; Growth; Guidelines; Health Care Costs; Hospitalization; Human; Infection; Knowledge; Life; Machine Learning; Measures; Methods; Microfabrication; Monitor; Morbidity - disease rate; National Institute of General Medical Sciences; Nature; Outcome; Patients; Performance; Persons; Public Health; Quality of life; Research; Resources; Science; Sepsis; Signal Transduction; Site; Skin; Sterile coverings; Study models; Systems Development; Testing; Texas; Time; United States National Institutes of Health; Universities; Veterinary Medicine; Wound Infection; antimicrobial; clinical practice; college; cost; data acquisition; data communication; design; diagnostic technologies; dietary restriction; experimental study; flexibility; handheld mobile device; improved; infection risk; light weight; microorganism; migration; mortality; point of care; point-of-care diagnostics; portability; pre-clinical; prototype; real time monitoring; response; sensor; skills; skin microbiota; technology development; technology research and development; wireless; wireless transmission

PROJECT SUMMARY/ABSTRACT Catheter-related bloodstream infection (CRBSI), also called catheter-related sepsis, is one of the most frequent, lethal, and costly complications of central venous catheterization. CRBSI affects hundreds of millions of people worldwide; in the U.S. alone, it affects more than 250,000 patients yearly. These infections are mostly caused by the migration of microorganisms found on the patient's skin flora at the catheter insertion site. Tremendous efforts have been undertaken to reduce catheter-related sepsis, including improvements to the catheter insertion guidelines and the development of dressings impregnated with antibiotics. These methods help reduce the number of bacteria on the patient's skin but do not eliminate them. No available catheter dressing enables automated and early detection of bacterial growth at the catheter insertion site. Such catheter dressing is a critical need for early detection of CRBSI, allowing for the removal/replacement of the catheter, and, as needed, for early treatment of patients with tailored antibiotic therapy. In addition, it remains a clinical challenge to detect bacterial colonization on the skin at early stages without catheter removal due to the human skin's highly flexible and topographical nature. Flexible biosensors that provide conformal and seamless adherence to the skin can help, but previous studies on the merits of wearable and flexible sensors to detect bacterial infection have been limited to wound infections measured by indirect parameters (e.g., pH) that are subject to change with dietary restrictions and not specific to bacterial infection. Therefore, a significant knowledge gap exists in the use of wearable and flexible sensors integrated with electronics for real-time monitoring of direct bacterial growth at the catheter insertion site for the early detection of CRBSI-related infection risks. The overall objective of this application is to address this need and knowledge gap by developing a fully integrated, wirelessly operated catheter dressing that is capable of monitoring bacterial growth at the catheter insertion site in real-time and non- invasively to enable automated early detection of infection originating from the skin. The central hypothesis is that the electrochemical activity of live bacteria at the catheter insertion site can be directly measured, and acquired data can be classified using machine learning, thereby allowing precise monitoring of extraluminal contamination in real-time. To attain the overall objective, the following two specific aims will be pursued: Aim 1: Develop an integrated catheter dressing (ICD) capable of real-time monitoring of bacterial growth at the catheter insertion site. Aim 2: Validate and optimize the ICD for early detection of catheter-related sepsis on a skin phantom and an animal model. These aims will be accomplished by a team of skilled experts and excellent resources. The proposed research is significant because the ICD can transform the current point-of-care practices, ultimately has the potential to reduce infection risks, health care costs, and morbidity and mortality rates related to CRBSI, and monitor the infection status in real-time, non-invasively, and at the point of care.

项目概要/摘要 导管相关性血流感染 (CRBSI)，也称为导管相关性脓毒症，是最常见的感染之一。 中心静脉导管插入术的致命且昂贵的并发症。 CRBSI 影响数亿人 全世界;仅在美国，每年就有超过 250,000 名患者受到影响。这些感染大多是由 通过在导管插入部位的患者皮肤菌群中发现的微生物的迁移而产生。巨大的 已采取措施减少导管相关脓毒症，包括改进导管插入 指南和浸渍抗生素敷料的开发。这些方法有助于减少 患者皮肤上的细菌数量，但并没有消除它们。没有可用的导管敷料可以 自动和早期检测导管插入部位的细菌生长。这种导管敷料是 迫切需要早期检测 CRBSI，以便移除/更换导管，并根据需要， 为患者提供量身定制的抗生素治疗的早期治疗。此外，检测 由于人体皮肤高度柔韧，无需拔除导管即可在早期阶段在皮肤上定植细菌 和地形性质。灵活的生物传感器可提供与皮肤的保形和无缝粘附 有帮助，但之前关于可穿戴和柔性传感器检测细菌感染的优点的研究已经被 仅限于通过间接参数（例如 pH）测量的伤口感染，这些参数可能会随饮食而变化 限制且不特定于细菌感染。因此，在使用 与电子设备集成的可穿戴和灵活传感器，用于实时监测细菌的直接生长 用于早期检测 CRBSI 相关感染风险的导管插入部位。本次活动的总体目标 应用程序的目的是通过开发完全集成的无线操作来解决这一需求和知识差距 导管敷料能够实时、非连续地监测导管插入部位的细菌生长 有创地实现对源自皮肤的感染的自动早期检测。中心假设是 可以直接测量导管插入部位活细菌的电化学活性，并且 可以使用机器学习对获取的数据进行分类，从而可以精确监控管腔外 实时污染。为实现总体目标，将实现以下两个具体目标： 目标 1： 开发能够实时监测导管细菌生长的集成导管敷料（ICD） 插入位点。目标 2：验证和优化 ICD，以早期检测皮肤上导管相关的脓毒症 幻影和动物模型。这些目标将由熟练的专家和优秀的团队来实现 资源。拟议的研究意义重大，因为 ICD 可以改变当前的护理点 实践最终有可能降低感染风险、医疗费用以及发病率和死亡率 与 CRBSI 相关的比率，并在护理点实时、无创地监测感染状态。