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.

项目摘要/摘要 导管相关的血液感染（CRBSI），也称为导管相关的败血症，是最常见的一种，是一种， 中央静脉导管插入术的致命和昂贵的并发症。 CRBSI影响数亿人 全世界;仅在美国，它每年都会影响25万多名患者。这些感染主要引起 通过在导管插入部位的患者皮肤菌群上发现的微生物的迁移。巨大的 已经努力减少导管相关的败血症，包括改进导管插入 指南和敷料抗生素的敷料的发展。这些方法有助于减少 患者皮肤上的细菌数量，但不会消除它们。没有可用的导管敷料可启用 自动化和早期检测导管插入部位的细菌生长。这样的导管敷料是 迫切需要早日检测CRBSI，允许去除/更换导管，并根据需要 用于量身定制的抗生素治疗患者的早期治疗。此外，检测仍然是一个临床挑战 由于人类皮肤高度柔韧性，早期阶段的皮肤上的细菌定殖在没有导管的早期殖民地上 和地形性质。柔性生物传感器可为皮肤提供保形和无缝依从性 帮助，但以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 仅限于通过间接参数（例如pH）测量的伤口感染，这些参数可能会随着饮食而变化 限制，而不是细菌感染的特定。因此，使用了很大的知识差距 与电子设备集成的可穿戴和柔性传感器，以实时监测直接细菌生长 导管插入部位，用于早期发现与CRBSI相关感染风险。总体目标 应用是通过开发完全集成的无线操作来解决这种需求和知识差距 能够实时和非 - 非 - 侵入性，使自动化的早期发现来自皮肤的感染。中心假设是 可以直接测量导管插入部位的活细菌的电化学活性，并且 可以使用机器学习对获得的数据进行分类，从而允许精确监测腔外 实时污染。为了实现总体目标，将追求以下两个具体目标：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） 插入站点。 AIM 2：验证和优化ICD以早期检测皮肤上导管相关的败血症 幻影和动物模型。这些目标将由熟练的专家团队和出色的团队实现 资源。拟议的研究很重要，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，医疗保健成本以及发病率和死亡率 与CRBSI相关的费率，并在医疗点实时，非侵入性监测感染状态。