A Novel, Low-Cost Device to Guide Peripherally Inserted Central Catheter (PICC) Line Placement

一种用于引导外周中心静脉置管 (PICC) 导管置入的新型低成本设备

基本信息

批准号：
10019319
负责人：
Daniel Rogers Burnett
金额：
$ 56.16万
依托单位：
PICCOLO MEDICAL, INC.
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-09-30 至 2022-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10019319
关键词：
Address Adopted Adoption Adult Adverse event Affect Age Algorithms American Anatomy Area Under Curve Arrhythmia Automobile Driving Blinded Blood Vessels Blood flow Cardiac Catheters Characteristics Clinic Clinical Clinical Research Critical Illness Data Detection Devices Direct Costs Distal EKG P Wave Electrocardiogram Excision Family suidae Funding Future Goals Head Heart Atrium Heart Valves Infusion procedures Intervention Intravenous Lead Life Location Measures Medical Modeling Multi-site clinical study Myocardial Navigation System Nurses Patients Perforation Performance Peripheral Phase Pneumothorax Positioning Attribute Procedures Quality of Care ROC Curve Radiation exposure Randomized Real-Time Systems Research Resolution Right atrial structure Risk Roentgen Rays Savings Serious Adverse Event Signal Transduction Superior vena cava structure System Technology Thermodilution Thoracic Radiography Thrombus Time Training United States Venous system Work base blind cohort cost cost effective follow-up heart rhythm hemodynamics improved in vivo innovation machine learning algorithm novel point of care pre-clinical radiologist sensor

项目摘要

Abstract In the United States alone, more than three million peripherally inserted central catheters (PICCs) are placed each year to provide IV therapies, where navigation through the venous system is typically performed blind, or without navigation guidance. Improper PICC placement is relatively common, is costly, and has serious complications for critically-ill patients. Unfortunately, under blind placement 30-55% of PICC tips are not optimally placed on the first attempt and require repositioning, which has an average direct cost of $223 per patient and often necessitates the removal and reinsertion of the catheter line that carries a 4-6% risk of pneumothorax. Moreover, approximately 17% of these improperly positioned PICCs are placed into the right atrium, which is associated with a multitude of life-threatening complications. Improper placement of PICCs also often requires referral to an interventional radiologist for fluoroscopic-guided central line placement, which is expensive ($1,000) and requires more radiation exposure for the patient. Not surprisingly, over half of all PICCs are administered to patients over the age of 60. Therefore, safe and accurate PICC placement is critical for providing high-quality care to older Americans. Despite serious adverse events associated with blind placement of PICC lines, current vascular access systems have not been widely adopted. The Teleflex ARROW® G4 VPS and the Bard Sherlock 3CG® TCS are PICC guidance systems that employ ECG for positioning the PICC tip into the correct location: the region that includes the lower superior vena cava (SVC) and cavoatrial junction (CAJ). While these procedures often limit the need for a confirmatory X-ray, they have poor and variable successful placement rates (44-84%), are 30-70% more expensive than standard PICCs, require skilled staff, and have significantly longer procedure times as compared to standard, blind PICC placement. Additionally, these guidance systems rely on the use of ECG, which is ineffective for patients with cardiac arrhythmias, a condition that affects approximately 16% of all patients requiring a PICC line. To address the need for accurate, safe, and cost- effective PICC placement, Piccolo Medical has developed the Smart PICC™ system, a point-of-care catheter system that uses unique hemodynamic signatures of different vascular regions for real-time vascular access guidance into the SVC/CAJ. The goals of this Phase II proposal are to validate the accuracy of the Piccolo Smart PICC™ for navigation and placement of a PICC tip into the SVC or CAJ for adult patients with and without cardiac arrhythmias. First, we will verify the sensitivity of the Smart PICC™ system algorithm to identify correct PICC placement in adult patients with both normal and altered cardiac rhythms (Aim 1). Second, we will compare the accuracy of the Smart PICC™ system to the most widely used catheter navigation system (BD’s Sherlock 3CG® TCS) in a head-to-head superiority study (Aim 2).The data obtained will support FDA 510(k) clearance and will allow us to commercialize the system within ~2.5 years of the funding of this proposal.

抽象的仅在美国，就放置了超过 300 万根外周静脉置入中心静脉导管 (PICC) 每年提供静脉注射治疗，其中静脉系统的导航通常是盲目进行的，或者没有导航引导的不当 PICC 放置相对常见，成本高且后果严重。不幸的是，在盲目放置的情况下，30-55% 的 PICC 尖端并不是最佳的。第一次尝试就放置并需要重新定位，每个患者的平均直接成本为 223 美元通常需要移除并重新插入导管，这会带来 4-6% 的气胸风险。此外，大约 17% 的位置不当的 PICC 被放置在右心房，即 PICC 的不当放置通常还与多种危及生命的并发症相关。转诊至介入放射科医生进行荧光镜引导的中心线放置，这是昂贵的（1,000 美元）并且需要患者接受更多的辐射，不足为奇的是，超过一半的 PICC 都接受了放射治疗。适用于 60 岁以上的患者。因此，安全、准确的 PICC 置入对于提供尽管盲目放置 PICC 会产生严重的不良事件，但仍为美国老年人提供高质量的护理。目前，Teleflex ARROW® G4 VPS 和血管通路系统尚未得到广泛采用。 Bard Sherlock 3CG® TCS 是 PICC 引导系统，利用 ECG 将 PICC 尖端定位到正确位置：包括下上腔静脉（SVC）和腔房交界处（CAJ）的区域。这些程序通常限制了 X 光检查的需要，它们的成功放置效果较差且存在差异费率 (44-84%)，比标准 PICC 贵 30-70%，需要熟练的员工，并且具有显着的优势此外，这些引导系统与标准的盲人 PICC 放置相比，手术时间更长。依赖于心电图的使用，这对于患有心律失常的患者来说是无效的，心律失常是一种影响健康的疾病。大约 16% 的患者需要 PICC 导管来满足准确、安全和成本低廉的需求。为了有效地放置 PICC，Piccolo Medical 开发了 Smart PICC™ 系统，这是一种护理点导管使用不同血管区域的独特血流动力学特征进行实时血管通路的系统该第二阶段提案的目标是验证 Piccolo Smart 的准确性。 PICC™ 用于将 PICC 尖端导航并放置到 SVC 或 CAJ 中，适用于患有或不患有这种疾病的成年患者首先，我们将验证 Smart PICC™ 系统算法识别正确心律失常的灵敏度。 PICC 放置在心律正常和改变的成年患者中（目标 1）其次，我们将进行比较。 Smart PICC™ 系统与最广泛使用的导管导航系统（BD 的 Sherlock 3CG® TCS）进行头对头优势研究（目标 2）。获得的数据将支持 FDA 510(k) 许可并使我们能够在该提案资助后约 2.5 年内将该系统商业化。