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

• 批准号: 9919215
• 负责人: Daniel Rogers Burnett
• 金额: $ 91.51万
• 依托单位: PICCOLO MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-30 至 2021-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9919215
• 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-Institutional Clinical Trial; Myocardial; Navigation System; Nurses; Patients; Perforation; Performance; Peripheral; Phase; Pneumothorax; Positioning Attribute; Procedures; Quality of Care; Radiation exposure; Randomized; Real-Time Systems; Receiver Operating Characteristics; 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

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，放置了超过300万个外围插入的中央导管（PICC） 每年提供静脉疗法，在通常通过静脉系统导航的盲人或 没有导航指导。 PICC放置不当是相对常见的，很昂贵，而且很严重 批判性的患者并发症。不幸的是，在盲目位置下，30-55％的PICC提示不是最佳的 进行第一次尝试并需要重新定位，平均直接成本为每位患者223美元， 通常是必要的是将导管线的去除和重新插入，该导管线含有4-6％的气胸风险。 此外，将这些位置不当的PICC中约有17％放置在右心房中， 与多种威胁生命的并发症有关。 PICC的放置不当也经常需要 转介到透明的放射科医生以进行荧光照射引导的中心线位置，这很昂贵 （$ 1,000），需要对患者进行更多的辐射曝光。毫不奇怪，超过一半的PICC是 为60岁以上的患者管理。因此，安全，准确的PICC放置对于提供至关重要 对年长的美国人的高质量护理。尽管与PICC的盲目放置有关的严重不良事件 线，当前的血管接入系统尚未被广泛采用。 TeleflexArrow®G4vps和 Bard Sherlock3CG®TCS是PICC指导系统，使用ECG将PICC提示定位到 正确的位置：包括下级超级腔静脉（SVC）和Cavoatrial Junction（CAJ）的区域。尽管 这些程序通常会限制对确认X射线的需求，它们的成功放置较差且可变 费率（44-84％），比标准PICC高30-70％，需要熟练的员工，并且有明显的 与标准的盲目PICC放置相比，程序时间更长。此外，这些指导系统 依靠使用ECG的使用，ECG对心律不齐的患者无效，这种疾病会影响 所有需要PICC系列的患者中，约有16％。满足准确，安全和成本的需求 有效的PICC放置，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液动力学特征进行实时血管通道的系统 SVC/CAJ的指导。该第二阶段提案的目标是验证Piccolo Smart的准确性 PICC™用于导航和将PICC尖端放入SVC或CAJ中 心律不齐。首先，我们将验证Smart PICC™系统算法的灵敏度以识别正确 心律正常和改变的成年患者的PICC放置（AIM 1）。第二，我们将比较 SMART PICC™系统与最广泛使用的导管导航系统的准确性（BD的Sherlock 3CG®TCS）在正面的优势研究中（AIM 2）。获得的数据将支持FDA 510（k）间隙 并将使我们能够在该提案资助后的2。5年内将系统商业化。