Neri Mauro, Lorenzin Anna, Brendolan Alessandra, Garzotto Francesco, Ferrari Fiorenza, De Rosa Silvia, Bonato Raffaele, Villa Gianluca, Bazzano Simona, D''Ippoliti Fiorella, Ricci Zaccaria, La Manna Gaetano, Ronco Claudio
Contrib Nephrol. 2017;190:58-70. doi: 10.1159/000468914. Epub 2017 May 23.
A new technology has recently appeared in the area of extracorporeal therapies for critically ill patients with acute kidney injury. The International Renal Research Institute of Vicenza was involved from the beginning in the development of a new continuous renal replacement therapy (CRRT) equipment with peculiar characteristics. We report the overall experience from design of the new machine to its in vitro and in vivo testing. Kibou® (Asahi Kasei Kuraray Medical Co., Ltd., Tokyo, Japan) is a new multifunctional machine designed for delivering RRT. Kibou® carries out many features of the fourth generation CRRT machines including the possibility of a dynamic prescription and reduction of nursing workload. We describe our first experience with this new device, focusing on several usability and performance parameters. A specific in vitro protocol was designed to analyze the various characteristics and accuracy of performance of the machine. Furthermore, a preliminary in vivo alpha trial with 12 CRRT sessions was performed to test, characterize and evaluate the machine in terms of usability, flexibility and reliability. The in vitro evaluation confirmed an adequate design and a good usability of the machine with accurate delivery of prescribed parameters. No adverse events were observed during the in vivo test that confirmed usability and safety together with accuracy of treatment delivery in different modalities. In general, the machine was rated by physicians and nurses involved in the evaluation as practical and easy to use, although a specific training is required to familiarize with the equipment. A large-scale multicenter beta trial is required to confirm the results reported in this preliminary evaluation in terms of safety, accuracy and performance of Kibou®.
一种新技术最近出现在急性肾损伤重症患者的体外治疗领域。维琴察国际肾脏研究所从一开始就参与了一种具有独特特性的新型连续性肾脏替代治疗（CRRT）设备的研发。我们报告了从新机器设计到其体外和体内测试的整体经验。Kibou®（日本东京旭化成可乐丽医疗株式会社）是一款专为提供肾脏替代治疗而设计的新型多功能机器。Kibou®具备第四代CRRT机器的许多特性，包括动态处方的可能性以及护理工作量的减少。我们描述了使用这款新设备的首次经验，重点关注几个可用性和性能参数。设计了一个特定的体外方案来分析该机器的各种特性和性能准确性。此外，进行了一项包含12次CRRT治疗的初步体内α试验，以在可用性、灵活性和可靠性方面测试、表征和评估该机器。体外评估证实了该机器设计合理且可用性良好，能够准确输送规定参数。在体内测试期间未观察到不良事件，这证实了其可用性、安全性以及不同模式下治疗输送的准确性。总体而言，参与评估的医生和护士认为该机器实用且易于使用，不过需要进行特定培训以熟悉该设备。需要进行大规模多中心β试验，以在安全性、准确性和性能方面确认本初步评估中报告的关于Kibou®的结果。
