Philbeck Thomas E, McDonald John G, Carew Melvin, Ross Christopher
Teleflex Incorporated, Morrisville, NC, USA.
Victoria Hospital, NHS Fife, Kirkaldy, Scotland, UK.
SAGE Open Med. 2024 Dec 16;12:20503121241306959. doi: 10.1177/20503121241306959. eCollection 2024.
To demonstrate the safety and performance of the Arrow EZ-IO Intraosseous Vascular Access System, particularly in the pediatric patient population, a retrospective observational study was conducted in 2021 and 2022.
Following study design, IRB approval, and investigator selection, data were collected for all patients needing intraosseous access-adult and pediatric. The primary endpoint was the success rate for achieving intraosseous access; the secondary endpoint was the rate of adverse events. Following initial data collection, additional data were collected and a sub-set analysis was conducted to demonstrate the same in pediatric patients only, which is the focus of this report.
Data for 106 pediatric cases were collected. The success rate for achieving intraosseous access and infusion was 96.2%. There were three adverse events in two patients (1.9%); none serious or previously unreported. The mean duration of device use was 60 h (SD = 46). For 46 patients, the device was used for up to 48 h, and for another 45 patients, the device was used for a longer duration.
This report is the first characterization of the safety and performance of the Arrow EZ-IO Intraosseous Vascular Access System when used in the pediatric population for longer dwell times (>24 h), with no serious complications reported. Performance and safety objectives were met. The results of this real-world evidence study are in alignment with findings from the clinical literature concluding that, for pediatric patients, the Arrow EZ-IO Intraosseous Vascular Access System is safe and effective for providing vascular access in urgent, emergent, and medically necessary situations, in which intravenous access is difficult or impossible to obtain. In addition, this study supports the use of intraosseous access for dwell times greater than 24 h.
为了证明箭式EZ-IO骨内血管通路系统的安全性和性能，特别是在儿科患者群体中的情况，于2021年和2022年进行了一项回顾性观察研究。
在完成研究设计、获得机构审查委员会（IRB）批准并选定研究人员后，收集了所有需要骨内通路的成年和儿科患者的数据。主要终点是实现骨内通路的成功率；次要终点是不良事件发生率。在初步数据收集之后，又收集了额外的数据并进行了亚组分析，以仅展示儿科患者中的情况，这也是本报告的重点。
收集了106例儿科病例的数据。实现骨内通路和输液的成功率为96.2%。两名患者发生了三起不良事件（1.9%）；均不严重且无既往未报告的情况。设备使用的平均时长为60小时（标准差=46）。46名患者使用该设备长达48小时，另有45名患者使用时间更长。
本报告首次描述了箭式EZ-IO骨内血管通路系统在儿科患者中使用较长留置时间（>24小时）时的安全性和性能，未报告严重并发症。达到了性能和安全目标。这项真实世界证据研究的结果与临床文献的研究结果一致，即对于儿科患者，箭式EZ-IO骨内血管通路系统在静脉通路难以或无法获得的紧急、突发和医疗必需情况下提供血管通路是安全有效的。此外，本研究支持骨内通路用于留置时间大于24小时的情况。
