BACKGROUND The prevention of catheter-related complications is nowadays an important topic of research. Flushing catheters is considered an important clinical procedure in preventing malfunction and several complications such as phlebitis or infection. Considering the latest guidelines of the Infusion Nurses Society, the flushing should be carried out both pre- and post-drug administration, requiring different syringes (with associated overall increased times of preparation/administration of intravenous medication by nurses, and also increasing the need for manipulation of the venous catheter). METHODS/DESIGN A multi-centre, two-arm randomised controlled trial with partially blinded outcome assessment of 146 adult patients. After eligibility analysis and informed consent, participants will receive usual intravenous administration drugs with flushing procedures, with a double-chamber syringe (arm A) or with classic syringes (arm B). The outcomes assessment will be performed on a daily basis by an unblinded ward team, with the same procedures in both groups. Some main outcomes, such as phlebitis and infiltration, will also be evaluated by nurses from a blinded research team and registered once a day. DISCUSSION The study outlined in this protocol will provide valuable insight regarding the effectiveness and safety of this new medical device. The development of this medical device (dual-chamber syringe, for drug and flush solution) seems to be an important step to facilitate nurses' adoption of good clinical practices in intravenous procedures, reducing catheter manipulations. TRIAL REGISTRATION ClinicalTrials.gov, NCT04046770. Registered 13 August 2019.

中文翻译：

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用于外周静脉给药和导管冲洗的双室注射器与经典注射器：随机对照试验的研究方案。

背景技术导管相关并发症的预防是当今的一个重要研究课题。冲洗导管被认为是预防故障和多种并发症（例如静脉炎或感染）的重要临床程序。考虑到输液护士协会的最新指南，冲洗应在给药前和给药后进行，需要不同的注射器（与护士准备/给药静脉药物的总体时间增加相关，也增加了对注射器的需求）静脉导管的操作）。方法/设计 这是一项多中心、双组随机对照试验，对 146 名成年患者进行部分盲法结果评估。经过资格分析和知情同意后，参与者将接受常规静脉注射药物和冲洗程序，使用双室注射器（A 臂）或经典注射器（B 臂）。结果评估将由非盲病房团队每天进行，两组的程序相同。一些主要结果，例如静脉炎和浸润，也将由盲态研究小组的护士进行评估，并每天登记一次。讨论 本协议中概述的研究将为这种新医疗设备的有效性和安全性提供有价值的见解。这种医疗设备（用于药物和冲洗液的双室注射器）的开发似乎是促进护士在静脉手术中采用良好临床实践、减少导管操作的重要一步。试验注册 ClinicalTrials.gov，NCT04046770。注册日期：2019 年 8 月 13 日。