Li Rongmei, Zhou Mian, Sun Lulu, Sha Lili, Xu Biyun, Li Taishun, Tao Tingting, Yuan Ling
Oncology Department, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China.
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China.
Trials. 2024 Jun 12;25(1):380. doi: 10.1186/s13063-024-08141-6.
Maintaining venous access is of great clinical importance. Running a slow continuous infusion to keep the vein open (KVO) is often used in peripheral intravenous catheters (PIVCs). Previous studies have compared the effects of intermittent flushing and continuous infusion via peripherally inserted central catheters (PICCs). In this study, we applied KVO to central venous catheters (CVCs) and compared the occlusion rate of this technique with that of the intermittent flushing technique.
This is a randomized controlled trial of 14 hospitals in China. A total of 250 patients will be recruited in this study, and they will be randomized at a 1:1 ratio. After study inclusion, patients who will undergo CVC insertion will receive intermittent flushing with prefilled saline syringes (control group) or KVO infusion with elastic pumps (test group). All the catheters will be checked for patency by scoping Catheter Injection and Aspiration (CINAS) Classification on Days 3 and 7. The primary outcome is the rate of catheter occlusion in 7 days. Patients will be followed up until 9 days after CVC insertion, catheter occlusion, or catheter removal. The secondary outcomes are the rate of catheter occlusion in 3 days, nurse satisfaction, cost-effectiveness, adverse event rate, catheter-related bloodstream infection rate, catheter-related thrombosis rate, extravasation rate, phlebitis rate, and catheter migration.
We expect that the trial will generate findings that can provide an evidence-based basis for the improvement and optimization of clinical catheter flushing techniques.
Chinese Clinical Trial Registry, ChiCTR2200064007. Registered on 23 September 2022. https://www.chictr.org.cn/showproj.html?proj=177311 .
维持静脉通路具有重要的临床意义。外周静脉导管（PIVC）常采用缓慢持续输注以保持静脉通畅（KVO）。既往研究比较了经外周中心静脉导管（PICC）进行间歇性冲管和持续输注的效果。在本研究中，我们将KVO应用于中心静脉导管（CVC），并比较该技术与间歇性冲管技术的堵塞率。
这是一项在中国14家医院开展的随机对照试验。本研究共招募250例患者，将他们按1:1的比例随机分组。纳入研究后，接受CVC置入的患者将接受预充式生理盐水注射器间歇性冲管（对照组）或弹性泵KVO输注（试验组）。在第3天和第7天，通过导管注射和抽吸（CINAS）分类检查所有导管的通畅情况。主要结局是7天内导管堵塞率。患者将随访至CVC置入、导管堵塞或导管拔除后9天。次要结局包括3天内导管堵塞率、护士满意度、成本效益、不良事件发生率、导管相关血流感染率、导管相关血栓形成率、外渗率、静脉炎发生率和导管移位情况。
我们期望该试验能产生可为临床导管冲管技术的改进和优化提供循证依据的结果。
中国临床试验注册中心，ChiCTR2200064007。于2022年9月23日注册。https://www.chictr.org.cn/showproj.html?proj=177311 。
