Silvetti Simona, Aloisio Tommaso, Cazzaniga Anna, Ranucci Marco
Department of Cardiovascular Anesthesia and Intensive Care, IRCCS Policlinico San Donato, Via Morandi 30, 20097 San Donato Milanese, Milan, Italy.
Trials. 2018 Jun 25;19(1):329. doi: 10.1186/s13063-018-2717-1.
Placement of central venous catheters (CVCs) is essential and routine practice in the management of children with congenital heart disease. The purpose of the present protocol is to evaluate the risk for infectious complications in terms of catheter colonization, catheter line-associated bloodstream infections, and catheter-related bloodstream infections (CRBSIs), and the mechanical complications from different central venous access sites in infants and newborns undergoing cardiac surgery.
One hundred sixty patients under 1 year of age and scheduled for cardiac surgery will be included in this randomized controlled trial (RCT); patients will be randomly allocated to the jugular or femoral vein arms. CVC insertion will be performed by one of three selected expert operators.
The choice of the insertion site for central venous catheterization can influence the incidence and type of infectious complications in adults but this is not unanimously evidenced in the pediatric setting. The experimental hypothesis of this RCT is that the jugular insertion site is less likely to induce catheter colonization and CRBSI than the femoral site.
ClinicalTrials.gov Identifier: NCT03282292 . Registered on 12 September 2017.
在先天性心脏病患儿的治疗中，放置中心静脉导管（CVC）是必不可少的常规操作。本方案的目的是评估导管定植、导管相关血流感染和导管相关血流感染（CRBSI）方面的感染并发症风险，以及接受心脏手术的婴儿和新生儿不同中心静脉通路部位的机械并发症。
160例1岁以下计划接受心脏手术的患者将纳入本随机对照试验（RCT）；患者将被随机分配至颈静脉或股静脉组。CVC插入将由三名选定的专家操作人员之一进行。
中心静脉置管插入部位的选择可影响成人感染并发症的发生率和类型，但在儿科环境中这一点并未得到一致证实。本RCT的实验假设是，颈静脉插入部位比股静脉部位诱发导管定植和CRBSI的可能性更小。
ClinicalTrials.gov标识符：NCT03282292。于2017年9月12日注册。
