Jugular vs femoral vein for central venous catheterization in pediatric cardiac surgery (PRECiSE): study protocol for a randomized controlled trial

BACKGROUND: 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. METHODS: 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. DISCUSSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03282292. Registered on 12 September 2017. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-2717-1) contains supplementary material, which is available to authorized users.