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

Simona Silvetti, Tommaso Aloisio, Anna Cazzaniga, Marco Ranucci, Simona Silvetti, Tommaso Aloisio, Anna Cazzaniga, Marco Ranucci

Abstract

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.

Keywords: Catheter-related bloodstream infection (CRBSI); Central line–associated bloodstream infection (CLABSI); Congenital heart disease; Infection; Newborn.

Conflict of interest statement

Ethics approval and consent to participate

The study was approved by the local ethics committee of IRCCS San Raffaele Hospital. The project will be conducted according to the ethical guidelines of the Helsinki Declaration. Information about the study will be presented to the parents in written and oral form. Written informed consent will be obtained from at least one parent, and the right to withdraw from the project at any time without any explanation necessary will be emphasized.

Consent for publication

Not applicable

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Standard Protocol Items: Recommendation for Interventional Trials (SPIRIT) schedule of enrollment, interventions and assessments
Fig. 2
Fig. 2
Central venous catheter placement procedure
Fig. 3
Fig. 3
Central venous catheter management

References

    1. Stenzel JP, Green TP, Fuhrman BP, Carlson PE, Marchessault RP. Percutaneous central venous catheterization in a pediatric intensive care unit: a survival analysis of complications. Crit Care Med. 1989;17:984–988. doi: 10.1097/00003246-198910000-00003.
    1. Odetola FO, Moler FW, Dechert RE, VanDerElzen K, Chenoweth C. Nosocomial catheter-related bloodstream infections in a pediatric intensive care unit: risk and rates associated with various intravascular technologies. Pediatr Crit Care Med. 2003;4:432–436. doi: 10.1097/01.PCC.0000090286.24613.40.
    1. Costello JM, Graham DA, Morrow DF, Potter-Bynoe G, Sandora TJ, Laussen PC. Risk factors for central line-associated bloodstream infection in a pediatric cardiac intensive care unit. Pediatr Crit Care Med. 2009;10:453–459. doi: 10.1097/PCC.0b013e318198b19a.
    1. de Jonge RC, Polderman KH, Gemke RJ. Central venous catheter use in the pediatric patient: mechanical and infectious complications. Pediatr Crit Care Med. 2005;6:329–339. doi: 10.1097/01.PCC.0000161074.94315.0A.
    1. Miguelena D, Pardo R, Morón-Duarte LS. Central venous catheter-related complications in critically ill children. Rev Salud Publica. 2013;15:916–928.
    1. Casado-Flores J, Barja J, Martino R, Serrano A, Valdivielso A. Complications of central venous catheterization in critically ill children. Pediatr Crit Care Med. 2001;2:57–62. doi: 10.1097/00130478-200101000-00012.
    1. American Society of Anesthesiologists Task Force on Central Venous Access Practice guidelines for central venous access: a report by the American Society of Anesthesiologists Task Force on Central Venous Access. Anesthesiology. 2012;116:539–573. doi: 10.1097/ALN.0b013e31823c9569.
    1. Centers for Disease Control and Prevention. Guidelines for the Prevention of Intravascular Catheter-Related Infections. 2011 . Accessed 15 Nov 2017.
    1. Karapinar B, Cura A. Complications of central venous catheterization in critically ill children. Pediatr Int. 2007;49:593–599. doi: 10.1111/j.1442-200X.2007.02407.x.
    1. Camkiran Firat A, Zeyneloglu P, Ozkan M, Pirat A. A randomized controlled comparison of the internal jugular vein and the subclavian vein as access sites for central venous catheterization in pediatric cardiac surgery. Pediatr Crit Care Med. 2016;17:413–419. doi: 10.1097/PCC.0000000000000878.
    1. Freeman JJ, Gadepalli SK, Siddiqui SM, Jarboe MD, Hirschl RB. Improving central line infection rates in the neonatal intensive care unit: effect of hospital location, site of insertion, and implementation of catheter-associated bloodstream infection protocols. J Pediatr Surg. 2015;50:860–863. doi: 10.1016/j.jpedsurg.2015.02.001.
    1. Ranucci M, Isgrò G, De La Torre T, Romitti F, De Benedetti D, Carlucci C, Kandil H, Ballotta A. Continuous monitoring of central venous oxygen saturation (Pediasat) in pediatric patients undergoing cardiac surgery: a validation study of a new technology. J Cardiothorac Vasc Anesth. 2008;22:847–852. doi: 10.1053/j.jvca.2008.04.003.
    1. Aiyagari R, Song JY, Donohue JE, Yu S, Gaies MG. Central venous catheter-associated complications in infants with single ventricle: comparison of umbilical and femoral venous access routes. Pediatr Crit Care Med. 2012;13:549–553. doi: 10.1097/PCC.0b013e31824fbdb4.

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