Central Venous Catheter Insertion Site and Colonization in Pediatric Cardiac Surgery

Background: in adult patients, the femoral site of insertion of CVC is notoriously at higher risk of colonization and central-line associated bloodstream infection (CLABSI) than other sites (jugular or subclavian). In pediatric patients, the femoral site is more commonly used than in adult patients, but there is no sound data on catheter colonization and CLABSI related to the insertion site. The experimental hypothesis of this randomized controlled trial (RCT) is that the jugular insertion site is less likely to induce catheter colonization and CLABSI than the femoral site.

Methods: 160 patients under 1 year and scheduled for cardiac surgery will be included in this RCT; patients will be randomly allocated to the jugular (J Group) or Femoral (F Group). CVC insertion will be performed by one out of three selected expert operators.

The primary endpoint is the catheter colonization based on identification of bacterial grow into the catheter at removal time; CLABSI and CRBSI rate based on the same bacterial identification into the catheter tip and in the blood culture performed in case of signs and symptoms of infection.

Secondary endpoints are mechanical complications defined as arterial puncture immediately identified during procedure, hemothorax and pneumothorax; and procedural difficulty during insertion defined as number of attempts, no guidewire progress, duration of the procedure (time from the completion of the sterile precaution barriers and the catheter fixation.

• Internal jugular vein CVC insertion (Procedure): Double lumen CVC insertion in the internal jugular vein

Primary outcomes

• CVC colonization [14 days]: CVC positive culture after removal
• CRBSI [14 days]: Positive CVC culture and blood stream infection for the same organism
• CLABSI [More than 48 hours]: A laboratory-confirmed bloodstream infection where central line was in place for more than 48h.

Secondary outcomes

• Mechanical complications [1 day]: Defined as arterial puncture; hemothorax; pneumothorax
• Procedural difficulty [1 hour]: Defined by number of attempts; no guidewire progress

Sex: All, ages: any to 1 Year

Inclusion Criteria:

Planned cardiac surgery Age <1 year Eligibility for both insertion sites (jugular and femoral) for CVC Availability of at least one out of the three chosen expert operators

Exclusion Criteria:

Emergency surgery Known vascular anatomic anomalies Previous cardiac surgery in the last 6 months No expert operator availability Intensive Care unit before surgery Central venous catheter inside at the time of randomization

Withdraw criteria (only for the first endpoint):

Impossibility to placement catheter in the selected site.

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• Marco Ranucci, MD, Study director, IRCCS Policlinico S. Donato