Central Venous Catheter Insertion Site and Colonization in Pediatric Cardiac Surgery

Study Overview
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Brief Summary
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Randomized controlled trial comparing femoral vs internal jugular insertion site of central venous catheters (CVC) in newborns and infants undergoing cardiac surgery. The experimental hypothesis is that the jugular insertion site is superior to the femoral in terms of catheter colonization.

Detailed Description
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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.

Official Title
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Central Venous Catheter Insertion Site and Catheter Colonization and Bloodstream Infection in Pediatric Cardiac Surgery

Conditions
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Central Line-associated Bloodstream Infection (CLABSI), Central Venous Catheter Associated Bloodstream Infection, Heart; Surgery, Heart, Functional Disturbance as Result, Congenital Heart Disease, Newborn; Infection

Intervention / Treatment
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* Procedure: Internal jugular vein CVC insertion


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jugular<br>CVC insertion in the left or right internal jugular vein | Procedure: Internal jugular vein CVC insertion<br>* Double lumen CVC insertion in the internal jugular vein<br>|
| Active Comparator: Femoral<br>CVC insertion in the right or left femoral vein | Procedure: Internal jugular vein CVC insertion<br>* Double lumen CVC insertion in the internal jugular vein<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CVC colonization | CVC positive culture after removal | 14 days | 
| CRBSI | Positive CVC culture and blood stream infection for the same organism | 14 days | 
| CLABSI | A laboratory-confirmed bloodstream infection where central line was in place for more than 48h. | More than 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanical complications | Defined as arterial puncture; hemothorax; pneumothorax | 1 day | 
| Procedural difficulty | Defined by number of attempts; no guidewire progress | 1 hour |