A Retrospective, Single-center Observational Study on Ultrasound-guided Centrally Inserted Central Catheters Catheter-related Bloodstream Infection and Catheters Failure in Adult Cardiac Surgical Patients.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 480
- Locations
- 1
- Primary Endpoint
- CRBSI
Study Overview
Brief Summary
Central venous catheters, or CVCs, are medical devices used to deliver medications and blood products directly into a patient's large veins. They are now an essential part of modern hospital care, but their use comes with potential complications.
Two of the most serious and well-studied complications are catheter-related bloodstream infections and catheter-related thrombosis (blood clots). These issues not only pose significant health risks to patients but also increase healthcare costs. Fortunately, the frequency of these complications has been reduced by following universally accepted prevention measures, such as:
Proper hand hygiene and skin disinfection before insertion
Using an ultrasound to guide the procedure
Applying best practices for ongoing catheter maintenance
Besides infections and blood clots, other complications like accidental displacement, lumen occlusion (blockage), or a suspected infection can lead to the early, or premature, removal of a CVC before the completion of the patient's treatment.
In patients undergoing cardiac surgery, CVCs are vital. They are used for general anesthesia, medication delivery, and continuous monitoring of a patient's heart and circulatory system. Because of this critical role, it's essential to constantly monitor the incidence of CVC-related complications in this patient population.
This single-center, retrospective study will investigate two primary objectives:
The frequency of catheter-related infections in adult patients undergoing cardiac surgery.
The frequency of premature catheter removals, or "catheter failures," in the same patient group.
The findings from this study will help improve the management of CVCs in cardiac surgery patients and reduce and prevent future complications.
Detailed Description
Over recent decades, numerous studies have examined the long-term complications associated with centrally inserted central catheters (CICCs). Among these, catheter-related bloodstream infections (CRBSIs) have been the most extensively investigated due to their association with increased mortality, prolonged hospital stays, and higher healthcare costs. More recently, premature catheter removal-commonly referred to as catheter failure-has emerged as a frequent yet underexplored complication of CICCs and other vascular access devices (VADs), given its contribution to increased patient risk and healthcare burden.
These findings have informed multiple national and international guidelines for CICC placement and management, resulting in significant advances in the prevention and management of CRBSIs and catheter-related thrombosis (CRT), the major causes of late catheter-related complications.
Currently, ultrasound-guided axillary venous access is considered the preferred central venous access site in intensive care units and, more broadly, in hospitalized patients to reduce CRBSI risk.
In cardiac surgical patients, a CICC is required for the administration of general anesthesia during surgery, as well as for intravenous infusions and medications during the postoperative stay in the intensive care unit and cardiac wards. Traditionally, the right internal jugular vein (IJV) has been favored-likely because it was the most accessible site for central venous cannulation in the pre-ultrasound era.
Current evidence shows that right IJV cannulation is associated with a lower risk of mechanical complications and thrombosis, whereas subclavian or axillary vein (SCV/AV) cannulation is linked to a reduced incidence of CRBSIs. However, SCV/AV access-particularly when performed via blind puncture-carries the risk of pinch-off syndrome and, in rare cases, catheter fracture due to compression between the clavicle and the first rib.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged >18 years.
- •Signed informed consent for contactable patients and those who will be attending the treatment center for follow-up visits.
- •Patients undergoing elective or emergency cardiac surgery during the study period.
- •Cardiac anesthesiologist performing the procedure with >2 years of experience in cardiac surgery and with >100 ultrasound-guided CICC placement procedures per year.
- •Patient with a triple- or quad-lumen CICC placed in the right internal jugular vein.
Exclusion Criteria
- •Patients with active endocarditis.
- •Patients with preoperative sepsis.
- •Patients with infection confirmed by another source.
- •Patients under 18 years of age.
- •Patients who died within 7 days of surgery.
- •Patients with a CICC already in place at the time of surgery.
- •Cardiac anesthesiologist with less than 2 years of cardiac surgery experience and/or fewer than 100 procedures per year.
- •Patients with a CICC placed in the left IJV, subclavian veins, or femoral veins.
Outcomes
Primary Outcomes
CRBSI
Time Frame: Perioperative
Incidence of catheter related bloodstream infection. No of CRBSI/Total catheters\*100. No of CRBSI/1000 catheter days.
Secondary Outcomes
- Catheter failure(Perioperative)
Investigators
Raffaele Mandarano
Principal Investigator
Azienda Ospedaliero-Universitaria Careggi