Complications Associated With Multiple Central Venous Accesses in the Internal Jugular Vein
NCT Number: NCT06466226
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Central Venous Catheters|Catheter Complications|Catheter Related Complication
Interventions: PROCEDURE: Multiple central venous lines in two sites separately|PROCEDURE: Multiple central venous lines in one site (internal jugular vein)
Sponsor: Hospital Nossa Senhora da Conceicao
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 156
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2027-12-31

Summary:
Patients at risk of significant intraoperative blood loss and/or potential hemodynamic instability often necessitate the placement of two or more central venous catheters, including large bore catheters. In tertiary hospitals, anesthesiologists frequently encounter patients undergoing major surgeries such as liver transplantation, lung transplantation, cardiac surgery, and vascular surgery, who require multiple central venous punctures as part of routine anesthetic management. However, most review and consensus articles do not directly address the utilization of multiple catheters in the same venous site, nor establish formal recommendations regarding this practice. The latest consensus on central venous access from the American Association of Anesthesiologists (ASA), published in 2012, briefly touches upon some aspects related to this practice but does not outline any contraindications. Thus, the investigators have identified a gap in evidence and robust prospective studies addressing the use of more than one catheter in the same site for central venous access. This lacuna underscores the importance of conducting a controlled clinical study in our institutions to establish the efficacy and safety of this approach in the perioperative context. The present study aims to evaluate the incidence of mechanical complications (such as dysrhythmias, arterial puncture, hematoma, pneumothorax/hemothorax, insertion failure, or inadequate positioning) within the first 24 hours after double puncture of the internal jugular vein compared to puncture of two distinct central vessels, in patients undergoing multiple central venous accesses during major surgeries. This study will be designed as a prospective, randomized, non-inferiority, open, parallel clinical trial with two groups for patient allocation. Patients identified for multiple central venous accesses as part of preoperative anesthetic planning will be randomly allocated to either receive two central venous accesses in two separate sites (Group I or control group) or two concurrent central venous accesses in a single internal jugular vein (Group II or intervention group). Only adult patients classified as ASA I to IV (over 18 years old), scheduled for major surgery, will be eligible for inclusion.

Primary Outcome Measures: Incidence of composite mechanical complications, The main outcome is to evaluate the incidence of mechanical complications (dysrhythmias, arterial puncture, hematoma, pneumothorax/hemothorax, insertion failure or inadequate positioning) in the first 24 hours after double puncture of the internal jugular vein compared to puncture of two distinct central vessels, in patients undergoing more than one central venous access in major surgeries., Intraoperative
Secondary Outcome Measures: Incidence of catheter-related infection, To evaluate the incidence of catheter-related infection (central line-associated bloodstream infections - CLABSI) after double puncture of the internal jugular vein compared to puncture of two distinct central vessels, in patients undergoing more than one central venous access in surgery. large., Up to 30 days after surgery|Incidence of central venous catheter malfunction, To evaluate the incidence of central venous catheter malfunction after double puncture of the internal jugular vein compared to the puncture of two different central vessels, in patients undergoing more than one central venous access in major surgeries., Up to 30 days after surgery|Insertion time of a central venous catheter, To evaluate the insertion time of a central venous catheter after double puncture of the internal jugular vein compared to the puncture of two different central vessels, in patients undergoing more than one central venous access in major surgeries., Intraoperative (during central venous line insertion)|Number of attempts to pass each catheter, To evaluate the number of attempts to pass each catheter after double puncture of the internal jugular vein compared to the puncture of two different central vessels, in patients undergoing more than one central venous access in major surgeries., Intraoperative (during central venous line insertion)|Incidence of venous thrombosis within 30 days, To evaluate the incidence of venous thrombosis within 30 days related to double puncture of the internal jugular vein compared to puncture of two different central vessels, in patients undergoing more than one central venous access in major surgeries., Up to 30 days after surgery