Complications Associated With Multiple Central Venous Accesses in the Internal Jugular Vein

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Nossa Senhora da Conceicao

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with preanesthetic planning for insertion of at least two central venous catheters.

Adult ASA I to IV patients (over 18 years old), scheduled to undergo cardiac surgeries, vascular surgeries, major abdominal or thoracic surgeries, liver transplants and lung transplants.

Disqualifiers

Patients with a previous history of central venous thrombosis or central venous stenosis will be excluded from the research protocol.

Patients without preanesthetic planning insertion of at least two central venous catheters.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Multiple central venous lines in two sites separately

    Procedure/Surgery

    Patients with two central venous lines in two sites separately (two central venous sites).

  • Multiple central venous lines in one site (internal jugular vein)

    Procedure/Surgery

    Patients with two concomitant central venous lines in a single internal jugular vein (one central venous site).

Treatment groups

156 Participants
are divided into 2 treatment groups
Group A: Group 1Active comparator 1 intervention
Group B: Group 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Intraoperative

Secondary outcomes

1

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.

Time frame
Up to 30 days after surgery
2

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.

Time frame
Up to 30 days after surgery
3

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.

Time frame
Intraoperative (during central venous line insertion)
4

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.

Time frame
Intraoperative (during central venous line insertion)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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