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NOT YET RECRUITING
NCT06466226
NA

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

Sponsor: Hospital Nossa Senhora da Conceicao

View on ClinicalTrials.gov

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.

Official title: Incidence of Complications Associated With Multiple Central Venous Accesses in the Internal Jugular Vein: a Randomized Multicenter Non-inferiority Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

156

Start Date

2024-07-01

Completion Date

2027-12-31

Last Updated

2024-06-20

Healthy Volunteers

No

Interventions

PROCEDURE

Multiple central venous lines in two sites separately

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

PROCEDURE

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

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