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

NCT06466226 | Not Yet Recruiting

• 1 other identifier: 75871523.2.0000.5530
• Study Type: interventional
• Target: 156
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Central Venous Catheters; Catheter Complications; Catheter Related Complication

Keywords

central venous access; complications; major surgery

Outcome Measures

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.

  Intraoperative

Secondary Outcomes (5)

• Incidence of catheter-related infection

  Up to 30 days after surgery

• Incidence of central venous catheter malfunction

  Up to 30 days after surgery

• Insertion time of a central venous catheter

  Intraoperative (during central venous line insertion)

• Number of attempts to pass each catheter

  Intraoperative (during central venous line insertion)

• Incidence of venous thrombosis within 30 days

  Up to 30 days after surgery

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Multiple central venous lines in two sites separately

Procedure: Multiple central venous lines in two sites separately

Group 2

EXPERIMENTAL

Multiple central venous lines in a single internal jugular vein

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

Interventions

Multiple central venous lines in two sites separately PROCEDURE

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

Group 1

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

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

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Nossa Senhora da Conceicao: lead

Study Officials

• Andre P Schmidt, MD

  Hospital Nossa Senhora da Conceição

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andre P Schmidt, MD

CONTACT

555133572419; aschmidt@ghc.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking is possible considering the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: June 20, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share