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Central Venous CathetersNCT06466226

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

A study testing Multiple central venous lines in two sites separately and Multiple central venous lines in one site (internal jugular vein) in people with Central Venous Catheters and Catheter Complications, run by Hospital Nossa Senhora da Conceicao.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Multiple central venous lines in two sites separately and Multiple central venous lines in one site (internal jugular vein)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
156 participants
Where
No sites listed yet
Study dates
1 Jul 2024to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Andre P Schmidt, MD contact

555133572419

aschmidt@ghc.com.br

About this study

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

Read the detailed description

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, we 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 do they 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. This consensus primarily references the only comparative and prospective study conducted by Reeves and colleagues in 1995, which compared the passage of multiple central venous catheters in a single site (right internal jugular vein) with placements in different sites.

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.

Our 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.

The 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). The preferred site for the second central venous access in Group I will be the subclavian vein.

Only adult patients classified as ASA I to IV (over 18 years old), scheduled for major surgery, will be eligible for inclusion. Surgical procedures considered for patient allocation include cardiac surgeries, vascular surgeries, major abdominal or thoracic surgeries, liver transplants, and lung transplants. Inclusion criteria specify patients with anesthetic planning for the insertion of at least two central venous catheters.

The primary hypothesis of this study is that the incidence of mechanical complications (cardiac arrhythmias, arterial puncture, hematoma, pneumothorax/hemothorax, catheter insertion failure or inadequate catheter positioning) is equivalent with two punctures in the internal jugular vein when compared to punctures in two different central vessels (internal jugular vein and subclavian and/or femoral vein).

The secondary hypotheses of this study are that the incidence of catheter-related infection, catheter malfunction, and puncture site thrombosis is lower with two punctures in the internal jugular vein when compared to punctures in two different central vessels (internal jugular vein and subclavian and/or femoral).

The study will be designed as a prospective, randomized, non-inferiority, open, parallel clinical trial with two groups for patient allocation. Patients who, according to preoperative anesthetic planning, have indications for multiple central venous accesses (i.e., patients with indications for 2 concomitant central venous catheters) will be randomly allocated to two central venous accesses in two sites separately ( Group I or control group) or two concomitant central venous accesses in a single internal jugular vein (Group II or intervention group). The preferred site for the second group I central venous access is the subclavian.

In this study, adult patients scheduled to undergo major surgery at the Hospital de Clínicas de Porto Alegre, Santa Casa de Porto Alegre and Hospital Nossa Senhora da Conceição will be included. All hospitals involved will have equivalent importance, varying participation according to the number of surgeries performed in the institutions.

Only adult ASA I to IV patients (over 18 years old), scheduled to undergo major surgery in the aforementioned hospitals, will be included.

The surgical procedures considered in this study for patient allocation include: cardiac surgeries, vascular surgeries, major abdominal or thoracic surgeries, liver transplants and lung transplants. Only patients with anesthetic planning for insertion of at least two central venous catheters will be included.

Being tested
Multiple central venous lines in two sites separately, Multiple central venous lines in one site (internal jugular vein)
Keywords
central venous access, complications, major surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multiple central venous lines in two sites separatelyProcedure or 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 or surgery

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

Study groups in NCT06466226
Study groupRoleWhat they receive
Group 1Active comparatorMultiple central venous lines in two sites separately
Receives: Procedure: Multiple central venous lines in two sites separately
Group 2ExperimentalMultiple central venous lines in a single internal jugular vein
Receives: Procedure: Multiple central venous lines in one site (internal jugular vein)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Intraoperative

Secondary outcomes (5)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Intraoperative (during central venous line insertion)

  5. 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.

    Measured: Up to 30 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2024
  2. Study start1 Jul 2024 (estimated)
  3. Primary completion31 Oct 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
156 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06466226
Sponsor's protocol ID
75871523.2.0000.5530
Status last verified
Jun 2024
First submitted
17 May 2024
Last updated
20 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Multiple central venous lines in two sites separately and Multiple central venous lines in one site (internal jugular vein) in people with Central Venous Catheters and Catheter Complications, run by Hospital Nossa Senhora da Conceicao.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Andre P Schmidt, MD (555133572419, aschmidt@ghc.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of composite mechanical complications (time frame: Intraoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.

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