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.
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
- Conditions the study is for
- Central Venous Catheters, Catheter Complications, Catheter Related Complication
- 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.
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 group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Multiple central venous lines in two sites separately Receives: Procedure: Multiple central venous lines in two sites separately |
| Group 2 | Experimental | Multiple 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.
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)
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
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
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)
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)
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.
- First posted20 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Venous CathetersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hospital Nossa Senhora da Conceicao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andre P Schmidt, MD, Principal investigator, Hospital Nossa Senhora da Conceição
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Complications Associated With Multiple Central Venous Accesses in the Internal Jugular Vein: a Randomized Multicenter Non-inferiority Clinical Trial
- ClinicalTrials.gov ID
- NCT06466226
- Acronym / sponsor ID
- 75871523.2.0000.5530
- Keywords
- central venous access, complications, major surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Hospital Nossa Senhora da ConceicaoUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: Multiple central venous lines in two sites separatelyMultiple central venous lines in two sites separately |
| Group 2 | Experimental | Procedure: Multiple central venous lines in one site (internal jugular vein)Multiple central venous lines in a single internal jugular vein |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiple central venous lines in two sites separatelyPatients with two central venous lines in two sites separately (two central venous sites). | Procedure or surgery | Group 1 |
| 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). | Procedure or surgery | Group 2 |
Primary outcome
Incidence of composite mechanical complications
Time frame: Intraoperative
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.
5 secondary outcomes
Incidence of catheter-related infection
Time frame: Up to 30 days after surgery
Incidence of central venous catheter malfunction
Time frame: Up to 30 days after surgery
Insertion time of a central venous catheter
Time frame: Intraoperative (during central venous line insertion)
Number of attempts to pass each catheter
Time frame: Intraoperative (during central venous line insertion)
Incidence of venous thrombosis within 30 days
Time frame: Up to 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andre P Schmidt, MD principal investigator
Hospital Nossa Senhora da Conceição
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.