Central Venous Catheter Techniques for Shock

Recruiting at 1 trial location

Overseen By Benjamin Friedman, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Montefiore Medical Center

Disqualifiers: Coagulopathy, Thrombocytopenia, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 20 minutes

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two techniques for placing a central venous catheter, a thin tube used to deliver medications or fluids directly into a large vein. Researchers compare the standard method, which uses a hollow needle, to a new approach that employs a peripheral IV catheter. They hope the new method will be quicker and cause fewer complications. Adults in the emergency department who need a central line and have no previous issues at the same site might be suitable for this study. As a Phase 4 trial, this research involves an FDA-approved method and aims to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that patients using aspirin or other anti-platelet medications are not excluded.

What is the safety track record for these techniques?

Research has shown that using a peripheral IV, a small tube placed in a vein in the arm, can be safe and effective for central venous access. One study found that administering medication through a peripheral IV to patients with certain heart problems is generally safe. However, if the medication leaks out of the vein, there is a risk of serious tissue injury.

Central venous catheters, thin tubes placed in larger veins, carry their own risks, including possible infection, blood clots, and other complications due to their more invasive nature.

In summary, both methods have safety considerations. Peripheral IVs have fewer major complications but can cause tissue damage if issues arise. Central venous catheters are more invasive and come with different risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different techniques for central venous catheter insertion in patients with shock. Unlike the standard method, which uses a conventional hollow bore needle on a syringe, the experimental approach involves using a peripheral intravenous catheter to initially gain central venous access. This technique could potentially offer a safer and less invasive way to manage shock, reducing complications associated with traditional central venous catheter insertions. By comparing these methods, researchers hope to discover a more effective and patient-friendly approach to treating shock.

What evidence suggests that these central venous catheter techniques are effective for shock?

This trial will compare two techniques for central venous access in emergencies such as shock. One group will use the standard technique, involving a conventional hollow bore needle on a syringe. The other group will use a peripheral IV, a less invasive needle. Research has shown that using a peripheral IV for central venous access might be safer and faster than the usual method with a larger needle. Studies have found that central venous catheters can cause serious problems, such as infections or issues during insertion. Using a peripheral IV to administer medications in emergencies, like shock, is considered safe and often effective, particularly for treating conditions like septic shock, a severe infection that can lead to organ failure. This approach could help reduce complications and speed up treatment. ^{1 3 6 7 8}

Who Is on the Research Team?

Benjamin W Friedman, MD

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

This trial is for adult patients in the emergency department who need a central venous catheter placed using ultrasound guidance. People with existing catheters that could interfere, blood clotting issues, low platelet counts, previous central lines at the same site, or conditions affecting consent are not eligible.

Inclusion Criteria

Adult patients in the emergency department who require ultrasound guided central line placement are eligible for participation and will be referred for participation in the study by the clinical team.

Exclusion Criteria

Anterior border of the target vein deeper than 3.5cm

Previous central venous access at the same anatomical site.

Any indwelling catheter or wire that could potentially interfere with central line placement

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo central venous catheter insertion using either the standard hollow bore needle technique or the peripheral IV catheter technique

20 minutes

1 visit (in-person)

Follow-up

Participants are monitored for procedure-related adverse events and success rates

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Central venous catheter insertion

Trial Overview The study compares two different techniques of inserting a central venous catheter to see which one might be better. Patients will receive one of these techniques when they require a central line during their emergency care.

How Is the Trial Designed?

Group I: Peripheral IV Experimental Treatment 1 Intervention

A peripheral intravenous catheter will be used to obtain initial central venous access

Group II: Standard technique Active Control 1 Intervention

The conventional hollow bore needle on a syringe will be used

Central venous catheter insertion is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Central venous catheter insertion for:

• Administration of vesicant or irritant medications
• Vasopressors
• Chemotherapy
• Total parenteral nutrition
• Poor peripheral IV access
• Renal replacement therapy
• Plasmapheresis
• Apheresis
• Transvenous pacing
• Mixed venous O2 monitoring
• CVP monitoring

Approved in United States as Central venous catheter insertion for:

• Administration of vesicant or irritant medications
• Vasopressors
• Chemotherapy
• Total parenteral nutrition
• Poor peripheral IV access
• Renal replacement therapy
• Plasmapheresis
• Apheresis
• Transvenous pacing
• Mixed venous O2 monitoring
• CVP monitoring

Approved in Canada as Central venous catheter insertion for:

• Administration of vesicant or irritant medications
• Vasopressors
• Chemotherapy
• Total parenteral nutrition
• Poor peripheral IV access
• Renal replacement therapy
• Plasmapheresis
• Apheresis
• Transvenous pacing
• Mixed venous O2 monitoring
• CVP monitoring

Approved in Japan as Central venous catheter insertion for:

• Administration of vesicant or irritant medications
• Vasopressors
• Chemotherapy
• Total parenteral nutrition
• Poor peripheral IV access
• Renal replacement therapy
• Plasmapheresis
• Apheresis
• Transvenous pacing
• Mixed venous O2 monitoring
• CVP monitoring

Approved in China as Central venous catheter insertion for:

• Administration of vesicant or irritant medications
• Vasopressors
• Chemotherapy
• Total parenteral nutrition
• Poor peripheral IV access
• Renal replacement therapy
• Plasmapheresis
• Apheresis
• Transvenous pacing
• Mixed venous O2 monitoring
• CVP monitoring

Approved in Switzerland as Central venous catheter insertion for:

• Administration of vesicant or irritant medications
• Vasopressors
• Chemotherapy
• Total parenteral nutrition
• Poor peripheral IV access
• Renal replacement therapy
• Plasmapheresis
• Apheresis
• Transvenous pacing
• Mixed venous O2 monitoring
• CVP monitoring

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

Published Research Related to This Trial

In a study of 180 patients, the Intra-atrial Electrocardiography (ECG) guided technique resulted in the most accurate positioning of central venous catheters, with 96.67% of catheters placed correctly within 1 cm of the carina.

The Peres' formula method was found to be the least accurate, leading to over-insertion of catheters, while both the landmark technique and ECG guidance provided comparable accuracy in catheter placement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bedside prediction of the central venous catheter insertion depth - Comparison of different techniques. Jayaraman, J., Shah, V.[2022]

Central venous catheter placement is a widely used procedure in intensive care units for access and monitoring, highlighting its importance in critical patient care.

The article discusses various techniques for central line insertion, along with their advantages and disadvantages, and briefly reviews potential complications, emphasizing the need for careful consideration during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Central venous catheterization in the critically ill patient. Agee, KR., Balk, RA.[2005]

Ultrasound guidance during central venous catheterization improves safety by reducing the risk of complications such as inadvertent arterial puncture and accounts for anatomical variations, making the procedure more effective.

The Seldinger technique, which involves using a guidewire for catheter placement, is the primary method for central venous catheterization, but it is important to be aware of potential complications including mechanical, infectious, and thrombotic issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Central venous access. Lockwood, J., Desai, N.[2020]

In a study involving 409 patients with chronic renal failure, the use of angiographic techniques for central venous catheter placement resulted in a high success rate, with only 4.4% requiring alternative methods due to guidewire advancement issues.

The procedure was found to be safe, with only one case of severe arrhythmia reported, indicating that angiographic techniques can effectively minimize complications in patients with a history of multiple catheterizations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insertion of central venous catheters for hemodialysis using angiographic techniques in patients with previous multiple catheterizations. Kotsikoris, I., Zygomalas, A., Papas, T., et al.[2016]

The increasing need for long-term venous access due to advancements in treating various medical conditions highlights the importance of careful preoperative evaluation to identify risk factors like coagulopathy and variations in vascular anatomy.

Standardized techniques for central venous catheter (CVC) placement, such as the Seldinger technique, along with the use of prepackaged kits, can help reduce complications like occlusion and dislodgment, while also encouraging the exploration of alternate venous access routes to prevent overuse of common sites.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term venous access: indications and choice of site and catheter. Taber, SW., Bergamini, TM.[2005]

A rare complication of central venous catheter placement is the development of a pseudoaneurysm in the inferior thyroid artery, which can occur due to accidental puncture during internal jugular vein cannulation.

Using ultrasound guidance during venipuncture significantly reduces the risk of mechanical complications, highlighting its importance in safely performing central line placements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inferior thyroid artery pseudoaneurysm associated with internal jugular vein puncture: a case report. Ruan, J., Zhang, C., Peng, Z., et al.[2022]

Central venous catheters (CVCs) are commonly used in critically ill patients but can lead to adverse events in 15% of cases, highlighting the need for improved risk management strategies.

Implementing consensus recommendations and using Doppler-ultrasound guidance can help reduce complications associated with CVC insertion, but further studies are needed to better understand the risk/benefit ratio compared to peripheral catheters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[How to improve central venous catheter use in intensive care unit?]. Merrer, J., Lefrant, JY., Timsit, JF.[2006]

In a study of 121 pediatric patients who underwent central venous catheter (CVC) insertion in the emergency department, the most common reasons for insertion were lack of peripheral vascular access (64%) and cardiac/respiratory arrest (17%).

The femoral vein was the primary site for CVC insertion (83%), and while there were some complications, none were life-threatening, indicating that CVC placement, especially via the femoral approach, is a safe procedure for critically ill children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Uses and complications of central venous catheters inserted in a pediatric emergency department. Chiang, VW., Baskin, MN.[2022]

Persistent left superior vena cava (PLSVC) is a rare anatomical condition that can complicate central venous catheter (CVC) insertion, occurring in about 0.1-0.5% of the general population, and up to 10% in those with congenital heart defects.

Awareness and proper management of PLSVC during CVC insertion are crucial to minimize risks of complications such as malposition, thrombosis, and infection, ultimately improving patient safety in hemodialysis procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Persistent Left Superior Vena Cava Identified After Hemodialysis Catheter Insertion: A Case Report. Puspitasari, M., Sinorita, H., Bagaswoto, HP., et al.[2022]

In a study of 167 newborns using 241 central venous catheters (CVCs), mechanical adverse events were more common with peripherally inserted central catheters (PICCs), particularly catheter occlusions (19.44%) and ruptures (8.8%).

Surgically inserted CVCs were associated with a higher rate of infectious complications, notably clinical sepsis (16%), highlighting the need for proper insertion techniques and specialized monitoring to enhance safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events related to the use of central venous catheters in hospitalized newborns. Franceschi, AT., da Cunha, ML.[2019]

Point-of-care ultrasound (POCUS) is an effective and quick method for confirming the placement of central venous catheters (CVCs) in the emergency department, providing a reliable alternative to traditional chest radiographs.

POCUS not only confirms correct CVC placement but also helps assess for complications like pneumothorax and misdirected catheters, enhancing patient safety and procedural efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Point-of-Care Ultrasound to Confirm Central Venous Catheter Placement and Evaluate for Postprocedural Complications. Montrief, T., Auerbach, J., Cabrera, J., et al.[2021]

In a study of 59 patients, central venous catheter (CVC) insertion under ultrasound guidance showed no significant difference in complications between patients with coagulopathy and those without, indicating that the procedure is relatively safe for coagulopathic patients.

Overall, only 11.9% of patients experienced complications, with coagulopathic patients showing slightly higher rates of oozing and superficial hematoma, but these were not statistically significant, suggesting that ultrasound guidance may mitigate risks associated with CVC insertion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inserting central venous catheter in emergency conditions in coagulopathic patients in comparison to noncoagulopathic patients. Nasr-Esfahani, M., Kolahdouzan, M., Mousavi, SA.[2020]

Citations

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Analyzing outcomes for peripheral versus central ... This narrative review aims to provide a comprehensive comparison between central and peripheral administration of vasopressor agents, as well as ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34600834/

Safety and efficacy of peripheral versus centrally ... Central venous catheters are associated with serious complications and pose logistical difficulties for insertion. Delivery of vasopressors via ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2838074

Peripheral Vasopressor Use in Early Sepsis-Induced ... Descriptive statistics were used to summarize 28-day peripheral vasopressor and central venous catheter (CVC) complications. Results Of 1563 ...

4. medrxiv.org medrxiv.org/content/10.1101/2023.11.21.23298856v1.full-text

Randomised, controlled, feasibility trial comparing ... Randomised, controlled, feasibility trial comparing vasopressor infusion administered via peripheral cannula versus central venous catheter for ...

5. mdpi.com mdpi.com/2077-0383/12/17/5734

Safety and Outcomes of Peripherally Administered ... The administration of vasopressor infusions via PVC for the management of patients with CS is feasible and safe in patients with cardiogenic shock.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10488618/

Safety and Outcomes of Peripherally Administered ... Conclusions: The administration of vasopressor infusions via PVC for the management of patients with CS is feasible and safe in patients with ...

7. pulmccm.org pulmccm.org/p/peripheral-ivs-are-preferable-to

Peripheral IVs are preferable to central lines for most ... Extravasation with severe tissue injury, including limb loss, is the most-feared adverse outcome from infusing vasopressors peripherally.

8. ccjm.org ccjm.org/content/91/5/287

Do I always need a central venous catheter to administer ... The CV catheter carries risks, however, including procedural complications, infection, thrombosis, and hazards associated with its invasiveness.