Central Venous Catheter Techniques for Shock

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

Trial Summary

What is the purpose of this trial?

Two different techniques for placing a central venous catheter will be compared. The studyu team hypothesizes that clinicians randomized to the peripheral catheter technique will have higher first attempt success rates, fewer procedural complications, and a shorter mean time to procedure completion than physicians assigned to wire through hollow bore needle.

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 data supports the effectiveness of the treatment Central venous catheter insertion for shock?

Central venous catheter placement is a crucial procedure in emergency medicine for administering fluids and medications, and it is frequently used in critical care settings. It is considered effective for providing vascular access in patients with chronic conditions, such as renal failure, and is essential for monitoring and treatment in various medical situations. ^{1 2 3 4 5}

Is central venous catheter insertion generally safe for humans?

Central venous catheter (CVC) insertion is a common procedure but can cause complications like infections, blood clots, and mechanical issues in about 15% of cases. Proper technique and monitoring by a specialized team can help reduce these risks. ^{3 6 7 8 9}

How is central venous catheter insertion unique compared to other treatments for shock?

Central venous catheter insertion is unique because it involves placing a tube directly into a large vein near the heart to deliver medications or fluids quickly and monitor heart function, which is crucial in emergency situations like shock. Unlike other treatments, it uses ultrasound guidance to ensure accurate placement and reduce complications, making it a precise and effective method for managing severe conditions. ^{4 5 10 11 12}

Research Team

Benjamin W Friedman, MD

Principal Investigator

Montefiore Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Insertion of central venous catheters for hemodialysis using angiographic techniques in patients with previous multiple catheterizations. [2016]

2. England pubmed.ncbi.nlm.nih.gov

Inferior thyroid artery pseudoaneurysm associated with internal jugular vein puncture: a case report. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Uses and complications of central venous catheters inserted in a pediatric emergency department. [2022]

4. India pubmed.ncbi.nlm.nih.gov

Bedside prediction of the central venous catheter insertion depth - Comparison of different techniques. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Long-term venous access: indications and choice of site and catheter. [2005]

6. France pubmed.ncbi.nlm.nih.gov

[How to improve central venous catheter use in intensive care unit?]. [2006]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Persistent Left Superior Vena Cava Identified After Hemodialysis Catheter Insertion: A Case Report. [2022]

8. Brazil pubmed.ncbi.nlm.nih.gov

Adverse events related to the use of central venous catheters in hospitalized newborns. [2019]

9. India pubmed.ncbi.nlm.nih.gov

Inserting central venous catheter in emergency conditions in coagulopathic patients in comparison to noncoagulopathic patients. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Central venous access. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Central venous catheterization in the critically ill patient. [2005]

12. United States pubmed.ncbi.nlm.nih.gov

Use of Point-of-Care Ultrasound to Confirm Central Venous Catheter Placement and Evaluate for Postprocedural Complications. [2021]