Guidewire IV Catheters for Catheter Survival

Overseen By Maureen Cooney, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: William Beaumont Hospitals

Disqualifiers: Under 18, Restricted elbow mobility, Cognitively impaired, Skin complications, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: up to 15 days

360 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Guidewire-assisted intravenous catheter insertion?

Research shows that using a guidewire with peripheral venous catheters leads to higher success rates and satisfaction in patients with difficult venous access. Additionally, a modified guidewire technique was found to be faster than traditional methods in a study with novice operators. ^{1 2 3 4 5}

Is guidewire-assisted intravenous catheter insertion generally safe for humans?

Guidewire-assisted catheter insertion is generally safe, but there are rare risks such as guidewire retention (when the wire is accidentally left inside the body) and arrhythmias (irregular heartbeats) during the procedure. These risks can be minimized with proper training and safety measures. ^{6 7 8 9 10}

How is guidewire-assisted intravenous catheter insertion different from other treatments?

Guidewire-assisted intravenous catheter insertion is unique because it uses a guidewire to help place the catheter more accurately and safely, reducing the risk of complications like catheter misplacement or breakage. This method can improve the success rate of catheter placement compared to traditional techniques. ^{2 4 5 10 11}

What is the purpose of this trial?

This is a prospective, parallel, non-blinded, two-arm randomized controlled trial of intravenous catheter failure evaluating the impact of a built-in guide wire. The objective of this study is to demonstrate that the control ultralong intravenous catheter (IV) without the guide wire is non-inferior to the experimental catheter with the guide wire. After obtaining consent, eligible patients will be randomly allocated to control Arm 1 (ultralong intravenous catheter) or experimental Arm 2 (ultralong intravenous catheter with guide wire) in a ratio of 1:1 via a computer-generated randomization schedule. The participants will be followed to collect data until the catheter is removed.

Research Team

Amit Bahl, MD

Principal Investigator

William Beaumont Hospitals

Eligibility Criteria

This trial is for clinicians at Corewell Health William Beaumont University Hospital who are trained in vascular access and patients over 18 with a specific Vascular Access Score. Patients must be able to give consent, have no cognitive impairments, skin issues at the IV site, or limited elbow mobility.

Inclusion Criteria

I am 18 or older with a high need for vascular access.

Clinician must work in the emergency department at Corewell Health William Beaumont University Hospital (physician, advanced practice provider, nurse, technician)

My doctor is trained in using Operation STICK for vascular access.

Exclusion Criteria

I do not have any cognitive impairments.

I can move my elbow joint freely.

My skin is clear for IV access.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either the control ultralong intravenous catheter or the experimental catheter with guide wire. Data regarding placement, technique, and clinician experience are collected.

up to 15 days

Daily follow-ups

Follow-up

Participants are monitored for catheter functionality, complications, and thrombosis development up to 30 days post discharge.

up to 30 days post discharge

Treatment Details

Interventions

• Guidewire-assisted intravenous catheter insertion

Trial Overview The study compares two types of intravenous catheters: one standard ultralong catheter and another with a built-in guide wire. Participants will be randomly assigned to either group to see if the guide wire improves catheter longevity without increasing complications.

Participant Groups

Group I: Arm 2 (5.71 cm 20 gauge Accucath) Experimental Treatment 1 Intervention

Arm 2 Device: BD 5.71 cm 20 gauge Accucath, ultralong intravenous catheter with guide wire

Group II: Arm 1 (6.35cm 20 gauge ultralong intravenous catheter) Active Control 1 Intervention

Arm 1 Device: B. Braun 6.35cm 20 gauge ultralong intravenous catheter

Who Is Running the Clinical Trial?

William Beaumont Hospitals

Lead Sponsor

Trials

153

Recruited

113,000+

Findings from Research

The guide wire-associated peripheral venous catheter (GAPIV) achieved an 85% first attempt success rate in patients with difficult venous access, compared to only 22% for traditional catheters, indicating a significant improvement in efficacy.

Patient satisfaction scores were notably higher for the GAPIV, with a median score of 5 compared to 2 for traditional catheters, and physician satisfaction also favored the GAPIV due to its ease of use and efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Higher success rates and satisfaction in difficult venous access patients with a guide wire-associated peripheral venous catheter. Chiricolo, G., Balk, A., Raio, C., et al.[2019]

The guidewire-assisted technique for IV cannula placement was taught to 24 novice operators and demonstrated a 22% faster performance compared to the classic cutdown method, averaging two minutes and 13 seconds quicker (P < 0.05).

This modified technique not only improves speed but may also offer additional advantages, making it a potentially safer and more efficient option for IV cannulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A modified wire-guided technique for venous cutdown access. Shockley, LW., Butzier, DJ.[2019]

In a pilot study involving 70 patients with difficult intravenous access, the use of a guidewire during ultrasound-guided peripheral IV placement did not significantly improve the first-pass success rate compared to placement without a guidewire, with rates of 47.1% and 45.7% respectively.

There were no significant differences in the number of attempts, complication rates, or clinician-reported ease of insertion between the two methods, suggesting that the guidewire may not provide additional benefits in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of ultrasound-guided peripheral IV catheter placement in difficult access patients using a guidewire approach. Cochrane, HK., Henwood, PC., Platz, E., et al.[2020]

A guidewire was successfully inserted into a 65-year-old patient with multisystem organ failure without causing any harm, demonstrating the safety of the procedure.

The guidewire became intertwined and knotted with an existing central venous catheter, but both were removed without complications, highlighting the efficacy of careful management in complex medical situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intertwining and knotting of a guidewire with a central venous catheter. Olsfanger, D., Jedeiken, R., Fredman, B., et al.[2019]

The 'zigzag wire technique' involves reshaping a guidewire to improve its trackability during vascular and cardiac catheterization, leading to high success rates in advancing catheters and guidewires.

In a study over the past 2 years, this technique was applied in various challenging cases, achieving a success rate of 94% (17 out of 18) in peripheral arterial cases and 100% success in aortic aneurysm cases, with no reported complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new guidewire technique for difficult cardiac catheterization. Liau, CS., Ho, SG., Chen, SN., et al.[2017]

A systematic analysis of the National Health Service England Never Event database revealed an average of 2 reported cases of retained guidewires per month, with most being discovered after the procedure rather than during it.

The majority of retained guidewires were inserted by trainee doctors, highlighting the need for improved training and system changes, as current safety measures like checklists rely heavily on the operator's memory and do not effectively prevent these incidents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Central Venous Catheter Guidewire Retention: Lessons From England's Never Event Database. Mariyaselvam, MZA., Patel, V., Young, HE., et al.[2023]

The WireSafeTM technique significantly reduced the time taken for sharps disposal during central venous catheter insertion, improving efficiency (8.7 minutes vs. 11.4 minutes with standard practice).

Clinicians reported 100% safe sharps disposal when using the WireSafeTM, compared to 53% unsafe practices in the standard group, highlighting its effectiveness in preventing guidewire retention and enhancing safety during procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

WireSafeTM - A pilot study of a novel safety engineered device designed to prevent guidewire retention and reduce sharps injuries during central venous catheter insertion. Patel, V., Chemban, FM., Samad, S., et al.[2023]

In a study of 69 patients undergoing central venous catheterization, 42% experienced arrhythmic episodes, with higher rates observed when guidewires were inserted to a depth of 20cm compared to 15cm and 17.5cm.

Inserting guidewires to depths of 15cm or 17.5cm significantly reduced the risk of arrhythmias, suggesting that shallower insertions may enhance patient safety during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized comparison of three guidewire insertion depths on incidence of arrhythmia during central venous catheterization. Lee, JM., Lee, J., Hwang, JY., et al.[2017]

Guidewire retention, a rare but serious complication during central venous catheter placement, was reported in 4 cases at our institution, highlighting the risks associated with operator fatigue and inexperience.

Over a 6-year period, the incidence of guidewire loss was found to be 1 in 3,291 procedures, indicating a low but significant risk that emphasizes the need for careful monitoring and supervision during these procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Special article: retained guidewires after intraoperative placement of central venous catheters. Vannucci, A., Jeffcoat, A., Ifune, C., et al.[2013]

In a study involving 99 patients with malpositioned catheters in the internal jugular vein, combining guidewire-assisted reduction technology with an upright posture significantly improved the success rate of catheter repositioning from 69.8% to 94.6%.

This method not only enhances the efficacy of catheter reduction but also suggests a safer approach by protecting the puncture site and distal vein during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guidewire-Assisted Reduction Technology Combined with Postural Reduction Improves the Success Rate of Internal Vein Catheterisation. Li, FX., Li, YP., Zhang, HY., et al.[2022]

In a study of 100 cases comparing conventional guidewires to an improved multi-ply guidewire, the improved version completely eliminated the locking phenomenon, which occurred in 72% of cases with conventional guidewires.

The improved guidewire significantly reduces the risk of locking and potential breakage during central venous catheter insertion, enhancing safety in medical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a safe guidewire. Suzuki, T., Ito, K., Nishiyama, J., et al.[2018]

References

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

Higher success rates and satisfaction in difficult venous access patients with a guide wire-associated peripheral venous catheter. [2019]

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

A modified wire-guided technique for venous cutdown access. [2019]

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

A randomized trial of ultrasound-guided peripheral IV catheter placement in difficult access patients using a guidewire approach. [2020]

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

Intertwining and knotting of a guidewire with a central venous catheter. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

A new guidewire technique for difficult cardiac catheterization. [2017]

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

Central Venous Catheter Guidewire Retention: Lessons From England's Never Event Database. [2023]

7. England pubmed.ncbi.nlm.nih.gov

WireSafeTM - A pilot study of a novel safety engineered device designed to prevent guidewire retention and reduce sharps injuries during central venous catheter insertion. [2023]

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

Randomized comparison of three guidewire insertion depths on incidence of arrhythmia during central venous catheterization. [2017]

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

Special article: retained guidewires after intraoperative placement of central venous catheters. [2013]

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

Guidewire-Assisted Reduction Technology Combined with Postural Reduction Improves the Success Rate of Internal Vein Catheterisation. [2022]

11. Japan pubmed.ncbi.nlm.nih.gov

Development of a safe guidewire. [2018]