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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare the durability of two types of intravenous (IV) catheters. One type is a standard ultralong IV catheter, and the other is a guidewire-assisted intravenous catheter, which includes a built-in guide wire to potentially aid insertion. Participants will be randomly assigned to receive either the standard catheter or the guidewire catheter. The study targets adults who have difficulty with vein access for IVs, such as when veins are hard to see or feel. As an unphased trial, it offers participants the chance to contribute to research that could enhance IV catheter technology for those with difficult-to-access veins.

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 prior data suggests that the guidewire-assisted intravenous catheter insertion is safe?

Research has shown that the AccuCath Ace™ catheter, equipped with a guide wire, safely navigates difficult blood vessels. This design reduces the need for extra needle pokes, which can be uncomfortable and increase risk. Studies have found that this catheter system improves the chances of successfully placing the IV on the first try compared to regular IV catheters, resulting in fewer attempts and potentially less pain or discomfort.

While specific side effects are not detailed in the sources, the focus on safe and effective placement suggests it is generally well-tolerated. As a commonly used medical device, it likely has a good safety record. However, as with any medical device, some risk may exist, so discussing any concerns with the clinical trial team is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about guidewire-assisted intravenous catheter insertion because it could improve catheter survival rates. Unlike traditional IV catheter techniques, which often face challenges like premature dislodgement or occlusion, this method uses ultralong catheters with built-in guidewires, offering enhanced stability and precision during insertion. The guidewire technology in the BD 5.71 cm Accucath, for instance, promises to reduce complications and extend the lifespan of the catheter, potentially leading to better patient outcomes and fewer IV-related complications.

What evidence suggests that this trial's devices could be effective for catheter survival?

This trial will compare two different guidewire-assisted intravenous catheter systems. Research has shown that using a guidewire with IV catheters can facilitate successful first-attempt insertions. Participants in Arm 1 will receive the B. Braun 6.35 cm 20-gauge ultralong intravenous catheter. Arm 2 will involve the BD 5.71 cm 20-gauge Accucath, which includes a guidewire designed to help catheters remain in place longer. The guidewire smooths and refines the insertion process, reducing the need for reinsertion. This technology may also enhance the overall performance of the IV by maintaining stability in the vein. Early findings suggest that guidewire-assisted catheters can be more effective than traditional ones. ^{1 2 4 6 7}

Who Is on the Research Team?

Amit Bahl, MD

Principal Investigator

William Beaumont Hospitals

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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 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]

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 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]

Citations

1. bd.com bd.com/en-us/products-and-solutions/products/product-families/accucath-ace-intravascular-catheter

AccuCath Ace™ Intravascular Catheter When compared to conventional IV catheters, the AccuCath Ace™ Intravascular Catheter System is designed to increase first attempt success, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06107361

NCT06107361 | Evaluating the Role of the Guidewire in ... 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 ...

3. trials.arthritis.org trials.arthritis.org/trials/NCT04949854

Evaluating the Role of the Guidewire in Peripheral ... IV Catheter survival depends on the length of the catheter inside the veins. Vein depth and angle of insertion play a significant role in choosing the right ...

4. ctv.veeva.com ctv.veeva.com/study/evaluating-the-role-of-the-guidewire-in-peripheral-intravenous-access

Evaluating the Role of the Guidewire in Peripheral ... IV Catheter survival depends on the length of the catheter inside the veins. Vein depth and angle of insertion play a significant role in ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31349906/

A randomized trial of ultrasound-guided peripheral IV catheter ... PIV access was obtained using the Accucath™ 20 gauge × 5.7 cm catheters by way of deployment or non-deployment of the guidewire. Primary outcome measure was ...

6. bd.com bd.com/en-us/products-and-solutions/products/product-page.ac1202250

BD AccuCath Ace™ IV Catheter with BD Cue™ Needle ... When compared to conventional IV catheters, the AccuCath Ace™ Intravascular Catheter System is designed to increase first attempt success, ...

7. bd.com bd.com/en-us/products-and-solutions/products/product-page.ac1201250

BD AccuCath Ace™ IV Catheter, Basic Tray, 20 G x 1.25 in. When compared to conventional IV catheters, the AccuCath Ace™ Intravascular Catheter System is designed to increase first attempt success, ...