Ultrasound-Guided Access for Peripheral Venous Catheterization

(TVA-2026 Trial)

Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Truway Health, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether ultrasound (a technique using sound waves to create images of the body's interior) helps medical workers place a thin tube (catheter) in a vein more successfully on the first try compared to traditional methods. It involves two groups: one using ultrasound-guided peripheral vascular access and the other using standard methods like feeling and looking for veins. The trial aims to determine which method inserts the catheter more quickly and with less pain or fewer complications. Candidates for this trial include individuals who need a vein catheter as part of their medical care and can undergo either method. As an unphased trial, this study offers an opportunity to contribute to improving medical procedures for future patients.

What prior data suggests that ultrasound-guided peripheral vascular access is safe?

Research has shown that using ultrasound to guide catheter placement is generally safe. Studies indicate that ultrasound improves accuracy and reduces complications. Clinical guidelines recommend it as a safe practice. Specifically, one study found that ultrasound helped avoid more invasive procedures in 85% of difficult cases.

This technique also reduces the number of attempts needed to place a catheter successfully, resulting in less discomfort for patients. It also lowers the risks of bruising, swelling, or vein damage. These findings suggest that ultrasound guidance makes the procedure easier and safer, especially for individuals with hard-to-find veins.

Overall, existing evidence supports that ultrasound-guided vascular access is well-tolerated and effective, with fewer problems compared to traditional methods.12345

Why are researchers excited about this trial?

Researchers are excited about ultrasound-guided peripheral vascular access because it offers a potential improvement over traditional methods of inserting IVs. Unlike standard techniques that rely on touch and sight to find veins, this new method uses real-time ultrasound imaging to visualize veins beneath the skin, which could lead to fewer needle sticks and quicker access. This means less discomfort for patients and a higher success rate on the first attempt, which is a big win for both patients and healthcare providers. The trial aims to find out if using ultrasound guidance can significantly reduce complications and improve overall success rates compared to conventional techniques.

What evidence suggests that this trial's techniques could be effective for peripheral venous catheterization?

This trial will compare two methods for peripheral vascular access: standard techniques and ultrasound-guided techniques. Research has shown that ultrasound helps doctors place small tubes, called catheters, into veins more effectively. Specifically, studies found that with ultrasound, doctors succeed on the first try 90% of the time, compared to just 18% with older methods. This proves especially useful for people with hard-to-find veins, often preventing the need for more complicated procedures. Using ultrasound also typically reduces the time needed to place the catheter and requires fewer attempts. Overall, ultrasound speeds up the process and increases success rates. Participants in this trial may experience these benefits if assigned to the ultrasound-guided arm.678910

Who Is on the Research Team?

GC

Gavin C Solomon, M.D.

Principal Investigator

Truway Health, Inc.

Are You a Good Fit for This Trial?

This trial is for adults who need a peripheral IV line placed as part of their medical care. People with conditions making it unsafe or inappropriate to participate, as judged by the clinical team, will not be included.

Inclusion Criteria

I am 18 or older and able to give my consent to join the study.
I am able to have a standard or ultrasound-guided vascular access procedure.
Requires peripheral venous vascular access as part of clinically indicated care
See 6 more

Exclusion Criteria

Immediate life-threatening or emergency circumstances in which study enrollment, consent, assent, parental permission, or randomization could delay medically necessary treatment
Existing functional vascular access that eliminates the clinical need for a new peripheral intravenous catheter
I am under 18 and do not have parental permission or assent, unless allowed by exception.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo peripheral vascular access using either ultrasound-guided or standard techniques

Approximately 30 minutes per procedure
1 visit (in-person)

Follow-up

Participants are monitored for vascular access-related complications and catheter function

72 hours
Remote monitoring

What Are the Treatments Tested in This Trial?

Interventions

  • Standard Peripheral Vascular Access
  • Ultrasound-Guided Peripheral Vascular Access

Trial Overview

The study compares two ways of placing an IV: one uses ultrasound guidance and the other uses standard methods like feeling for veins or looking at them. Participants are randomly assigned to either group to see which method works better on the first try.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Ultrasound-Guided Peripheral Vascular AccessExperimental Treatment2 Interventions
Group II: Standard Peripheral Vascular AccessActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Truway Health, Inc.

Lead Sponsor

Citations

The Rationale for Ultrasound-Guided IV Access

The results of this study showed the success rate at first attempt with ultrasound at 90% vs. 18% in the group randomized to traditional cannulation [6].

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40574336/

The efficacy of ultrasound-guided peripheral intravenous ...

Ultrasound guided cannulation improved the first-attempt success rate compared to the traditional landmark technique in patients with DIVA.

Efficacy of Ultrasound-Guided Peripheral Intravenous ...

In one observational study, the use of ultrasound in the ED prevented the need for CVC placement in 85% of patients with difficult IV access (Au et al. 2012).

Ultrasound-guided peripheral vascular access in children

ultrasound guidance significantly increased first-attempt success (66% vs. 78%; OR 2.61) and improved overall cannulation success.(3)

Guidelines and Evidence for Ultrasound-Guided IV Access

ultrasound guidance significantly improved first-attempt success (RR 1.80; ultrasound-guided peripheral vascular cannulation demonstrated markedly higher first ...

Ultrasound Guided Vascular Access Practical Issues ...

The vein shown was found to be the only one suitable for cannulation and was easily accessible under ultrasound guidance. In such cases, ...

Guidelines and Evidence for Ultrasound-Guided IV Access

Discover how ultrasound-guided IV access is transforming care. Backed by clinical guidelines and strong evidence for safety and success.

Ultrasound Guided Peripheral IV Means Fewer CVCs

The results showed that in 85 of 100 cases (85%) USGPIVs eliminated the need for CVC placement in patients with problematic IV access. These patients also had ...

A Review of Pediatric Ultrasound-Guided Peripheral ...

This article reviews the current literature on pediatric ultrasound-guided peripheral vascular access methods and demonstrates the suitability of point-of-care ...

Guidelines for Performing Ultrasound-Guided Vascular ...

Ultrasound (US) use is recommended as a safety practice to improve successful vessel cannulation and minimize complications dur- ing vascular access.1 This ...