Clinical trial NCT02469038: Ultrasound-Guided Peripheral Venous Access Using AccuCath
Official title: Randomized, Controlled Study of Ultrasound-Guided Peripheral Venous Access Using AccuCath Versus Ultrasound-Guided Conventional Intravenous Catheter in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intravenous Access
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2015-06-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: While peripheral venous cannulation is among the most common procedures performed in clinical settings, it is estimated that PIV insertion fails for 6 million patients annually. Failure to establish peripheral venous access in the emergency department is a costly problem, leading to delays in diagnostics and treatment and requiring alternative sites for vascular access. These alternative methods can lead to higher complications rates, decreased patient satisfaction, and increased utilization of nursing and physician time. Complications from PIV failure also pose a significant financial burden to the healthcare system.

Ultrasound guidance has been shown to greatly improve the process of localizing vessels for cannulation. In a healthcare climate that is increasingly focused on outcomes and cost-effectiveness, ultrasound-guided peripheral venous cannulation has become not only a viable but often the preferred method in patients with difficult venous access. Nevertheless, studies to date on ultrasound-guided peripheral venous cannulation have revealed some shortcomings, such as premature failure and low first attempt success rates.

The purpose of our study is to assess whether ultrasound-guided cannulation of a AccuCath catheter, which has a coiled tip guidewire, is superior to ultrasound-guided cannulation of a conventional peripheral IV catheter across clinical outcomes relevant to the emergency department setting.

Detailed description: Peripheral venous cannulation is among the most common procedures performed in clinical settings and is a prerequisite for fluid resuscitation, administration of medications, and diagnostic testing \[1,2\]. In the United States, approximately 300 million peripheral intravenous catheters (PIV) are inserted annually \[1\], and more than 25% of all visits to the emergency department require intravenous catheters for parenteral fluid administration \[3\]. Providers in the emergency department have become adept at establishing peripheral venous access, but it is estimated that PIV insertion fails for 6 million patients annually \[1\].

Many factors are thought to be associated with difficult venous access, which is typically defined to be at least two failed attempts at establishing intravenous access \[3\]. Intravenous drug abuse, obesity, multiple hospitalizations, and chronic medical problems including diabetes, sickle cell disease, end-stage renal disease, and cancer are predisposing factors for difficult venous access \[2-5\]. Prior studies have reported prevalence of difficult venous access ranging from 8% to 23% \[2-5\]. Failure to establish peripheral venous access in the emergency department is a costly problem, leading to delays in diagnostics and treatment and requiring alternative sites for vascular access such as external jugular, intraosseous, or central venous access \[3\]. These alternative methods can lead to higher complications rates, decrease patient satisfaction, and increase utilization of nursing and physician time \[6\]. Central venous catheterization, which is often used when traditional venous cannulation methods fail, has an overall complication rate of 15%, and complications include arterial puncture, pneumothorax, deep vein thrombosis, and infection \[7,8\]. These complications pose a significant financial burden to the healthcare system, as the cost associated with a single central venous catheter related infection in 2002 was estimated to be $34,508 to $56,000 and the median payout for claims resulting from central venous catheter related injuries was $100,7502.

In the past few decades, ultrasound guidance has greatly improved the process of localizing vessels for cannulation, especially in patients with abnormal vascular anatomy or difficult venous access, thereby providing many benefits over landmark-based techniques. Ultrasound guided venous cannulation dates back to 1984, when Legler and Nugent showed that the single pass success rate for internal jugular (IJ) cannulation could be improved to 77.3% using Doppler ultrasound versus 28.6% for the traditional landmark-based approach \[9\]. Since the report of real-time ultrasonographic guidance of IJ catheter placement by Yonei et al. in 1986 \[10\], ultrasound guided central venous cannulation has repeatedly been shown to increase success rates, decrease complication rates, and improve patient satisfaction \[1,2,11-15\]. Based on the advantages offered by ultrasound guidance, the Agency for Healthcare Research and Quality now recommends real-time ultrasonographic guidance for all central venous access \[13,16\].

The ultrasound-guided approach was adapted for peripheral venous access in the emergency department by Keyes et al. in an uncontrolled study that demonstrated a 91% success rate for ultrasound-guided cannulation of brachial and basilica veins \[17\]. A subsequent controlled study validated a higher success rate in the ultrasonographic (97%) versus control (33%) group in patients identified to have difficult PIV access and also showed that the ultrasonographic group required less time to successful cannulation, fewer percutaneous punctures, and resulted in greater patient satisfaction than the traditional landmark-based approach \[13\]. Furthermore, ultrasound-guidance for peripheral venous cannulation has been shown to prevent the need for central venous catheterization in 85% of patients with difficult venous access \[2\] and used 40% fewer kits per patient than landmark-guided placement of catheters \[11,18\]. In a healthcare climate that is increasingly focused on outcomes and cost-effectiveness, ultrasound-guided peripheral venous cannulation has become not only a viable but often the preferred method in patients with difficult venous access.

Nevertheless, studies to date on ultrasound-guided peripheral venous cannulation have revealed some shortcomings. Conventional IV catheters placed under ultrasound guidance have been prone to premature failure with failure rates of 8% \[7,17\] in the first hours after placement and 47% in the first 24 hours, most commonly due to infiltration \[7\]. These failure rates are significantly higher compared with 2% at 24 hours and 10% at day 4, which has been reported for standard peripheral IV catheters \[7,19\]. Moreover, while overall success rates range from 90% to 100% with multiple attempts \[2,7,13,20\], first attempt success rate has been less impressive, ranging from 46% to 71% \[13,20\]. Our study will assess whether the AccuCath catheter with its integrated guidewire can address these shortcomings and demonstrate superiority over conventional PIV catheters across clinical outcomes relevant to the emergency department setting.

While catheters with guidewires have long been used when placing central and arterial lines, they have largely been absent from PIV placement. The AccuCath catheter is differentiated from a conventional IV catheter in two principal ways. The catheter material consists of polyether block amide, which is a thermoplastic elastomer with softness and flexibility designed to decrease vessel wall irritation and mechanical phlebitis \[21\]. In addition, the integrated guidewire facilitates catheter insertion and limits vessel damage \[21\]. A prospective, randomized, controlled study has shown a first attempt success rate of 89% for a catheter with guidewire versus 47% for conventional IV along with lower complication rates of 8% for the cathether with guidewire and 52% for conventional IVs \[21\]. This study was performed in an inpatient setting on patients receiving elective, non-emergent PIVs \[21\].

Our study will be important in determining whether AccuCath's superior first attempt success rate and lower complication rate can be replicated in emergent PIVs in the emergency department setting. These improvements could translate to cost savings from decreased utilization of physician and nursing time, fewer number of PIV catheters used, higher patient satisfaction from fewer percutaneous punctures, and less complications from infiltration and phlebitis.

The objectives of the study are to:

1. In patients who fail traditional non-ultrasound IV catheter placement, compare ultrasound-guided cannulation of AccuCath catheters versus ultrasound-guided cannulation of conventional IV catheters in ED patients across the following clinical parameters: first attempt success rate, procedure time from the point of first percutaneous puncture to successful cannulation, total number of percutaneous punctures required for successful cannulation, and total number of IV catheters required for successful cannulation.
2. Assess patient and provider satisfaction with each catheter system on a 5-point Likert scale.
3. Check for clinical and demographic differences between patient groups that were successfully cannulated on first attempt versus those that required multiple attempts.

We hypothesize that:

1. Ultrasound-guided cannulation of AccuCath IV catheters will demonstrate a higher first attempt success rate, require less procedure time, require fewer percutaneous punctures, and utilize fewer catheters than ultrasound-guided cannulation of conventional IV catheters in ED patients.
2. Patients and providers will be more satisfied with AccuCath IV catheters versus conventional IV catheters in the ED setting.
3. There will be no statistically significant clinical and demographic differences between patient groups that are successfully cannulated on first attempt versus those that required multiple attempts.

Eligibility criteria: Inclusion Criteria:

* Adult patients with IV access need

Exclusion Criteria:

* Lack of decisional capacity (e.g., intoxication, dementia, delirium, developmental delay), prior venous grafts or surgery at target IV site, not an acceptable candidate for ultrasound-guided PIV per Mitchell ED protocol (i.e. 3 failed attempts by nurses- 2 by primary nurse, 1 by senior nurse)

Primary outcomes:
measure: First Attempt Success Rate
timeFrame: During length of stay in emergency room up to 24 hours
Secondary outcomes:
measure: IV Procedure Time
timeFrame: During length of stay in emergency room up to 24 hours
Other outcomes:
measure: Total Number of Percutaneous Punctures
timeFrame: During length of stay in emergency room up to 24 hours
measure: Total Number of IV Catheters
timeFrame: During length of stay in emergency room up to 24 hours
measure: Patient Satisfaction Data
timeFrame: During length of stay in emergency room up to 24 hours
measure: Provider Satisfaction Data
timeFrame: During length of stay in emergency room up to 24 hours
measure: Clinical and Demographic Information
timeFrame: During length of stay in emergency room up to 24 hours
Locations:
Study officials:
affiliation: University of Chicago
name: Yong Suh, MD MBA MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: Gregg Helland, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: Thomas Spiegel, MD MBA
role: PRINCIPAL_INVESTIGATOR
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