Comparison of AccuCath IV Catheter and Conventional IV Catheter in Interventional Radiology

Study Overview
=================
Brief Summary
-----------------
The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral IV placement and higher clinician and patient satisfaction compared to Conventional IV Catheters.

Detailed Description
-----------------
This study is designed to evaluate user/physician preference as it relates to use of a 510(k) cleared vascular access peripheral IV catheter device compared with peripheral IV conventional needle/catheter devices, in terms of first stick success rates, adverse events and overall user and patient satisfaction. As noted above, the study is designed to formally test the hypothesis that the AccuCath™ System will exhibit superiority in terms of the rate of successful first attempt peripheral IV placement and higher user and patient satisfaction compared to Conventional IV Catheters.

Official Title
-----------------
A Prospective, Randomized, Controlled Comparison of First Attempt Success Between the AccuCath Intravenous System With Retractable Coiled Tip Guide Wire and Conventional Peripheral Intravenous Catheters With Interventional Radiology Nurses

Conditions
-----------------
Vascular Access Complications

Intervention / Treatment
-----------------
* Device: AccuCath IV Catheter System
* Device: Conventional IV Catheter System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, age > or equal to 18 years or < or equal to 89 years old; Capable and willing to give informed consent; English speaking; Acceptable candidate for an elective, non-emergent peripheral intravenous (PIV) catheter placement as determined by ordering physician; Admitted to study area. Exclusion Criteria: Male or female, < 18 years old or > 89 years old; Requirement for emergent IV placement (patient's condition would be compromised if there is a delay in IV placement); Previous venous grafts or surgery at the target vessel access site; Currently involved in other investigational clinical trials (unless permission is granted by other study PI).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vascular access via study device<br>AccuCath IV Catheter System will be used for IV therapy during interventional radiology procedure. Intervention includes vascular access, fluid infusion, and blood sample removal. | Device: AccuCath IV Catheter System<br>* Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.<br>* Other names: AccuCath System;|
| Active Comparator: Vascular access via control device<br>Conventional IV Catheter System (current catheter) will be used for IV therapy during interventional radiology procedure. Interventions include vascular access, administration of fluids, and blood sample removal. | Device: Conventional IV Catheter System<br>* Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First Attempt Success Rate With Peripheral IV (PIV) Catheter Placement |  | Baseline/at catheter placement, PIV placement duration ranges from 3-15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction Upon Successful PIV Placement | Patient Satisfaction was measured at initial PIV placement using a 5 Point Likert Scale: 5 - Very Comfortable, 4 - Somewhat Comfortable, 3 - Neutral, 2- Somewhat Uncomfortable, 1 - Very Uncomfortable | Baseline/at catheter placement; PIV placement duration ranges from 3-15 minutes | 
| Clinician Satisfaction Upon Successful PIV Placement | Clinician Satisfaction was measured at initial PIV placement using a 5 Point Likert Scale: How easy was the AccuCath™ System to use in comparison to the current catheter? 5 - Easier to Use 4 - Somewhat Easier to Use 3 - Neutral 2 - Somewhat Difficult to Use 1 - Very Difficult to Use | Baseline/at catheter placement; PIV placement duration ranges from 3-15 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IV Catheter Study, IV Catheter comparison, AccuCath versus Conventional IV Catheters, IV Catheter User Preference Comparison, First Attempt Success Rate for IV Catheters, AccuCath Device Performance, Patient Satisfaction with IV Catheters, Clinician Satisfaction with AccuCath Device Performance