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

Not Applicable

Completed

Interventions: Device: Conventional IV Catheter System
Device: AccuCath IV Catheter System

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.

Recruitment & Eligibility

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).

Arm && Interventions

Group	Intervention	Description
Vascular access via control device	Conventional IV Catheter System	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.
Vascular access via study device	AccuCath IV Catheter System	AccuCath IV Catheter System will be used for IV therapy during interventional radiology procedure. Intervention includes vascular access, fluid infusion, and blood sample removal.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Patient Satisfaction Upon Successful PIV Placement	Baseline/at catheter placement; PIV placement duration ranges from 3-15 minutes	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
Clinician Satisfaction Upon Successful PIV Placement	Baseline/at catheter placement; PIV placement duration ranges from 3-15 minutes	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