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

N/ACompletedNCT01940354

C. R. Bard220 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

220

Conditions

Vascular Access Complications

Interventions

AccuCath IV Catheter SystemDEVICE

Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.

Conventional IV Catheter SystemDEVICE

Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 YearsHealthy volunteers:

Medical Language ↔ Plain English

* Inclusion Criteria: 1. Male or female, age \> or equal to 18 years or \< or equal to 89 years old; 2. Capable and willing to give informed consent; 3. English speaking; 4. Acceptable candidate for an elective, non-emergent peripheral intravenous (PIV) catheter placement as determined by ordering physician; 5. Admitted to study area. Exclusion Criteria: 1. Male or female, \< 18 years old or \> 89 years old; 2. Requirement for emergent IV placement (patient's condition would be compromised if there is a delay in IV placement); 3. Previous venous grafts or surgery at the target vessel access site; 4. Currently involved in other investigational clinical trials (unless permission is granted by other study PI).

Locations (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

First Attempt Success Rate With Peripheral IV (PIV) Catheter Placement

Time frame: Baseline/at catheter placement, PIV placement duration ranges from 3-15 minutes

Secondary Outcomes

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

Time frame: 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

Time frame: Baseline/at catheter placement; PIV placement duration ranges from 3-15 minutes

Data from ClinicalTrials.gov

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