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

Vascular Access Complications Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01940354
• Other study ID #: VPW-STP-00003
• Status: Completed
• Phase: N/A
• First received: September 3, 2013
• Last updated: October 11, 2017
• Start date: August 2013
• Est. completion date: March 2015

Study information

• Verified date: October 2017
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: March 2015
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

• 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).

Related Conditions & MeSH terms

• Vascular Access Complications

Intervention

Device:
• AccuCath IV Catheter System
Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.
• Conventional IV Catheter System
Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First Attempt Success Rate With Peripheral IV (PIV) Catheter Placement		Baseline/at catheter placement, PIV placement duration ranges from 3-15 minutes
Secondary	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
Secondary	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