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

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

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.

Study Overview

• Status: Completed
• Conditions: Vascular Access Complications
• Intervention / Treatment: Device: AccuCath IV Catheter System; Device: Conventional IV Catheter System

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.

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-4283
      • Hospital of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Vascular access via study device; 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; Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.; Other Names: Rapid Intravascular Start System (RIVS); AccuCath System
ACTIVE_COMPARATOR: Vascular access via control device; 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; Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: C. R. Bard
• Investigators: Principal Investigator: Scott O Trerotola, BA, MD, University of Pennsylvania; Principal Investigator: William Stavropoulos, MD, Hosptial of the University of Pennsylvania; Principal Investigator: Suzanne Sweeney, RN, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (ACTUAL): November 1, 2013
• Study Completion (ACTUAL): March 1, 2015

Study Registration Dates

• First Submitted: September 3, 2013
• First Submitted That Met QC Criteria: September 7, 2013
• First Posted (ESTIMATE): September 12, 2013

Study Record Updates

• Last Update Posted (ACTUAL): November 9, 2017
• Last Update Submitted That Met QC Criteria: October 11, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: IV Catheter comparison; AccuCath versus Conventional IV Catheters; IV Catheter Study; 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
• Other Study ID Numbers: VPW-STP-00003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO