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OpenTrials
Completed

NCT Number: NCT01940354

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

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.

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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).

Treatment and study plan

AccuCath IV Catheter System

Device

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

Conventional IV Catheter System

Device

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

Primary outcomes

  1. 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

  1. Patient Satisfaction Upon Successful PIV Placement

    Time frame: 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

  2. Clinician Satisfaction Upon Successful PIV Placement

    Time frame: 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

Sponsors and collaborators

Lead sponsor

C. R. Bard

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2015
First posted
Sep 12, 2013
Registry last updated
Nov 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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