NCT01943474

AccuCath Guidewire Intravenous (IV) Device Versus Conventional IV Catheter In General Nursing Use

The AccuCath Intravenous Catheter System With Retractable Coiled Tip Guidewire and Conventional Peripheral Intravenous Catheters: A Prospective, Randomized, Controlled Comparison by General Hospital Nursing Staff

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 248 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral intravenous (IV) placement, higher completion of therapy, fewer complications, longer dwell times, and higher user 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 and catheter device compared with conventional needle/catheter vascular access devices, in terms of first stick success rates, dwell time, device-related vascular complications and 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, higher completion of therapy, fewer complications, longer dwell times and higher user satisfaction compared to conventional intravenous catheters.

Conditions

• Vascular Access Complication

Interventions

Type	Name	Description
DEVICE	AccuCath IV Catheter Device	Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.
DEVICE	Conventional IV Catheter Device	Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples.

Timeline

• Start date: 2013-04-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2013-09-17
• Last updated: 2017-03-09
• Results posted: 2017-03-09

Locations

1 site across 1 country: United States