A Prospective, Randomized, Controlled Comparison of First Attempt Success Between an Intravenous Catheter System With a Retractable Coiled Tip Guidewire ...
A Prospective, Randomized, Controlled Comparison of First Attempt Success Between an Intravenous Catheter System With a Retractable Coiled Tip Guidewire and Conventional Peripheral Intravenous Catheters 1,2 1 1 1 1 Jeffrey Forris Beecham Chick, MD, MPH, DABR ; James X. Chen, MD ; Therese Sammarco, MS ; Jesse Chittams, MS , Scott O. Trerotola, MD, FSIR 1
Department of Radiology, Division of Interventional Radiology, Hospital of the University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA; 2Department of Radiology, Division of Vascular and Interventional Radiology, University of Michigan, Ann Arbor, MI
INTRODUCTION
MATERIALS AND METHODS
RESULTS
DISCUSSION
Intravenous (IV) access is critical for interventional radiology (IR) procedures. Because many IR patients come from populations with limited venous reserve, obtaining IV access may be challenging. In spite of extensive innovations in IR, the standard means of achieving peripheral IV (PIV) access, the Angiocath, has changed little, if at all, during the same time period.
This was a single-institution prospective, randomized controlled study using 1:1 assignment to the RG-IV and C-IV groups. Institutional Review Board approval was obtained, the study was carried out in full compliance with the Health Information Portability and Accountability Act, and all patients signed informed consent prior to participation in the trial.
2 patients were withdrawn from the study before any IV attempt was made, 1 in each study arm, leaving 109 patients in each arm of the study. An additional subject was withdrawn (RG-IV arm) after 1 attempt, 1 additional subject was withdrawn (C-IV arm) after a second attempt, and 2 additional subjects were withdrawn after 3 attempts and before crossover (RG-IV arm). Puncture success results before withdrawal for those later withdrawing were included in the results up to the point of withdrawal (intent-to-treat). 2 subjects in the C-IV arm crossed over to the RG-IV arm. 1 did so after 2 attempts (protocol deviation) and had successful RG-IV placement on the third attempt. The second crossed over after 3 failed C-IV attempts, had a failed RG-IV attempt, and then had a successful US-guided puncture using a C-IV.
There has been increasing interest in RG-IV systems, which afford the benefits of Seldinger technique to potentially reduce access-related complications and improve access success rates versus C-IV systems 1-4. In this prospective randomized controlled trial (RCT) comparing RG-IV and conventional IV access, there were no significant differences in first attempt success rate, total attempt number, time to successful IV placement, comfort level, or complication rate between the RG-IV and conventional IV groups. Patients who received conventional IVs reported higher satisfaction scores than those who received RG-IVs.
IR personnel possess an understanding of the value of a guidewire in vascular access. Integrated catheter and guidewire designs have been available for over 20 years for other applications including radial artery catheter placement (Arterial catheterization set; Arrow; Reading, PA). This study sought to evaluate an integrated catheter and guidewire device designed for PIV access (Accucath; Vascular Pathways; Naples, FL). This device uses a nitinol pigtail wire which is passed into the vein and then the venous catheter is passed over the wire. In several studies this device has been shown to reduce the number of punctures required for successful IV access as well as the time to achieve such access. Because of the challenging nature of IR patients when it comes to venous access, this population was felt to represent a test of the technology. The purpose of this study was to compare, in a randomized prospective fashion, an IV system which uses a retractable guidewire (RG-IV) designed to facilitate IV placement with a conventional IV (C-IV) catheter with respect to first-attempt success at placement, number of attempts, time to successful placement, and patient satisfaction.
The primary outcome of the study was first attempt success rate in patients requiring PIV access. Secondary outcomes included number of attempts, time to successful placement, and patient satisfaction upon completion of study. Outpatients undergoing IR procedures for which a PIV was necessary were offered participation in the trial. Inclusion criteria were: age >18 years or
