Intraosseous vascular access using the EZ-IO can be safely maintained in the adult proximal humerus and proximal tibia for up to 48 h: Report of a clinical study

Abstract

Background: Historically, intraosseous (IO) vascular access devices cleared to market by the US FDA have been restricted to 24-h use. An observational study was conducted to determine the safety of IO access for a period up to 48 h in adult volunteers. Methods: A 2-arm randomized, stratified, parallel assignment, prospective interventional study was conducted at ICON Early Phase Services in San Antonio, Texas, United States. Study subjects were adult volunteers who were healthy or with a history of mild to moderate renal disease and/or controlled diabetes. Subjects were randomized to receive IO access (Arrow EZ-IO Vascular Access System, Teleflex Medical Incorporated, Morrisville, NC, USA) in the proximal humerus or the proximal tibia and maintain the indwelling catheter for 48 h. Subjects were monitored for the entire dwell time. A culture specimen was drawn from the indwelling catheter tip before removal and insertion site x-rays were taken. Results: 121 subjects were randomized: 79 healthy, 39 with diabetes, and three with diabetes and renal insufficiency. The mean catheter dwell time was 48.0 ± 0.2 h. Overall first attempt success rate was 98.4%. Infusion pain was the most commonly reported adverse event. There were no serious complications or unanticipated adverse events. Conclusions: This is the first known study examining the safety of IO access over a 48-h dwell time. The study corroborates the literature findings, demonstrates device safety, and provides evidence supporting the extended indication for a dwell time to 48 h in adult patients. IO placement and infusion best practices/guidelines were confirmed or established.