12 Intraosseous Vascular Access Catheter Appears Safe During Extended Dwell: A Preliminary Report

Abstract

Despite relatively few documented complications associated with intraosseous (IO) vascular access, the US Food and Drug Administration (FDA) restricts catheter dwell time to 24 hours for IO devices. This may contribute to placement of central venous catheters for difficult vascular access patients in whom an IO placement would otherwise suffice, contributing to an increased risk for complications and costs. Many clinicians have requested that the IO catheter dwell time be extended to at least 48 hours. A study was designed to determine the safety of IO access when the catheter is left in place for up to 48 hours. The study protocol is being conducted under an Investigational Device Exemption granted by the FDA and was approved by IntegReview Ethical Review Board. Consenting adult volunteers (target N=120) with renal impairment and/or diabetes were randomized to have an IO catheter (Arrow EZ-IO Intraosseous Vascular Access System,Teleflex Inc., Reading, PA) placed in the proximal humerus or proximal tibia by a trained physician. At the discretion of the investigator, subjects were administered midazolam and fentanyl to mitigate anxiety associated with IO insertion and the pain associated with the initial flush. With a slow continuous saline infusion administered by infusion pump, subjects remained in a secured early phase research unit for 48 hours. IO infusion pain was managed initially with IO lidocaine injections, then as needed with oral acetaminophen. For more severe pain, intravenous/intramuscular Toradol or oral hydrocodone/acetaminophen were administered. After 48 hours, an IO aspirate sample was obtained from the in-situ catheter for culturing and an x-ray was taken of the IO insertion site after removal. After 30 days, subjects returned for physical examination and x-ray imaging of the insertion site. As of April 2015, 24 subjects have completed the study with one subject in follow-up. There have been no serious adverse events or complications associated with the IO catheters. The IO aspirate culture reports have shown no growth of microorganisms associated with osteomyelitis; there has been no radiographic evidence of osteomyelitis or other abnormalities associated with the IO catheter. Pain associated with IO catheter dwell and infusion has been well managed with the additional medications (acetaminophen, Toradol, and hydrocodone/acetaminophen); a finding previously unreported. Preliminary results indicate that IO vascular access can be safely maintained for a period up to 48 hours without risk of osteomyelitis or other serious adverse events. Extended dwell time and increased IO access utilization could result in avoidance of serious complications and costs associated with peripherally inserted central catheters (PICC lines), as well as femoral, subclavian, and internal jugular central venous catheters being placed due to difficult vascular access, when central venous access may not be clinically necessary. Using additional analgesics for IO infusion pain management may be more effective than the current standard of only administering lidocaine into the IO space.