Use of a functionalized introducer sheath and bioimpedance spectroscopy for real-time detection of vascular access complications

Abstract

Internal bleeding complications (IBCs) occurring at vascular access sites are associated with worsening patient outcomes and increased costs. This study assessed the IBC detection capabilities of a bioimpedance spectroscopy (BS) monitoring system that uses a novel functionalized introducer sheath. The device was tested in three large animal models of a clinical IBC. A 120-mL perivascular saline injection after sheath insertion, a slow continuous perivascular saline injection of 2.6 mL min⁻¹ of saline and a vessel-puncture model were tested. In each case, a significant change in normalized impedance was detected compared to the controls. This study provides evidence that a functionalized vascular access sheath using BS can detect an intraprocedural vascular access IBC. Clinical use of the device could help guide patient care by directly detecting vascular access complications early, thereby preventing unnecessary diagnostic scans to rule out the presence of IBCs.

• Catheterization
• catheters
• complications
• haemorrhage

Declaration of interest

The authors report no financial relationships or conflicts of interest regarding the content herein. The work described in this manuscript was funded through internal research funding through the Texas Heart Institute, which is currently a minority owner of Saranas, Inc.