Centrally inserted central catheter placement using a novel, handheld, image-guided, robotic device: Results of initial feasibility trial in patients.

Abstract

Background: Central venous access devices (CVADs) are an essential and widely used tool for the treatment of the critically ill, patients undergoing major surgery, and for many patients requiring hemodialysis. Automation of centrally inserted central catheters (CICCs) could potentially make CVAD placement safer, more effective, and more accessible. A new device that uses ultrasound image-guided, robotic needle placement, in addition to traditional Seldinger technique, to place a CICC is described.

Objective: The device was used in a small, first-in-human, trial for placing non-tunneled hemodialysis catheters (NTHDCs), in order to determine feasibility of clinical use.

Methods: Consecutive patients requiring a NTHDC, at one institution, over a 48 h period, were recruited to consent to placing the catheter by the device. Observations of safety, efficacy, and efficiency of the procedure were recorded.

Results: There were 19 catheter placement attempts in 17 patients. All placements were successful (100%). The first placement attempt was successful in 16/19 catheterizations (84%). Two catheterizations required two attempts and one required three attempts. There were no complications for any catheterization. The device provided rapid access to the target central vein and required relatively little training time for operators.

Conclusions: The study demonstrates the feasibility for clinical application of a novel central venous access robotic device.