(1044) Automated Central Venous Catheterization With the CERTA System

Introduction:

Introduction:
Central venous catheter (CVC) placement is often necessary to provide key interventions for the critically ill. However, extensive training and experience are necessary to place these catheters. Even so, placement complication rates are 4 – 7 %. Automation of the catheter placement may allow safer, more reliable placement, with less training. We present here the results of the first human trial of the CERTA (Obvius Robotics) automated central line placement system.

Methods:

Methods:
The handheld CERTA system incorporates an ultrasound probe, vessel targeting software, a motorized needle vibrator and driver, a handle with controller buttons, and an 18 Gauge needle for vessel entry, as well as disposables for sterile technique. The system, essentially, allows targeting of a central vein with ultrasound, then automatically advances the access needle to the target, at the press of a button. A guide wire is manually placed through the needle into the vessel, and a standard CVC is placed over the guidewire (Seldinger tech). After extensive large animal model testing, the CERTA system was approved for a trial in humans at Sanitorio Italiano in Asuncion, Paraguay, by the facility Ethics in Research Committee.
17 patients had CVC placement attempted via CERTA. The primary indication for access was hemodialysis (16 patients). The other indication was for resuscitation. Catheter placement locations were right and left internal jugular, right and left subclavian and femoral veins.

Results: Results
All 17 patients had CVC successfully placed via the CERTA system. There were no insertion complications, to include bleeding or hematoma, local trauma to other structures, or pneumothorax. CERTA effectively allowed CVC placement in the major access points for CVCs. All but two patients had the catheter placed successfully on first attempt with the CERTA. Two patients required two attempts due to movement while placing the CVC.

Conclusions: Conclusion
The CERTA automated CVC placement device proved safe, reliable and efficient in this first human trial. The technology may enable CVC placement with significantly less training and experience.