Ciaglia Blue Dolphin: a new technique for percutaneous tracheostomy using balloon dilation

Introduction

Percutaneous tracheostomy (PcT) has reached a high level of safety; however, significant perioperative complications still occur. The most feared complication is posterior tracheal wall injury during insertion of the dilational device into the trachea applying downward pressure. Ciaglia Blue Dolphin (CBD) is a new technique for PcT using radial balloon dilation, thereby eliminating downward pressure during insertion and dilation.

Methods

An observational, clinical trial was conducted in 20 adult ICU patients undergoing elective PcT with the CBD technique (Cook Inc., Bloomington, IN, USA). After a 15 mm skin incision, tracheal puncture, and predilation of the puncture channel with a 14 F punch dilator, a balloon-cannula apparatus was passed over a guidewire until the tip of the balloon mounted at the distal end of the apparatus was seen in the trachea. The balloon was inflated with saline solution to 11 atm for a few seconds, then deflated, and the 8.0 mm ID tracheostomy tube preloaded onto a customized stylet, which formed the proximal portion of the apparatus, was placed by advancing the entire apparatus further into the trachea. The apparatus and guidewire were then removed, leaving only the cannula in place.

Results

Twenty patients underwent CBD PcT under bronchoscopic control. All procedures were successfully completed in a mean time of 3.8 ± 1.7 minutes. Even though six patients were under continuous therapeutic anticoagulation therapy, blood loss was classified as 'none' (n = 14), 'marginal' (n = 5), or 'moderate' (n = 1). In the latter patient, bleeding occurred from a subcutaneous vein, but ceased without further intervention once the tracheostomy tube was in place. No other complications of either medical or technical nature were noted.

Conclusion

Based on the data of this first clinical report, the new CBD device allows for quick, reliable, and safe dilation and subsequent cannula placement with one single apparatus. Even though the operators had no previous experience with CBD, no complications were noted. Randomized trials need now to be conducted to confirm the promising results of our study and to determine both advantages and disadvantages of the CBD technique when compared with other techniques of PcT.