Study design and development of a new technique for percutaneous dilatational tracheostomy called G-Trach.

Tracheostomies are currently used for airway management in patients requiring long-term respiratory assistance, the dilatational percutaneous technique being a valuable alternative to traditional surgical \u2018open\u2019 techniques. In this study, we developed a novel dilatational percutaneous tracheostomy device using a balloon dilator with a particular innovative shape (G-Trach). We tested, this device, at the Autonomous University of Barcelona Veterinary Institute, on eight pigs (weighing 20\u201340 kg) which were anaesthetised and underwent tracheostomy using the novel G-Trach technique. The mean (SD) procedure time was 2.63(0.64) min from tracheal puncture to ventilation through the tracheostomy tube; the mean (SD) time from positioning the dilator balloon to introducing the cannula was 0.71(0.38) min. Vital functions and oxygen saturation remained constant throughout the procedures. Post-mortem examinations did not reveal any tracheal injury. Thus, the G-Trach seems to be a safe and easy new dilatational percutaneous technique for forming tracheostomies. A preliminary study on humans (six patients) confirmed the results of the study on pigs and has shown the need of some changes to the device to improve the transition between the balloon and the distal part of the tube tracheotomy. A new patent request has therefore been submitted wherein the profile of the balloon (shaped as an inverted cone) is prolonged so as to wrap the tip of the tracheostomy tube