Translaryngeal Tracheostomy Needle Introducer: a simple device to improve safety and reduce complications during Fantoni's translaryngeal tracheostomy procedure: trial on human cadavers

Background: Percutaneous dilatational tracheostomy (PDT) is the most frequently performed procedure in patients requiring prolonged mechanical ventilation. A crucial step in such procedures is needle insertion into the trachea. To simplify this procedure and increase its safety, we developed a new device, the translaryngeal Tracheostomy Needle Introducer (tTNI), for use with Fantoni’s method. This cadaver study was designed to assess the performance of the tTNI on human anatomy. Methods: We tested the tTNI in a cadaver laboratory; the operators included two experts trained in PDT and three without specific training in the procedure. We performed 58 needle insertion attempts on 13 cadavers. We compared the tTNI technique with the standard needle insertion approach using external landmarks. We recorded the number of attempts needed to optimise needle insertion, time required in seconds, final position of the needle and complications related to needle insertion. Results: tTNI use resulted in fewer puncture attempts (1.91 ± 1.34 vs. 1.19 ± 0.5, p < 0.001), less time (36.8 ± 51.6 s vs. 13.14 ± 15.57 s, p < 0,001) and increased precision on the first puncture (18.87 ± 25.38° vs. 7.5 ± 12.95°, p < 0,005). We did not observe any complication with tTNI use, whereas complications found using the standard method were in line with the literature. Conclusions: The tTNI is a device that simplifies needle insertion by enhancing the accuracy of insertion with fewer attempts and higher precision, even when used by less experienced operators. Clinical testing is required to evaluate the device performance in patients.