RESUMEN
BACKGROUND: Percutaneous tracheostomy is frequently performed in intensive care units in patients who require prolonged mechanical ventilation. The first crucial step for the physician in these procedures is the precise needle insertion into the trachea. The primary aim of this technical note was to test the new filament and share our experiences in the implementation of the new device. The secondary aim was to show how a physician with basic training in computer-aided design and three-dimensional (3D) printing could independently create useful devices for clinical practice. METHODS: To simplify this referred clinical procedure and increase its safety, 3D printing and a new medical filament were used to develop a new translaryngeal Tracheostomy Needle Introducer (tTNI) for use in conjunction with the Fantoni's method of percutaneous tracheostomy. The tTNI is composed of three parts: a support to fit on the rigid endotracheal tube of the Fantoni kit, an external particular shaped arm, and an introducer for the needle. The latest version of the device used a new filament based on a polyester matrix certified for skin contact that was sterilizable in a standard autoclave. Post-printing, minor technical interventions were required to correct small material deformities. CONCLUSIONS: Our experiences with the thread and the technical features of the material were reported herein in conjunction with some suggestions on how to solve the most frequently encountered problems. The 3D printing technique allows physicians to directly manage the prototyping process of new medical devices, making this process completely independent. The speed of the prototyping process and the testing of each piece allow faster creation of a prototype than with traditional industrial methods. Finally, the new biomedical filaments offer endless possibilities of creation and modelling.
RESUMEN
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.
RESUMEN
The original version of this article unfortunately contained a mistake. The presentation of Table 1 was incorrect. The corrected Table 1 is given below.