A Novel, Adaptable Laryngeal Mask to Facilitate a Percutaneous Dilatational Tracheostomy: Proof-of-Concept Prototype Demonstration on a Mannequin Model and Cadaver.

Abstract

Most percutaneous dilatational tracheostomy (PDT) mortalities result from airway-related complications. Improved airway pressure management and gas delivery are targets for innovation. This study describes an adaptable laryngeal mask (ALM) designed to remove the bronchoscope from the endotracheal tube (ETT) and place it in a separate lumen. Airflow and device efficacy were evaluated during PDTs with an ALM on mannequins and cadavers, respectively. Procedures were completed by a single physician using an 8.0 mm ETT and the Ciaglia Blue Rhino method on simulation mannequins (TruCorp AirSim Traci) and fresh-frozen cadavers. Mannequin simulation tested the respiratory capabilities of an ALM utilizing a BioPac spirometer and a Maquet Servo ventilator. Qualitative analysis on device efficacy was performed on 2 fresh-frozen cadavers (1 male, 1 female). Preliminary ventilation testing on a PDT-able mannequin using the ALM showed an increase in airflow reaching the lungs compared with a deflated ETT. During mannequin and cadaver testing, the ALM was placed over the in situ ETT effectively, thereby removing the bronchoscope from the ETT while maintaining a continuous visual of the incision site. Both mannequin and cadaveric testing using an ALM enabled a single physician to safely perform the PDT procedure with minimal assistance. Initial testing using an ALM during PDT on mannequins and cadavers showed an improvement in airflow and the removal of the bronchoscope from the ETT, respectively. Further studies using the ALM in a patient population compared with standard techniques would be useful.