Increasing the precision of simulated percutaneous dilatational tracheostomy-a pilot prototype device development study

Percutaneous dilatational tracheostomy (PDT) is a bedside medical procedure which sites a new tracheostomy tube in the front of the neck. The critical first step is accurate placement of a needle through the neck tissues into the trachea. Misplacement occurs in around 5% of insertions, causing morbidity, mortality, and delays to recovery. We aimed to develop and evaluate a prototype medical device to improve precision of initial PDT-needle insertion. The Guidance for Tracheostomy (GiFT) system communicates the relative locations of intra-tracheal target sensor and PDT-needle sensor to the operator. In simulated "difficult neck" models, GiFT significantly improved accuracy (mean difference 10.0 mm, ANOVA p < 0.001) with ten untrained laboratory-based participants and ten experienced medical participants. GiFT resulted in slower time-to-target (mean difference 56.1 s, p < 0.001) than unguided attempts, considered clinically insignificant. Our proof-of-concept study highlights GiFT's potential to significantly improve PDT accuracy, reduce procedural complications and offer bedside PDT to more patients.