Validation of a 3D‐Printed Percutaneous Injection Laryngoplasty Simulator: A Randomized Controlled Trial

Objective Simulation may be a valuable tool in training laryngology office procedures on unsedated patients. However, no studies have examined whether existing awake procedure simulators improve trainee performance in laryngology. Our objective was to evaluate the transfer validity of a previously published 3D-printed laryngeal simulator in improving percutaneous injection laryngoplasty (PIL) competency compared with conventional educational materials with a single-blinded randomized controlled trial. Methods Otolaryngology residents with fewer than 10 PIL procedures in their case logs were recruited. A pretraining survey was administered to participants to evaluate baseline procedure-specific knowledge and confidence. The participants underwent block randomization by postgraduate year to receive conventional educational materials either with or without additional training with a 3D-printed laryngeal simulator. Participants performed PIL on an anatomically distinct laryngeal model via trans-thyrohyoid and trans-cricothyroid approaches. Endoscopic and external performance recordings were de-identified and evaluated by two blinded laryngologists using an objective structured assessment of technical skill scale and PIL-specific checklist. Results Twenty residents completed testing. Baseline characteristics demonstrate no significant differences in confidence level or PIL experience between groups. Senior residents receiving simulator training had significantly better respect for tissue during the trans-thyrohyoid approach compared with control (p < 0.0005). There were no significant differences in performance for junior residents. Conclusions In this first transfer validity study of a simulator for office awake procedure in laryngology, we found that a previously described low-cost, high-fidelity 3D-printed PIL simulator improved performance of PIL amongst senior otolaryngology residents, suggesting this accessible model may be a valuable educational adjunct for advanced trainees to practice PIL. Level of Evidence N/A Laryngoscope, 2023