Optimal Duration of High-Fidelity Simulator Training for Bronchoscope-Guided Intubation: A Noninferiority Randomized Trial.

ABSTRACT

INTRODUCTION: The optimal simulator training duration for flexible optical bronchoscopic (FOB) intubation is unknown. This study aimed to determine whether a learning curve-based training modality was noninferior to a fixed training time modality in terms of clinical FOB intubation time. METHODS: This multicenter, randomized, noninferiority study was conducted from May to August 2022. Anesthesiology residents or interns were enrolled. Eligible participants were randomized in a 11 ratio to receive new learning curve-based simulator training (individualized training time based on performance, group New) or reference fixed training time simulator training (1 hour, group Reference). The primary outcome was the time to complete FOB intubation in patients, which was defined as the time from the introduction of the FOB into the mouth until the first capnography visualization. The margin for detecting clinical significance was defined as 10 seconds. RESULTS: A total of 32 participants were included in the analysis (16 in each group). All trainees successfully intubated the patients. The mean intubation time (95% confidence interval [CI]) was 81.9 (65.7-98.1) seconds in group New and 97.0 (77.4-116.6) seconds in group Reference. The upper bound of the 1-sided 97.5% CI for the mean difference of clinical intubation time between groups was 9.3 seconds. Noninferiority was claimed. The mean duration of the training in group New was 28.4 (95% CI, 23.5-33.4) minutes. The total number of training procedures on simulators in group New was significantly less than that in group Reference (P < 0.01). CONCLUSIONS: The clinical FOB intubation time in group New was noninferior to that in group Reference.