Learning-curve-based Simulation Training for Bronchoscopic Intubation

Peking University

Status: Completed

Conditions: Simulation Training; Flexible Bronchoscopy; Intubation Time

Treatments: Other: learning-curve-based training modality; Other: fixed-training-time training modality

Study type: Interventional

Funder types: Other

Identifiers

NCT05383729

2018PHB088

Details and patient eligibility

About

This study aims to determine whether a new learning-curve-based simulation training modality could contribute to a noninferiority regarding bronchoscopic-guided intubation time in patients compared with the reference fixed-training-time simulation training modality, albeit with less training time.

Full description

Questions remain concerning the optimal duration of simulator training for flexible optical bronchoscopic (FOB) intubation. The investigators' previous study demonstrated that an exponential curve could fit the learning curve of FOB intubation training on a high-fidelity simulator after logarithmical transformation of the procedure time. In brief, trainees could achieve a plateau of the learning curve after several procedures, i.e., further training might provide only negligible progress. According to the investigators' preliminary study, the training time for the majority might be less than one hour which is the dominant duration of simulator training in previous studies. By generating a learning curve from the initial several procedures on a simulator, it is possible to predict when a trainee could grow saturated individually. It is hypothesized that this new learning-curve-based training modality could contribute to non-inferior FOB intubation time in patients compared with the reference fixed-training-time (1 hour) training modality, albeit with less training time. The noninferiority margin is defined according to the reported FOB intubation time and the training effect in previous studies. Moreover, it is plausible that this new training modality might even present a higher success rate and better performance of FOB intubation, considering each trainee following the new training has to achieve the individual goal that precludes an outlier from failing to have enough training that might occur in reference fixed-training-time training.

Enrollment: 32 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. anesthesia residents or interns at Peking University People's Hospital, Beijing, China or Tibet Autonomous Region People's Hospital, Lhasa, Tibet, China;
2. have performed less than five FOB intubations in patients;
3. consent to this study. -

Exclusion criteria

Those who have received standardized training will be excluded.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

new training

Experimental group

Description:

In this new learning-curve-based training modality, after participants complete 16 procedures on a high-fidelity simulator, an individual learning curve will be generated using the previously validated equation: ln⁡(γ)=γ_0 e\^(-kn)+γ_∞ where γ is procedure time, n is previous experiences.\[2\] Other parameters and their 95% Confidence Interval (CI) can be obtained after curve fitting. And e\^(γ_∞ ) is the asymptote of this curve. Then the trainees will continue the training. If the following procedure time falls into the 95% CI of the asymptote for three consecutive times,\[6\] the individual training goal is considered achieved.\[2\]

Treatment:

Other: learning-curve-based training modality

reference training

Active Comparator group

Description:

In this reference fixed-training-time training modality, participants will receive training with a high-fidelity simulator for 1h.

Treatment:

Other: fixed-training-time training modality