Learning-curve-based Simulation Training for Bronchoscopic Intubation

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05383729
Study type	Interventional
Source	Peking University People's Hospital
Contact
Status	Completed
Phase	N/A
Start date	May 25, 2022
Completion date	August 26, 2022

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.