Clinical Trials Directory

Trials / Completed

CompletedNCT05383729

Learning-curve-based Simulation Training for Bronchoscopic Intubation

The Effect on Bronchoscopic-guided Intubation Time in Patients of Learning-curve-based Simulation Training Modality v.s. Fixed-training-time Simulation Training Modality: a Noninferiority Randomized Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
32 (actual)
Sponsor
Peking University People's Hospital · Academic / Other
Sex
All
Age
Healthy volunteers
Accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
OTHERlearning-curve-based training modalityIt is an individual duration of simulation training that is based on the previous performance of FOB on a simulator.
OTHERfixed-training-time training modalityIt is a training duration of 1 hour which is the dominant duration of simulator training in previous studies.\[1\]

Timeline

Start date
2022-05-25
Primary completion
2022-08-26
Completion
2022-08-26
First posted
2022-05-20
Last updated
2022-10-24

Locations

2 sites across 1 country: China

Source: ClinicalTrials.gov record NCT05383729. Inclusion in this directory is not an endorsement.