Learning-curve-based Simulation Training for Bronchoscopic Intubation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-25

Study Completion Date

2022-08-26

Brief Summary

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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.

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Detailed Description

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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

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Flexible Bronchoscopy Simulation Training Intubation Time

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a multiple-center, randomized, single-blind, noninferiority study.

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

The group assignments will be concealed from the collectors who will record the intubation data in patients. Anonymized recordings will be sent to an independent assessor who assesses the performance of FOB intubation in patients.

Study Groups

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new training

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.\[2\]

Group Type EXPERIMENTAL

learning-curve-based training modality

Intervention Type OTHER

It is an individual duration of simulation training that is based on the previous performance of FOB on a simulator.

reference training

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

Group Type ACTIVE_COMPARATOR

fixed-training-time training modality

Intervention Type OTHER

It is a training duration of 1 hour which is the dominant duration of simulator training in previous studies.\[1\]

Interventions

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learning-curve-based training modality

It is an individual duration of simulation training that is based on the previous performance of FOB on a simulator.

Intervention Type OTHER

fixed-training-time training modality

It is a training duration of 1 hour which is the dominant duration of simulator training in previous studies.\[1\]

Intervention Type OTHER

Eligibility Criteria

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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. -