Learning-curve-based Simulation Training for Bronchoscopic Intubation

Study Overview
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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.

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.

Official Title
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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

Conditions
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Flexible Bronchoscopy, Simulation Training, Intubation Time

Intervention / Treatment
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* Other: learning-curve-based training modality
* Other: fixed-training-time training modality


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: anesthesia residents or interns at Peking University People's Hospital, Beijing, China or Tibet Autonomous Region People's Hospital, Lhasa, Tibet, China; have performed less than five FOB intubations in patients; consent to this study. - Exclusion Criteria: Those who have received standardized training will be excluded. -
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a multiple-center, randomized, single-blind, noninferiority study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: new training<br>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] | Other: learning-curve-based training modality<br>* It is an individual duration of simulation training that is based on the previous performance of FOB on a simulator.<br>|
| Active Comparator: reference training<br>In this reference fixed-training-time training modality, participants will receive training with a high-fidelity simulator for 1h. | Other: fixed-training-time training modality<br>* It is a training duration of 1 hour which is the dominant duration of simulator training in previous studies.[1]<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to complete FOB intubation | It is a noninferiority outcome. After training, one FOB intubation will be performed within one week. Patients scheduled for elective surgery which requires tracheal intubation will be included. Those with an anticipated or known difficult airway or American Society of Anesthesiology (ASA) Physical Status Classification equaling or exceeding III will be excluded. General anesthesia is performed by the attending anesthetists who does not involve in this study. Patients are mask ventilated for 2min after induction. Assistance with jaw thrust is provided during intubation. Criteria for termination of intubation are SpO 2 of 90% or less, airway tissue trauma during the intubation attempt, attempt time exceeding 4min, or the anesthetist in the charge being unwilling to continue. | Just after the completion of the intubation, in one minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of the training | The total duration of the simulation training on a high-fidelity simulator | From the training initiating to its ending, a sum will be calculated in 24 hours after the training | 
| total number of procedures on the simulators | The total number of procedures performing FOB on a high-fidelity simulator | From the training initiating to its ending, a sum will be calculated in 24 hours after the training | 
| success rate of intubation | Successful intubation in patients | Just after the completion of the intubation, in one minute | 
| performance of FOB intubation on simulators | The last 3 intubations on simulators will be assessed. The simulator assesses the performance based on the validated five-point global rating scale (GRS) of fiberoptic bronchoscope manipulation, which is standardized to a 100-scale score (0=worst, 100=best) automatically by the simulators. | After the training, the scores will be acquired from the data storage of the simulators in 24 hours | 
| performance of FOB intubation in patients | The intubation will be recorded and sent to an assessor, who will assess the performance using the five-point global rating scale (GRS, 8 items, 5 points each, up to a total of 40 points, 0=worst, 40=best) of fiberoptic bronchoscope manipulation in one week. To unify the results, the GRS will be standardized to a 100-scale score (0=worst, 100=best) in the analysis. | One week |