Flexible Bronchoscopy, Intubation Time, Simulation Training
Conditions
Brief 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.
Interventions
OTHERlearning-curve-based training modality
It is an individual duration of simulation training that is based on the previous performance of FOB on a simulator.
OTHERfixed-training-time training modality
It is a training duration of 1 hour which is the dominant duration of simulator training in previous studies.\[1\]
Sponsors
Tibet Autonomous Region People's Hospital
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
This is a multiple-center, randomized, single-blind, noninferiority study.
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time to complete FOB intubation | Just after the completion of the intubation, in one minute | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| duration of the training | From the training initiating to its ending, a sum will be calculated in 24 hours after the training | The total duration of the simulation training on a high-fidelity simulator |
| total number of procedures on the simulators | From the training initiating to its ending, a sum will be calculated in 24 hours after the training | The total number of procedures performing FOB on a high-fidelity simulator |
| success rate of intubation | Just after the completion of the intubation, in one minute | Successful intubation in patients |
| performance of FOB intubation on simulators | After the training, the scores will be acquired from the data storage of the simulators in 24 hours | 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. |
| performance of FOB intubation in patients | One week | 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. |
Countries
China
Outcome results
None listed