Clinical trial NCT05383729: Learning-curve-based Simulation Training for Bronchoscopic Intubation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Flexible Bronchoscopy
Simulation Training
Intubation Time
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Tibet Autonomous Region People's Hospital
First posted: 2022-05-20
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a multiple-center, randomized, single-blind, noninferiority study.
Primary purpose: OTHER

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.

Eligibility criteria: 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.

-

Primary outcomes:
measure: time to complete FOB intubation
timeFrame: Just after the completion of the intubation, in one minute
Secondary outcomes:
measure: duration of the training
timeFrame: From the training initiating to its ending, a sum will be calculated in 24 hours after the training
measure: total number of procedures on the simulators
timeFrame: From the training initiating to its ending, a sum will be calculated in 24 hours after the training
measure: success rate of intubation
timeFrame: Just after the completion of the intubation, in one minute
measure: performance of FOB intubation on simulators
timeFrame: After the training, the scores will be acquired from the data storage of the simulators in 24 hours
measure: performance of FOB intubation in patients
timeFrame: One week
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Lhasa
country: China
facility: Tibet autonomous region people's hospital
state: Tibet
Study officials:
affiliation: Peking University People's Hospital
name: Yi Feng
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wong DT, Mehta A, Singh KP, Leong SM, Ooi A, Niazi A, You-Ten E, Okrainec A, Patel R, Singh M, Wong J. The effect of virtual reality bronchoscopy simulator training on performance of bronchoscopic-guided intubation in patients: A randomised controlled trial. Eur J Anaesthesiol. 2019 Mar;36(3):227-233. doi: 10.1097/EJA.0000000000000890.
citation: Jiang B, Ju H, Zhao Y, Yao L, Feng Y. Comparison of the Efficacy and Efficiency of the Use of Virtual Reality Simulation With High-Fidelity Mannequins for Simulation-Based Training of Fiberoptic Bronchoscope Manipulation. Simul Healthc. 2018 Apr;13(2):83-87. doi: 10.1097/SIH.0000000000000299.
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citation: Naik VN, Matsumoto ED, Houston PL, Hamstra SJ, Yeung RY, Mallon JS, Martire TM. Fiberoptic orotracheal intubation on anesthetized patients: do manipulation skills learned on a simple model transfer into the operating room? Anesthesiology. 2001 Aug;95(2):343-8. doi: 10.1097/00000542-200108000-00014.
citation: Roh GU, Kang JG, Han JY, Chang CH. Utility of oxygen insufflation through working channel during fiberoptic intubation in apneic patients: a prospective randomized controlled study. BMC Anesthesiol. 2020 Nov 10;20(1):282. doi: 10.1186/s12871-020-01201-9.
citation: Mahmood K, Wahidi MM, Shepherd RW, Argento AC, Yarmus LB, Lee H, Shojaee S, Berkowitz DM, Van Nostrand K, Lamb CR, Shofer SL, Gao J, Davoudi M. Variable Learning Curve of Basic Rigid Bronchoscopy in Trainees. Respiration. 2021;100(6):530-537. doi: 10.1159/000514627. Epub 2021 Apr 13.