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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- time to complete FOB intubation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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. -
排除标准
- •Those who have received standardized training will be excluded.
研究组 & 干预措施
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]
干预措施: learning-curve-based training modality (Other)
reference training
In this reference fixed-training-time training modality, participants will receive training with a high-fidelity simulator for 1h.
干预措施: fixed-training-time training modality (Other)
结局指标
主要结局
time to complete FOB intubation
时间窗: 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.
次要结局
- 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)
- success rate of intubation(Just after the completion of the intubation, in one minute)
- performance of FOB intubation in patients(One week)
- duration of the training(From the training initiating to its ending, a sum will be calculated in 24 hours after the training)
- performance of FOB intubation on simulators(After the training, the scores will be acquired from the data storage of the simulators in 24 hours)
研究者
Yi Feng, MD
Chair of Department of Anesthesiology
Peking University People's Hospital