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Completed

NCT Number: NCT05383729

Learning-curve-based Simulation Training for Bronchoscopic Intubation

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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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University People's Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

-

Treatment and study plan

learning-curve-based training modality

Other

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

fixed-training-time training modality

Other

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

Primary outcomes

  1. time to complete FOB intubation

    Time frame: 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 outcomes

  1. duration of the training

    Time frame: 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

  2. total number of procedures on the simulators

    Time frame: 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

  3. success rate of intubation

    Time frame: Just after the completion of the intubation, in one minute

    Successful intubation in patients

  4. performance of FOB intubation on simulators

    Time frame: 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.

  5. performance of FOB intubation in patients

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Collaborators

  • Tibet Autonomous Region People's Hospital

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 20, 2022
Registry last updated
Oct 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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