Learning-curve-based Simulation Training for Bronchoscopic Intubation

NCT05383729 | Completed

• 1 other identifier: 2018PHB088
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

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.

Conditions

Flexible Bronchoscopy; Simulation Training; Intubation Time

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• duration of the training

  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

  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 on 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

  One week

Study Arms (2)

new training

EXPERIMENTAL

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

reference training

ACTIVE COMPARATOR

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

Interventions

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.

new training

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.\[1\]

reference training

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• Those who have received standardized training will be excluded.

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Tibet Autonomous Region People's Hospital: collaborator

Study Sites (2)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Tibet autonomous region people's hospital

Lhasa, Tibet, China

Location

Related Publications (6)

• 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.

  PMID: 30234669 BACKGROUND

• 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.

  PMID: 29621098 BACKGROUND

• Chandra DB, Savoldelli GL, Joo HS, Weiss ID, Naik VN. Fiberoptic oral intubation: the effect of model fidelity on training for transfer to patient care. Anesthesiology. 2008 Dec;109(6):1007-13. doi: 10.1097/ALN.0b013e31818d6c3c.

  PMID: 19034097 BACKGROUND

• 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.

  PMID: 11506104 BACKGROUND

• 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.

  PMID: 33167909 BACKGROUND

• 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.

  PMID: 33849039 BACKGROUND

Study Officials

• Yi Feng

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Department of Anesthesiology

Model Details: This is a multiple-center, randomized, single-blind, noninferiority study.

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 20, 2022
• Study Start: May 25, 2022
• Primary Completion: August 26, 2022
• Study Completion: August 26, 2022
• Last Updated: October 24, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)