Simulation Training Clinical Trial
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
NCT number | NCT05383729 |
Other study ID # | 2018PHB088 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 25, 2022 |
Est. completion date | August 26, 2022 |
Verified date | October 2022 |
Source | Peking University People's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | August 26, 2022 |
Est. primary completion date | August 26, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | 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. - |
Country | Name | City | State |
---|---|---|---|
China | Peking University People's Hospital | Beijing | Beijing |
China | Tibet autonomous region people's hospital | Lhasa | Tibet |
Lead Sponsor | Collaborator |
---|---|
Peking University People's Hospital | Tibet Autonomous Region People's Hospital |
China,
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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | duration of the training | The total duration of the simulation training on a high-fidelity simulator | From the training initiating to its ending, a sum will be calculated in 24 hours after the training | |
Secondary | total number of procedures on the simulators | The total number of procedures performing FOB on a high-fidelity simulator | From the training initiating to its ending, a sum will be calculated in 24 hours after the training | |
Secondary | success rate of intubation | Successful intubation in patients | Just after the completion of the intubation, in one minute | |
Secondary | performance of FOB intubation on simulators | 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. | After the training, the scores will be acquired from the data storage of the simulators in 24 hours | |
Secondary | performance of FOB intubation in patients | 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. | One week |
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