Flexible BronchoscopyNCT05383729
Learning-curve-based Simulation Training for Bronchoscopic Intubation
A study testing learning-curve-based training modality and fixed-training-time training modality in people with Flexible Bronchoscopy and Simulation Training, run by Peking University People's Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Flexible Bronchoscopy, Simulation Training, Intubation Time
- What is being tested?
- learning-curve-based training modality and fixed-training-time training modality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesChina
- Study dates
- 25 May 2022to 26 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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. -
Who cannot join
- Those who have received standardized training will be excluded.
- -
Trial locations and contacts
2 sites in 1 country.
China2 sites
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Tibet autonomous region people's hospital
Lhasa, Tibet
About this study
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
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.
Read the 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.
- Conditions
- Flexible Bronchoscopy, Simulation Training, Intubation Time
- Being tested
- learning-curve-based training modality, fixed-training-time training modality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
learning-curve-based training modalityOther
It is an individual duration of simulation training that is based on the previous performance of FOB on a simulator.
fixed-training-time training modalityOther
It is a training duration of 1 hour which is the dominant duration of simulator training in previous studies.[1]
| Study group | Role | What they receive |
|---|---|---|
| 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] Receives: 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. Receives: Other: fixed-training-time training modality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Just after the completion of the intubation, in one minute
Secondary outcomes (5)
duration of the training
The total duration of the simulation training on a high-fidelity simulator
Measured: 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
The total number of procedures performing FOB on a high-fidelity simulator
Measured: From the training initiating to its ending, a sum will be calculated in 24 hours after the training
success rate of intubation
Successful intubation in patients
Measured: Just after the completion of the intubation, in one minute
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.
Measured: After the training, the scores will be acquired from the data storage of the simulators in 24 hours
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.
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start25 May 2022
- Primary completion26 Aug 2022
- Study completion26 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Flexible BronchoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multiple-center, randomized, single-blind, noninferiority study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tibet Autonomous Region People's Hospital
- Responsible party
- Principal investigator, Yi Feng, MD, Peking University People's Hospital
- Investigators
- Yi Feng, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383729
- Sponsor's protocol ID
- 2018PHB088
- Status last verified
- Oct 2022
- First submitted
- 11 May 2022
- Last updated
- 24 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30234669Jiang 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.
PubMed 29621098Chandra 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.
PubMed 19034097Naik 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.
PubMed 11506104Roh 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.
PubMed 33167909Mahmood 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.
PubMed 33849039
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05383729
- Acronym / sponsor ID
- 2018PHB088
- Conditions
- Flexible Bronchoscopy, Simulation Training, Intubation Time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Tibet Autonomous Region People's Hospital
- Study start
- 25 May 2022 (actual)
- Primary completion
- 26 Aug 2022 (actual)
- Study completion
- 26 Aug 2022 (actual)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a multiple-center, randomized, single-blind, noninferiority study.
| Arm | Type | Receives |
|---|---|---|
| new training | Experimental | Other: learning-curve-based training modalityIn 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] |
| reference training | Active comparator | Other: fixed-training-time training modalityIn this reference fixed-training-time training modality, participants will receive training with a high-fidelity simulator for 1h. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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. -
Key exclusion criteria (2 listed)
- Those who have received standardized training will be excluded.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| learning-curve-based training modalityIt is an individual duration of simulation training that is based on the previous performance of FOB on a simulator. | Other | new training |
| fixed-training-time training modalityIt is a training duration of 1 hour which is the dominant duration of simulator training in previous studies.[1] | Other | reference training |
Primary outcome
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.
5 secondary outcomes
duration of the training
Time frame: 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
Time frame: From the training initiating to its ending, a sum will be calculated in 24 hours after the training
success rate of intubation
Time frame: Just after the completion of the intubation, in one minute
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
performance of FOB intubation in patients
Time frame: One week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
- Background: PubMed 30234669Wong 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.
- Background: PubMed 29621098Jiang 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.
- Background: PubMed 19034097Chandra 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.
- Background: PubMed 11506104Naik 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.
- Background: PubMed 33167909Roh 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.
- Background: PubMed 33849039Mahmood 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.
- Individual participant dataSharing planned: No
Related trials for Flexible Bronchoscopy
Not yet recruiting
Midazolam Alone Versus Midazolam With Ketorolac for Sedation During Flexible Bronchoscopy.
Sedation and Analgesia Management in Patients Undergoing Flexible Bronchoscopy
Active, not recruiting
the Value of Flexible Bronchoscopy in the Neonatal Intensive Care Unit at Sohag University Hospitals
Study Including Neonates Who Underwent Flexible Fiberoptic Bronchoscopy in Last 10 Years at Sohag University Hospitals
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Feng principal investigator
Peking University People's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing learning-curve-based training modality and fixed-training-time training modality in people with Flexible Bronchoscopy and Simulation Training, run by Peking University People's Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to complete FOB intubation (time frame: Just after the completion of the intubation, in one minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05383729, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2022; AzTrials last refreshed its copy on 26 Oct 2026.