Simulator TrainingNCT05248347
An Efficacy of Simulator Training for Fiberbronchoscopy in Intensivists
A study testing Bronchoscopy training simulator LM-092 (Koken Co., Ltd, Tokyo, Japan) and The BRONCH Mentor (Simbionix, GI-Bronch Mentor, USA) in people with Simulator Training, run by Southeast University, China at 1 site in China.
Trial summary
We evaluated the effects of different fiberbronchoscopy training in how to teach and assess performance. Resident participants with no experience of fiberbronchoscopy, and doctors with little clinical experience with fiberbronchoscopy were eligible for the study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Simulator Training
- What is being tested?
- Bronchoscopy training simulator LM-092 (Koken Co., Ltd, Tokyo, Japan) and The BRONCH Mentor (Simbionix, GI-Bronch Mentor, USA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to Jun 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Doctors with little experience of fiberbronchoscopy
Who cannot join
- Resident participants who can not complete the study.
- Resident participants who can not pass the theroy examination.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing Zhongda Hospital, Southeast University
Nanjing, Jiangsu, 210000
Yanjie Zhang, 8617854236918, 220214274@seu.edu.com
Jingyuan Xu, M.D., 862586232550, xujingyuanmail@163.com
About this study
We evaluated the effects of different fiberbronchoscopy training in how to teach and assess performance. Resident participants with no experience of fiberbronchoscopy, and doctors with little clinical experience with fiberbronchoscopy were eligible for the study.
Read the detailed description
Participants who passed the theory test were enrolled in the study, and two training simulators for fiberbronchoscopy were used. After randomization, participants were enrolled in Group A (Bronchoscopy training simulator LM-092 )and Group B(The BRONCH Mentor). The test will be taken after practice at the appropriate time.
- Conditions
- Simulator Training
- Being tested
- Bronchoscopy training simulator LM-092 (Koken Co., Ltd, Tokyo, Japan), The BRONCH Mentor (Simbionix, GI-Bronch Mentor, USA)
- Keywords
- Fiberbronchoscopy, Simulation, Assessment, Validity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoscopy training simulator LM-092 (Koken Co., Ltd, Tokyo, Japan)Device
Participants who passed the theory test and was enrolled in this group will use this device to practice. After the appropriate time of practice, the test will be taken to evaluate the efficacy.
The BRONCH Mentor (Simbionix, GI-Bronch Mentor, USA)Device
Participants who passed the theory test and was enrolled in this group will use this device to practice. After the appropriate time of practice, the test will be taken to evaluate the efficacy.
| Study group | Role | What they receive |
|---|---|---|
| Bronchoscopy training simulator | Active comparator | Bronchoscopy training simulator LM-092 (Koken Co., Ltd, Tokyo, Japan) was used to train the participants. Receives: Device: Bronchoscopy training simulator LM-092 (Koken Co., Ltd, Tokyo, Japan) |
| The BRONCH Mentor | Experimental | Group B: The BRONCH Mentor (Simbionix, GI-Bronch Mentor, USA) was used. Receives: Device: The BRONCH Mentor (Simbionix, GI-Bronch Mentor, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Final score for examination by Bronchoscopy training simulator
Final score of manipulation, orientation, anatomy and actual operation
Measured: through study completion, an average of 3 months
Secondary outcomes (4)
% time at mid-lumen for fiberbronchoscopy manipulation by Bronchoscopy training simulator
% time at mid-lumen for fiberbronchoscopy manipulation by Bronchoscopy training simulator
Measured: through study completion, an average of 3 months
% time at mid-lumen
% time at mid-lumen
Measured: through study completion, an average of 3 months
% time at mid-lumen for fiberbronchoscopy manipulation
% time at mid-lumen for fiberbronchoscopy manipulation
Measured: through study completion, an average of 3 months
Total wall hits for fiberbronchoscopy manipulation by Bronchoscopy training simulator
Total wall hits for fiberbronchoscopy manipulation by Bronchoscopy training simulator
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start1 Jan 2022
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Simulator TrainingStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingyuan,Xu, Southeast University, China
- Investigators
- Jingyuan Xu, M.D., Study director, Southeast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248347
- Sponsor's protocol ID
- 20220116ZDSYZYJ
- Status last verified
- Feb 2022
- First submitted
- 9 Feb 2022
- Last updated
- 21 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Efficacy of Simulator Training for Fiberbronchoscopy in Intensivists
- ClinicalTrials.gov ID
- NCT05248347
- Acronym / sponsor ID
- 20220116ZDSYZYJ
- Conditions
- Simulator Training
- Keywords
- Fiberbronchoscopy, Simulation, Assessment, Validity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 21 Feb 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.
We evaluated the effects of different fiberbronchoscopy training in how to teach and assess performance. Resident participants with no experience of fiberbronchoscopy, and doctors with little clinical experience with fiberbronchoscopy were eligible for the study.
Detailed description
Participants who passed the theory test were enrolled in the study, and two training simulators for fiberbronchoscopy were used. After randomization, participants were enrolled in Group A (Bronchoscopy training simulator LM-092 )and Group B(The BRONCH Mentor). The test will be taken after practice at the appropriate time.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bronchoscopy training simulator | Active comparator | Device: Bronchoscopy training simulator LM-092 (Koken Co., Ltd, Tokyo, Japan)Bronchoscopy training simulator LM-092 (Koken Co., Ltd, Tokyo, Japan) was used to train the participants. |
| The BRONCH Mentor | Experimental | Device: The BRONCH Mentor (Simbionix, GI-Bronch Mentor, USA)Group B: The BRONCH Mentor (Simbionix, GI-Bronch Mentor, USA) was used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Doctors with little experience of fiberbronchoscopy
Key exclusion criteria (2 listed)
- Resident participants who can not complete the study.
- Resident participants who can not pass the theroy examination.
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 |
|---|---|---|
| Bronchoscopy training simulator LM-092 (Koken Co., Ltd, Tokyo, Japan)Participants who passed the theory test and was enrolled in this group will use this device to practice. After the appropriate time of practice, the test will be taken to evaluate the efficacy. | Device | Bronchoscopy training simulator |
| The BRONCH Mentor (Simbionix, GI-Bronch Mentor, USA)Participants who passed the theory test and was enrolled in this group will use this device to practice. After the appropriate time of practice, the test will be taken to evaluate the efficacy. | Device | The BRONCH Mentor |
Primary outcome
Final score for examination by Bronchoscopy training simulator
Time frame: through study completion, an average of 3 months
Final score of manipulation, orientation, anatomy and actual operation
4 secondary outcomes
% time at mid-lumen for fiberbronchoscopy manipulation by Bronchoscopy training simulator
Time frame: through study completion, an average of 3 months
% time at mid-lumen
Time frame: through study completion, an average of 3 months
% time at mid-lumen for fiberbronchoscopy manipulation
Time frame: through study completion, an average of 3 months
Total wall hits for fiberbronchoscopy manipulation by Bronchoscopy training simulator
Time frame: through study completion, an average of 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
- Individual participant dataSharing planned: Undecided
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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.
Jingyuan Xu, M.D. study director
Southeast University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchoscopy training simulator LM-092 (Koken Co., Ltd, Tokyo, Japan) and The BRONCH Mentor (Simbionix, GI-Bronch Mentor, USA) in people with Simulator Training, run by Southeast University, China at 1 site 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 1 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: status not confirmed, as of the sponsor's last update on 21 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Final score for examination by Bronchoscopy training simulator (time frame: through study completion, an average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2022.