Difficult AirwayNCT05327842
Evaluation of a Flexible Videoscope Training Simulator
A study testing New training simulator and Traditional simulator in people with Difficult Airway, run by Tongji Hospital at 1 site in China.
Trial summary
Flexible bronchoscope or videoscope plays important roles in managing difficult airway. But this technique is time-consuming and very difficult to learn for novices. The investigators design a simple training simulator to help them master this technique. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Difficult Airway
- What is being tested?
- New training simulator and Traditional simulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2022to 2 Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Resident or Medical student
- Willing to participate to the study
- Consent to evaluate the measured data
Who cannot join
- experienced anesthetists
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Flexible Videoscope Training Simulator: a Randomized, Controlled, Simulation Teaching Study
Flexible bronchoscope or videoscope plays important roles in managing difficult airway. But this technique is time-consuming and very difficult to learn for novices. The investigators design a simple training simulator to help them master this technique.
Read the detailed description
In this study, residents without operational experience will be recruited. The training effect of the new simulator will be evaluated by comparison with traditional simulation teaching. Participants will receive training with the new simulator or traditional method for 1hour, and then they perform intubation with flexible videoscope in a simulated difficult airway model. The insertion time and success rate will be recorded. Last, they will complete the questionnaire.
- Conditions
- Difficult Airway
- Being tested
- New training simulator, Traditional simulator
- Keywords
- intubation, flexible bronchoscope, difficult airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New training simulatorDevice
Participants receive training with new simulator
Traditional simulatorDevice
Participants receive traditional training
| Study group | Role | What they receive |
|---|---|---|
| New training simulator | Experimental | Participants received training with new simulator Receives: Device: New training simulator |
| Traditional method | Active comparator | Participants received traditional training Receives: Device: Traditional simulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
insertion time
time when participants perform flexible videoscope from incisor to carina
Measured: 1 hour
Secondary outcomes (1)
success rate
the rate of participants used flexible videoscope to view carina successfully
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start15 May 2022
- Primary completion30 Jun 2022
- Study completion2 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Difficult AirwayStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenlong Yao (101480), Tongji Hospital
- Investigators
- Wenlong Yao, MD, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327842
- Sponsor's protocol ID
- TJMZK220405
- Status last verified
- Jul 2022
- First submitted
- 6 Apr 2022
- Last updated
- 13 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou Z, Zhang K, Zhao X, Hu Y, He Y, Wan L, Yao W. Evaluation of a 12-hole clock model for improving bronchoscopic skills in simulated normal and difficult airways among anesthesia residents: A randomized controlled study. Medicine (Baltimore). 2024 Jun 7;103(23):e38510. doi: 10.1097/MD.0000000000038510.
PubMed 38847658
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Flexible Videoscope Training Simulator: a Randomized, Controlled, Simulation Teaching Study
- ClinicalTrials.gov ID
- NCT05327842
- Acronym / sponsor ID
- TJMZK220405
- Conditions
- Difficult Airway
- Keywords
- intubation, flexible bronchoscope, difficult airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 15 May 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 2 Jul 2022 (actual)
- First posted
- 14 Apr 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.
Flexible bronchoscope or videoscope plays important roles in managing difficult airway. But this technique is time-consuming and very difficult to learn for novices. The investigators design a simple training simulator to help them master this technique.
Detailed description
In this study, residents without operational experience will be recruited. The training effect of the new simulator will be evaluated by comparison with traditional simulation teaching. Participants will receive training with the new simulator or traditional method for 1hour, and then they perform intubation with flexible videoscope in a simulated difficult airway model. The insertion time and success rate will be recorded. Last, they will complete the questionnaire.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New training simulator | Experimental | Device: New training simulatorParticipants received training with new simulator |
| Traditional method | Active comparator | Device: Traditional simulatorParticipants received traditional training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Resident or Medical student
- Willing to participate to the study
- Consent to evaluate the measured data
Key exclusion criteria (1 listed)
- experienced anesthetists
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 |
|---|---|---|
| New training simulatorParticipants receive training with new simulator | Device | New training simulator |
| Traditional simulatorParticipants receive traditional training | Device | Traditional method |
Primary outcome
insertion time
Time frame: 1 hour
time when participants perform flexible videoscope from incisor to carina
1 secondary outcome
success rate
Time frame: 1 hour
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 13 Jul 2022.
- Derived from this study: PubMed 38847658Zhou Z, Zhang K, Zhao X, Hu Y, He Y, Wan L, Yao W. Evaluation of a 12-hole clock model for improving bronchoscopic skills in simulated normal and difficult airways among anesthesia residents: A randomized controlled study. Medicine (Baltimore). 2024 Jun 7;103(23):e38510. doi: 10.1097/MD.0000000000038510.
- Individual participant dataSharing planned: No
Related trials for Difficult Airway
Enrolling by invitation
Pediatric Intubation Simulations With Bougie
Difficult Airway Intubation
Not yet recruiting
Title of Study: Anesthesiologists' Learning Curves for Ultrasound Assessment of Difficult Airway
Airway Ultrasound, Difficult Airway Management
Not yet recruitingObservational study
LeHeR Maneuver vs Sniffing Position During Video Laryngoscopy in Predicted Difficult Airway
Difficult Airway, Difficult Intubation
Not yet recruitingObservational study
Sniffing Position vs Left Head Rotation (LeHeR) Maneuver for Glottic View During Direct Laryngoscopy
Difficult Intubation, Laryngoscopy
Not yet recruitingObservational study
Prediction of Difficult Mask Ventilation in Obese Population Undergoing Emergency Surgery
Difficult Airway Management
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.
Wenlong Yao, MD principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New training simulator and Traditional simulator in people with Difficult Airway, run by Tongji Hospital 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 3 inclusion and 1 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 13 Jul 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?
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?
insertion time (time frame: 1 hour). 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 NCT05327842, which also lists 1 linked publication.
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 13 Jul 2022; AzTrials last refreshed its copy on 6 Nov 2026.