Difficult AirwayNCT02811562
Learning Curves of Intubation for Simulated Difficult Airway Scenarios by Manikin: Comparison of Combined Pentax Airwayscope-fiberoptic Bronchoscope and Fiberoptic Bronchoscope Alone
A study testing manikin, fiberoptic bronchoscope and pentax-airwayscope in people with Difficult Airway, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
Acquisition of knowledge and skills pertinent to the use of fibreoptic endoscopy is an important part of training in various medical and surgical specialties such as anesthesiology, emergency medicine, otolaryngology, and pulmonary medicine. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Difficult Airway
- What is being tested?
- manikin, fiberoptic bronchoscope and pentax-airwayscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2016to Dec 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- resident in Department of anesthesiology
Who cannot join
- resident who has an experience of successful fiberoptic bronchoscopic intubation in difficult case
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Ajou universiry hospital
Suwon, Gyeonggi-do, 16499
Dae Hee Kim, MD, +821034211022, anekim@ajou.ac.kr
About this study
Acquisition of knowledge and skills pertinent to the use of fibreoptic endoscopy is an important part of training in various medical and surgical specialties such as anesthesiology, emergency medicine, otolaryngology, and pulmonary medicine. It has been shown that there is a wide variation in the learning curves of residents and the number of attempts to achieve proficiency in performing upper airway endoscopy. recently, combined use of fiberoptic bronchoscope and videolaryngoscope has been suggested to be a good alternative. So, the aim of this study is to compare the number of attempt to achieve proficiency using fiberoptic bronchoscope alone or fiberoptic bronchoscope with Pentax-AWS.
- Conditions
- Difficult Airway
- Being tested
- manikin, fiberoptic bronchoscope, pentax-airwayscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manikinDevice
fiberoptic bronchoscopeDevice
pentax-airwayscopeDevice
| Study group | Role | What they receive |
|---|---|---|
| fiberoptic bronchoscope | Active comparator | Tracheal intubation in manikin using fiberoptic bronchoscope Receives: Device: manikin; Device: fiberoptic bronchoscope |
| fiberoptic bronchoscope with pentax-airwayscope | Experimental | Tracheal intubation in manikin using fiberoptic bronchoscope with pentax-airwayscope Receives: Device: manikin; Device: fiberoptic bronchoscope; Device: pentax-airwayscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
trial number to achieve 'proficient' in terms of cumulative sum analysis
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult AirwayStudies 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
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DAE HEE KIM, Ajou University School of Medicine
- Investigators
- Dae Hee Kim, MD, Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811562
- Sponsor's protocol ID
- AJIRB-DEV-EXP-16-116
- Status last verified
- Jul 2020
- First submitted
- 16 Jun 2016
- Last updated
- 13 Jul 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning Curves of Intubation for Simulated Difficult Airway Scenarios by Manikin: Comparison of Combined Pentax Airwayscope-fiberoptic Bronchoscope and Fiberoptic Bronchoscope Alone
- ClinicalTrials.gov ID
- NCT02811562
- Acronym / sponsor ID
- AJIRB-DEV-EXP-16-116
- Conditions
- Difficult Airway
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 23 Jun 2016 (estimated)
- 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.
Acquisition of knowledge and skills pertinent to the use of fibreoptic endoscopy is an important part of training in various medical and surgical specialties such as anesthesiology, emergency medicine, otolaryngology, and pulmonary medicine. It has been shown that there is a wide variation in the learning curves of residents and the number of attempts to achieve proficiency in performing upper airway endoscopy. recently, combined use of fiberoptic bronchoscope and videolaryngoscope has been suggested to be a good alternative. So, the aim of this study is to compare the number of attempt to achieve proficiency using fiberoptic bronchoscope alone or fiberoptic bronchoscope with Pentax-AWS.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fiberoptic bronchoscope | Active comparator | Device: manikin, Device: fiberoptic bronchoscopeTracheal intubation in manikin using fiberoptic bronchoscope |
| fiberoptic bronchoscope with pentax-airwayscope | Experimental | Device: manikin, Device: fiberoptic bronchoscope, Device: pentax-airwayscopeTracheal intubation in manikin using fiberoptic bronchoscope with pentax-airwayscope |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- resident in Department of anesthesiology
Key exclusion criteria (1 listed)
- resident who has an experience of successful fiberoptic bronchoscopic intubation in difficult case
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 |
|---|---|---|
| manikin | Device | fiberoptic bronchoscope, fiberoptic bronchoscope with pentax-airwayscope |
| fiberoptic bronchoscope | Device | fiberoptic bronchoscope, fiberoptic bronchoscope with pentax-airwayscope |
| pentax-airwayscope | Device | fiberoptic bronchoscope with pentax-airwayscope |
Primary outcome
trial number to achieve 'proficient' in terms of cumulative sum analysis
Time frame: up to 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
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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.
Dae Hee Kim, MD principal investigator
Ajou University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing manikin, fiberoptic bronchoscope and pentax-airwayscope in people with Difficult Airway, run by Ajou University School of Medicine at 1 site in South Korea.
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 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: status not confirmed, as of the sponsor's last update on 13 Jul 2020. 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 South Korea. 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?
Contact Dae Hee Kim, MD (82-10-3421-1022, anekim@ajou.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
trial number to achieve 'proficient' in terms of cumulative sum analysis (time frame: up to 2 weeks). 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 13 Jul 2020.