Intubation;DifficultNCT04482166
Learning Curve of Fiberoptic Intubation Through Supraglottic Airway Device
A study testing Training and supraglottic airway device in people with Intubation;Difficult, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aims to obtain learning curve data of residents for fiberoptic-guided tracheal intubation through supraglottic airway device for pediatric difficult airway manikin. Read more about this study
- Who is it for?
- Ages 25 to 40 years
- Conditions the study is for
- Intubation;Difficult
- What is being tested?
- Training and supraglottic airway device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Aug 2020to 31 Aug 2021
- 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 25 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Residents under anesthesiology training with experience of more than 30 times of supraglottic airway device insertion and manipulation of fiberoptic bronchoscope
Who cannot join
- Prior experience of fiberoptic-guided tracheal intubation through supraglottic airway device
- Prior experience of training for fiberoptic-guided tracheal intubation through supraglottic airway device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Learning Curve of Fiberoptic-guided Tracheal Intubation Through Supraglottic Airway Device for Pediatric Difficult Airway Manikin
This study aims to obtain learning curve data of residents for fiberoptic-guided tracheal intubation through supraglottic airway device for pediatric difficult airway manikin.
Read the detailed description
Residents under anesthesiology training will undergo a simulation practice to a pediatric airway manikin, after a single demonstration by an expert for fiberoptic-guided tracheal intubation through supraglottic airway device. The participants will do the same practice 20 times to the same manikin.
- Conditions
- Intubation;Difficult
- Being tested
- Training, supraglottic airway device
- Keywords
- Fiberoptic bronchoscope, Supraglottic airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingOther
20-times training of fiberoptic-guided tracheal intubation through supraglottic airway device to pediatric airway manikin
supraglottic airway deviceDevice
supraglottic airway device
| Study group | Role | What they receive |
|---|---|---|
| Candidates | Experimental | Training of fiberoptic-guided tracheal intubation through supraglottic airway device to pediatric airway manikin Receives: Other: Training; Device: supraglottic airway device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elapsed time to succeed endotracheal intubation for each training period
Measured: From start of each training period to success of endotracheal intubation, not to exceed 10 minutes
Secondary outcomes (5)
Elapsed time to successful insertion of supraglottic airway device and ventilation of the manikin for each training period
Measured: From start of each training period to success of ventilation, not to exceed 10 minutes
Elapsed time to identification of vocal cords via fiberoptic bronchoscope for each training period
Measured: From start of each training period to identification of vocal cords, not to exceed 10 minutes
Elapsed time to introduction of fiberoptic bronchoscope into the trachea for each training period
Measured: From start of each training period to introduction of fiberoptic bronchoscope into the trachea, not to exceed 10 minutes
Success rate of endotracheal intubation for each training period
Measured: From start of each training period to success of endotracheal intubation, not to exceed 10 minutes
Number of trials
Number of trials to succeed ventilation, vocal cord identification, fiberoptic bronchoscope introduction, endotracheal intubation for each training period
Measured: From start of each training period to success of endotracheal intubation, not to exceed 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start17 Aug 2020
- Primary completion22 Jul 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Intubation;DifficultStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji-Hyun Lee, Seoul National University Hospital
- Investigators
- Ji-Hyun Lee, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482166
- Sponsor's protocol ID
- 2006-160-1135
- Status last verified
- Sep 2021
- First submitted
- 19 Jul 2020
- Last updated
- 23 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Stein ML, Park RS, Kovatsis PG. Emerging trends, techniques, and equipment for airway management in pediatric patients. Paediatr Anaesth. 2020 Mar;30(3):269-279. doi: 10.1111/pan.13814. Epub 2020 Feb 5.
PubMed 32022437Hunyady A, Polaner D. Pediatric airway management education and training. Paediatr Anaesth. 2020 Mar;30(3):362-370. doi: 10.1111/pan.13808. Epub 2020 Jan 16.
PubMed 31887239Black AE, Flynn PE, Smith HL, Thomas ML, Wilkinson KA; Association of Pediatric Anaesthetists of Great Britain and Ireland. Development of a guideline for the management of the unanticipated difficult airway in pediatric practice. Paediatr Anaesth. 2015 Apr;25(4):346-62. doi: 10.1111/pan.12615. Epub 2015 Feb 16.
PubMed 25684039Kovatsis PG. Continuous ventilation during flexible fiberscopic-assisted intubation via supraglottic airways. Paediatr Anaesth. 2016 Apr;26(4):457-8. doi: 10.1111/pan.12863. No abstract available.
PubMed 26956516Dalal PG, Dalal GB, Pott L, Bezinover D, Prozesky J, Bosseau Murray W. Learning curves of novice anesthesiology residents performing simulated fibreoptic upper airway endoscopy. Can J Anaesth. 2011 Sep;58(9):802-9. doi: 10.1007/s12630-011-9542-2. Epub 2011 Jun 28.
PubMed 21710368Altun D, Ozkan-Seyhan T, Camci E, Sivrikoz N, Orhan-Sungur M. Learning Curves for Two Fiberscopes in Simulated Difficult Airway Scenario With Cumulative Sum Method. Simul Healthc. 2019 Jun;14(3):163-168. doi: 10.1097/SIH.0000000000000368.
PubMed 30908421Oliveira KF, Arzola C, Ye XY, Clivatti J, Siddiqui N, You-Ten KE. Determining the amount of training needed for competency of anesthesia trainees in ultrasonographic identification of the cricothyroid membrane. BMC Anesthesiol. 2017 Jun 2;17(1):74. doi: 10.1186/s12871-017-0366-7.
PubMed 28577552Orhan-Sungur M, Altun D, Ozkan-Seyhan T, Aygun E, Koltka K, Camci E. Learning curve of ultrasound measurement of subglottic diameter for endotracheal tube selection in pediatric patients. Paediatr Anaesth. 2019 Dec;29(12):1194-1200. doi: 10.1111/pan.13751. Epub 2019 Oct 20.
PubMed 31583796Kim HJ, Park HS, Kim SY, Ro YJ, Yang HS, Koh WU. A Randomized Controlled Trial Comparing Ambu AuraGain and i-gel in Young Pediatric Patients. J Clin Med. 2019 Aug 16;8(8):1235. doi: 10.3390/jcm8081235.
PubMed 31426378Lee JH, Nam S, Jang YE, Kim EH, Kim HS, Kim JT. Clinical performance of Ambu AuraGainTM versus i-gelTM in anesthetized children: a prospective, randomized controlled trial. Anesth Pain Med (Seoul). 2020 Apr 30;15(2):173-180. doi: 10.17085/apm.2020.15.2.173. Epub 2020 Apr 29.
PubMed 33329810
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning Curve of Fiberoptic-guided Tracheal Intubation Through Supraglottic Airway Device for Pediatric Difficult Airway Manikin
- ClinicalTrials.gov ID
- NCT04482166
- Acronym / sponsor ID
- 2006-160-1135
- Conditions
- Intubation;Difficult
- Keywords
- Fiberoptic bronchoscope, Supraglottic airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 22 Jul 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 22 Jul 2020 (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 obtain learning curve data of residents for fiberoptic-guided tracheal intubation through supraglottic airway device for pediatric difficult airway manikin.
Detailed description
Residents under anesthesiology training will undergo a simulation practice to a pediatric airway manikin, after a single demonstration by an expert for fiberoptic-guided tracheal intubation through supraglottic airway device. The participants will do the same practice 20 times to the same manikin.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Candidates | Experimental | Other: Training, Device: supraglottic airway deviceTraining of fiberoptic-guided tracheal intubation through supraglottic airway device to pediatric airway manikin |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Residents under anesthesiology training with experience of more than 30 times of supraglottic airway device insertion and manipulation of fiberoptic bronchoscope
Key exclusion criteria (2 listed)
- Prior experience of fiberoptic-guided tracheal intubation through supraglottic airway device
- Prior experience of training for fiberoptic-guided tracheal intubation through supraglottic airway device
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 |
|---|---|---|
| Training20-times training of fiberoptic-guided tracheal intubation through supraglottic airway device to pediatric airway manikin | Other | Candidates |
| supraglottic airway devicesupraglottic airway device | Device | Candidates |
Primary outcome
Elapsed time to succeed endotracheal intubation for each training period
Time frame: From start of each training period to success of endotracheal intubation, not to exceed 10 minutes
5 secondary outcomes
Elapsed time to successful insertion of supraglottic airway device and ventilation of the manikin for each training period
Time frame: From start of each training period to success of ventilation, not to exceed 10 minutes
Elapsed time to identification of vocal cords via fiberoptic bronchoscope for each training period
Time frame: From start of each training period to identification of vocal cords, not to exceed 10 minutes
Elapsed time to introduction of fiberoptic bronchoscope into the trachea for each training period
Time frame: From start of each training period to introduction of fiberoptic bronchoscope into the trachea, not to exceed 10 minutes
Success rate of endotracheal intubation for each training period
Time frame: From start of each training period to success of endotracheal intubation, not to exceed 10 minutes
Number of trials
Time frame: From start of each training period to success of endotracheal intubation, not to exceed 10 minutes
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 23 Sep 2021.
- Background: PubMed 32022437Stein ML, Park RS, Kovatsis PG. Emerging trends, techniques, and equipment for airway management in pediatric patients. Paediatr Anaesth. 2020 Mar;30(3):269-279. doi: 10.1111/pan.13814. Epub 2020 Feb 5.
- Background: PubMed 31887239Hunyady A, Polaner D. Pediatric airway management education and training. Paediatr Anaesth. 2020 Mar;30(3):362-370. doi: 10.1111/pan.13808. Epub 2020 Jan 16.
- Background: PubMed 25684039Black AE, Flynn PE, Smith HL, Thomas ML, Wilkinson KA; Association of Pediatric Anaesthetists of Great Britain and Ireland. Development of a guideline for the management of the unanticipated difficult airway in pediatric practice. Paediatr Anaesth. 2015 Apr;25(4):346-62. doi: 10.1111/pan.12615. Epub 2015 Feb 16.
- Background: PubMed 26956516Kovatsis PG. Continuous ventilation during flexible fiberscopic-assisted intubation via supraglottic airways. Paediatr Anaesth. 2016 Apr;26(4):457-8. doi: 10.1111/pan.12863. No abstract available.
- Background: PubMed 21710368Dalal PG, Dalal GB, Pott L, Bezinover D, Prozesky J, Bosseau Murray W. Learning curves of novice anesthesiology residents performing simulated fibreoptic upper airway endoscopy. Can J Anaesth. 2011 Sep;58(9):802-9. doi: 10.1007/s12630-011-9542-2. Epub 2011 Jun 28.
- Background: PubMed 30908421Altun D, Ozkan-Seyhan T, Camci E, Sivrikoz N, Orhan-Sungur M. Learning Curves for Two Fiberscopes in Simulated Difficult Airway Scenario With Cumulative Sum Method. Simul Healthc. 2019 Jun;14(3):163-168. doi: 10.1097/SIH.0000000000000368.
- Background: PubMed 28577552Oliveira KF, Arzola C, Ye XY, Clivatti J, Siddiqui N, You-Ten KE. Determining the amount of training needed for competency of anesthesia trainees in ultrasonographic identification of the cricothyroid membrane. BMC Anesthesiol. 2017 Jun 2;17(1):74. doi: 10.1186/s12871-017-0366-7.
- Background: PubMed 31583796Orhan-Sungur M, Altun D, Ozkan-Seyhan T, Aygun E, Koltka K, Camci E. Learning curve of ultrasound measurement of subglottic diameter for endotracheal tube selection in pediatric patients. Paediatr Anaesth. 2019 Dec;29(12):1194-1200. doi: 10.1111/pan.13751. Epub 2019 Oct 20.
- Background: PubMed 31426378Kim HJ, Park HS, Kim SY, Ro YJ, Yang HS, Koh WU. A Randomized Controlled Trial Comparing Ambu AuraGain and i-gel in Young Pediatric Patients. J Clin Med. 2019 Aug 16;8(8):1235. doi: 10.3390/jcm8081235.
- Background: PubMed 33329810Lee JH, Nam S, Jang YE, Kim EH, Kim HS, Kim JT. Clinical performance of Ambu AuraGainTM versus i-gelTM in anesthetized children: a prospective, randomized controlled trial. Anesth Pain Med (Seoul). 2020 Apr 30;15(2):173-180. doi: 10.17085/apm.2020.15.2.173. Epub 2020 Apr 29.
- Individual participant dataSharing planned: No
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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.
Ji-Hyun Lee, M.D., Ph.D. principal investigator
Seoul National University 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 Training and supraglottic airway device in people with Intubation;Difficult, run by Seoul National University Hospital 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 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 23 Sep 2021. 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?
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?
Elapsed time to succeed endotracheal intubation for each training period (time frame: From start of each training period to success of endotracheal intubation, not to exceed 10 minutes). 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 NCT04482166, which also lists 10 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 23 Sep 2021.