General AnesthesiaNCT03156166
Distance From the Glottis to the Grille in Children
A study testing fiberoptic bronchoscope in people with General Anesthesia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Ambu AuraGain, I-gel, Air-Q intubating laryngeal airway are the most commonly used supraglottic airway. In children, they can be used as intubation conduits. However, there has been no guideline for optimal insertion depth of endotracheal tube through those supraglottic airway. Read more about this study
- Who is it for?
- Ages Up to 7 years
- Conditions the study is for
- General Anesthesia
- What is being tested?
- fiberoptic bronchoscope
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Jun 2017to 30 May 2018
- 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 Up to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children < 7 years old undergoing elective surgery
Who cannot join
- difficult airway
- BMI> 30kg/m2
- emergency operation
- cervical spine disease
- history of esophageal disease and surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Distance From the Glottis to the Grille in Children: Ambu AuraGainTM , I-gel, Air-Q Intubating Laryngeal Airway as Intubation Conduits
Ambu AuraGain, I-gel, Air-Q intubating laryngeal airway are the most commonly used supraglottic airway. In children, they can be used as intubation conduits. However, there has been no guideline for optimal insertion depth of endotracheal tube through those supraglottic airway. In this study, the investigators will measure the distance from grille of those supraglottic airways to glottis using fiberoptic bronchoscope in children undergoing anesthesia. This distance allows us to predict an appropriate depth of endotracheal tube when it should be inserted through each supraglottic airway.
- Conditions
- General Anesthesia
- Being tested
- fiberoptic bronchoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fiberoptic bronchoscopeProcedure or surgery
Also called FOB
Distance from grille (the end of shaft in supraglottic airway) to glottis is measured using FOB
| Study group | Role | What they receive |
|---|---|---|
| Ambu AuraGain | Experimental | Ambu AuraGain is inserted in children undergoing general anesthesia. The size of AuraGain is as follows: size 1 for children <5 kg, size 1.5 for 5-10kg, size 2 for 10-20kg, size 2.5 for 20-30kg. Fiberoptic bronchoscope will be performed to measure the distance between the grill and vocal cord. Receives: Procedure: fiberoptic bronchoscope |
| I-gel | Experimental | I-gel is inserted in children undergoing general anesthesia. The size of I-gel is as follows: size 1 for children weighing 2-5kg, size 1.5 for 5-12kg, size 2 for 10-25kg, size 2.5 for 25-35kg. Fiberoptic bronchoscope will be performed to measure the distance between the grill and vocal cord. Receives: Procedure: fiberoptic bronchoscope |
| Air-Q intubating laryngeal airway (ILA) | Experimental | Air-Q ILA is inserted in children undergoing general anesthesia. The size of Air-Q ILA is as follows: size 1 for children between 4-7 kg, size 1.5 for 7-17kg, size 2 for 17-30kg, size 2.5 for 30-50kg. Fiberoptic bronchoscope will be performed to measure the distance between the grill and vocal cord. Receives: Procedure: fiberoptic bronchoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
The distance from grille to glottis
The distance from grille to glottis is measured using fiberoptic bronchoscopy
Measured: 30 seconds after each supraglottic airway insertion
Secondary outcomes (2)
FOB view
score 1: no visible glottis, score 2: visible glottis and anterior epiglottis, score 3: visible glottis and posterior epiglottis, and score 4: only glottis visible
Measured: 30 seconds after each supraglottic airway insertion
Ventilation score
no air leak in airway pressure of 15 cmH2O / bilateral chest wall movement/ normal waveform of capnography
Measured: 30 seconds after each supraglottic airway insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start12 Jun 2017
- Primary completion30 May 2018
- Study completion30 May 2018
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 General AnesthesiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03156166
- Sponsor's protocol ID
- H1704-133-848
- Status last verified
- Jul 2018
- First submitted
- 15 May 2017
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee JH, Park S, Jang YE, Kim EH, Kim HS, Kim JT. The distance between the glottis and the cuff of a tracheal tube placed through three supraglottic airway devices in children: A randomised controlled trial. Eur J Anaesthesiol. 2019 Oct;36(10):721-727. doi: 10.1097/EJA.0000000000001070.
PubMed 31415305
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distance From the Glottis to the Grille in Children: Ambu AuraGainTM , I-gel, Air-Q Intubating Laryngeal Airway as Intubation Conduits
- ClinicalTrials.gov ID
- NCT03156166
- Acronym / sponsor ID
- H1704-133-848
- Conditions
- General Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 17 May 2017 (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.
Ambu AuraGain, I-gel, Air-Q intubating laryngeal airway are the most commonly used supraglottic airway. In children, they can be used as intubation conduits. However, there has been no guideline for optimal insertion depth of endotracheal tube through those supraglottic airway. In this study, the investigators will measure the distance from grille of those supraglottic airways to glottis using fiberoptic bronchoscope in children undergoing anesthesia. This distance allows us to predict an appropriate depth of endotracheal tube when it should be inserted through each supraglottic airway.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ambu AuraGain | Experimental | Procedure: fiberoptic bronchoscopeAmbu AuraGain is inserted in children undergoing general anesthesia. The size of AuraGain is as follows: size 1 for children <5 kg, size 1.5 for 5-10kg, size 2 for 10-20kg, size 2.5 for 20-30kg. Fiberoptic bronchoscope will be performed to measure the distance between the grill and vocal cord. |
| I-gel | Experimental | Procedure: fiberoptic bronchoscopeI-gel is inserted in children undergoing general anesthesia. The size of I-gel is as follows: size 1 for children weighing 2-5kg, size 1.5 for 5-12kg, size 2 for 10-25kg, size 2.5 for 25-35kg. Fiberoptic bronchoscope will be performed to measure the distance between the grill and vocal cord. |
| Air-Q intubating laryngeal airway (ILA) | Experimental | Procedure: fiberoptic bronchoscopeAir-Q ILA is inserted in children undergoing general anesthesia. The size of Air-Q ILA is as follows: size 1 for children between 4-7 kg, size 1.5 for 7-17kg, size 2 for 17-30kg, size 2.5 for 30-50kg. Fiberoptic bronchoscope will be performed to measure the distance between the grill and vocal cord. |
Who may qualify
- Ages
- Up to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children < 7 years old undergoing elective surgery
Key exclusion criteria (5 listed)
- difficult airway
- BMI> 30kg/m2
- emergency operation
- cervical spine disease
- history of esophageal disease and surgery
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 |
|---|---|---|
| fiberoptic bronchoscopeAlso: FOBDistance from grille (the end of shaft in supraglottic airway) to glottis is measured using FOB | Procedure or surgery | Air-Q intubating laryngeal airway (ILA), Ambu AuraGain, I-gel |
Primary outcome
The distance from grille to glottis
Time frame: 30 seconds after each supraglottic airway insertion
The distance from grille to glottis is measured using fiberoptic bronchoscopy
2 secondary outcomes
FOB view
Time frame: 30 seconds after each supraglottic airway insertion
Ventilation score
Time frame: 30 seconds after each supraglottic airway insertion
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 17 Jul 2018.
- Derived from this study: PubMed 31415305Lee JH, Park S, Jang YE, Kim EH, Kim HS, Kim JT. The distance between the glottis and the cuff of a tracheal tube placed through three supraglottic airway devices in children: A randomised controlled trial. Eur J Anaesthesiol. 2019 Oct;36(10):721-727. doi: 10.1097/EJA.0000000000001070.
- 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.
Jin-Tae Kim, PhD 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 fiberoptic bronchoscope in people with General Anesthesia, 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 5 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 17 Jul 2018. 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?
The distance from grille to glottis (time frame: 30 seconds after each supraglottic airway insertion). 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 NCT03156166, 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 17 Jul 2018.