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CompletedNCT03156166Updated Jul 17, 2018

Distance From the Glottis to the Grille in Children

An interventional study of fiberoptic bronchoscope in General Anesthesia, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged Up to 7 Years. Per ClinicalTrials.gov, last updated 2018-07-17.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
89
Allocation
Randomized
Ages
Up to 7 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • General Anesthesia
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In context

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 7 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • children \< 7 years old undergoing elective surgery

Exclusion criteria

Exclusion Criteria:

  • difficult airway
  • BMI> 30kg/m2
  • emergency operation
  • cervical spine disease
  • history of esophageal disease and surgery
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
89 participants (actual)

Study arms

  • Experimental
    Ambu AuraGain

    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.

    Procedure: fiberoptic bronchoscope

  • Experimental
    I-gel

    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.

    Procedure: fiberoptic bronchoscope

  • Experimental
    Air-Q intubating laryngeal airway (ILA)

    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.

    Procedure: fiberoptic bronchoscope

Interventions

  • Procedurefiberoptic bronchoscope

    Distance from grille (the end of shaft in supraglottic airway) to glottis is measured using FOB

    Also known as: FOB

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What researchers measure

Primary outcomes

  1. The distance from grille to glottis

    The distance from grille to glottis is measured using fiberoptic bronchoscopy

    Time frame: 30 seconds after each supraglottic airway insertion

Secondary outcomes

  1. 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

    Time frame: 30 seconds after each supraglottic airway insertion

  2. Ventilation score

    no air leak in airway pressure of 15 cmH2O / bilateral chest wall movement/ normal waveform of capnography

    Time frame: 30 seconds after each supraglottic airway insertion

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Study locations

1 site
  • Seoul National University Hospital
    Seoul, 110-744, Korea, Republic of
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References and documents

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 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03156166
Lead sponsor
Seoul National University Hospital
Responsible party
Jin-Tae Kim (professor, Seoul National University Hospital) — Principal investigator
First posted
May 17, 2017
Start date
Jun 12, 2017
Primary completion
May 30, 2018
Completion
May 30, 2018
Last update
Jul 17, 2018

Study contacts

Jin-Tae Kim, PhD
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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