Distance From the Glottis to the Grille in Children

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.

Study Overview

• Status: Completed
• Conditions: General Anesthesia
• Intervention / Treatment: Procedure: fiberoptic bronchoscope

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• children < 7 years old undergoing elective surgery

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Distance from grille (the end of shaft in supraglottic airway) to glottis is measured using FOB; Other Names: FOB
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; Distance from grille (the end of shaft in supraglottic airway) to glottis is measured using FOB; Other Names: FOB
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; Distance from grille (the end of shaft in supraglottic airway) to glottis is measured using FOB; Other Names: FOB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The distance from grille to glottis	The distance from grille to glottis is measured using fiberoptic bronchoscopy	30 seconds after each supraglottic airway insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	30 seconds after each supraglottic airway insertion

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2017
• Primary Completion (Actual): May 30, 2018
• Study Completion (Actual): May 30, 2018

Study Registration Dates

• First Submitted: May 15, 2017
• First Submitted That Met QC Criteria: May 15, 2017
• First Posted (Actual): May 17, 2017

Study Record Updates

• Last Update Posted (Actual): July 17, 2018
• Last Update Submitted That Met QC Criteria: July 16, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: H1704-133-848

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No