Distance From the Glottis to the Grille in Children

NCT03156166 | Completed DMC

• 1 other identifier: H1704-133-848
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

General Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• FOB view

  30 seconds after each supraglottic airway insertion

• Ventilation score

  30 seconds after each supraglottic airway insertion

Study Arms (3)

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.

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.

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.

Procedure: fiberoptic bronchoscope

Interventions

fiberoptic bronchoscope PROCEDURE

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

Also known as: FOB

Air-Q intubating laryngeal airway (ILA); Ambu AuraGain; I-gel

Eligibility Criteria

• Age: Up to 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children \< 7 years old undergoing elective surgery

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

• 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.

  PMID: 31415305 DERIVED

Study Officials

• Jin-Tae Kim, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 17, 2017
• Study Start: June 12, 2017
• Primary Completion: May 30, 2018
• Study Completion: May 30, 2018
• Last Updated: July 17, 2018

Record last verified: 2018-07

Locations

KR (1)