Distance From the Glottis to the Grille in Children

NCT ID: NCT03156166

Last Updated: 2018-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-12
• Study Completion Date: 2018-05-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

fiberoptic bronchoscope

Intervention Type: PROCEDURE

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

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.

Group Type: EXPERIMENTAL

fiberoptic bronchoscope

Intervention Type: PROCEDURE

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

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.

Group Type: EXPERIMENTAL

fiberoptic bronchoscope

Intervention Type: PROCEDURE

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

Interventions

fiberoptic bronchoscope

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

Intervention Type: PROCEDURE

Other Intervention Names

FOB

Eligibility Criteria

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

• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jin-Tae Kim

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jin-Tae Kim, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 31415305 (View on PubMed)

Other Identifiers

H1704-133-848

Identifier Type: -

Identifier Source: org_study_id