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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03156166
Other study ID # H1704-133-848
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 12, 2017
Est. completion date May 30, 2018

Study information

Verified date July 2018
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 89
Est. completion date May 30, 2018
Est. primary completion date May 30, 2018
Accepts healthy volunteers No
Gender All
Age group N/A to 7 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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