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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03294226
Other study ID # S2017-1229
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 25, 2017
Est. completion date March 24, 2018

Study information

Verified date May 2018
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Children from 6 months to 6 years are randomly allocated into AuraGain group or I-gel group. After anesthetic induction without neuromuscular blocking agent, assigned device in inserted by skillful anesthesiologist. The outcome measures are recorded and analysed.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date March 24, 2018
Est. primary completion date March 23, 2018
Accepts healthy volunteers No
Gender All
Age group 6 Months to 6 Years
Eligibility Inclusion Criteria:

- ASA physical status: 1-3

- age: from 6 months to 6 year

- body weight: 5-20kg

- patients undergoing upper/lower extremity surgery at supine position

Exclusion Criteria:

- patients who do not want to participate in this study

- patients with known difficult airway including congenital facial anomaly or history of difficult airway management

- patients with aspiration risk (gastrointestinal stenosis or stricture)

- patients with symptom of upper respiratory infection on the day of surgery

- patients scheduled for day surgery

- patients judged as not eligible by researchers for other reasons

Study Design


Related Conditions & MeSH terms


Intervention

Device:
AuraGain
After anesthetic induction without neuromuscular blocking agent, AuraGain is inserted.
I-gel
After anesthetic induction without neuromuscular blocking agent, I-gel is inserted.

Locations

Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary requirement of additional airway maneuver including adjustment of head/neck position or insertion depth and taping of the device during placement/maintenance of the device
Secondary insertion time during placement of the device
Secondary success rate during placement of the device
Secondary ease of gastric tube insertion within 10 minutes after device insertion
Secondary adverse effect at operating room aspiration of gastric fluid, hypoxia, SpO2<90%, bronchospasm, dental/tongue/lip trauma, staining of blood on the removed device during anesthesia
Secondary postoperative adverse effect sore throat, hoarseness, airway obstruction within postoperative 24 hours
Secondary fiberoptic view of glottis Brimacombe score within 10 minutes after device insertion
Secondary oropharyngeal leak pressure at 1 minute after device insertion, at 10 minutes after device insertion
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